Multiple Sclerosis (MS) is a neuroinflammatory disorder which affects 2.8 million people world-wide. A growing body of evidence shows ethnic disparities in MS. This review aims to evaluate differences, based upon ethnic background, in the incidence, prevalence, disease course, and efficacy of disease-modifying therapies (DMTs) among people with MS (PwMS).

METHOD:

Ethnicities were classified as White, Black, Hispanic, Asian, and Middle Eastern and North African (MENA). A literature search was conducted using the PubMed search engine to identify articles on MS and ethnicity that were published in the English language between 01/01/2005 and 31/05/2022.

RESULTS:

101 studies met all inclusion criteria. Although the incidence and prevalence of MS varied among ethnicities, findings were inconsistent and depended on the continent of the study. Ethnicity may have an impact on the disease course. PwMS from Black, Hispanic, and MENA, but not Asian ethnicities, appeared to accumulate physical disability at a faster rate than those from White ethnicity. Although there was a lack of studies evaluating the relative safety and efficacy of DMTs among various ethnicities, interferon-beta was found to be less efficacious in PwMS from Black ethnicity.

CONCLUSIONS:

Further studies, with more uniform definitions of ethnicity are required to comprehensively understand ethnic disparities in MS, in particular to identify underlying causes, to facilitate the delivery of personalised medical care and avoid inequity.

01 Jan 2024·European review for medical and pharmacological sciences

Utilization of peginterferon-β-1a in the real-world practice for relapsing-remitting multiple sclerosis.

Article

Author: Brescia Morra, V ; Caliendo, D ; Lanzillo, R ; Palladino, R ; Moccia, M ; Triassi, M ; Rubba, F ; Affinito, G ; Santoni, L ; Vaccari, I

OBJECTIVE:

Peginterferon β-1a (PEG-IFN-β-1a) is the most recent interferon beta formulation approved for treating relapsing-remitting multiple sclerosis (RRMS). We aim to describe the real-world utilization of PEG-IFN-β-1a in RRMS and compare it with other injectable disease-modifying therapies (DMTs).

PATIENTS AND METHODS:

In this population-based study, we used 2015-2019 routinely collected healthcare data of the Campania region of Italy from National Healthcare System DMT prescriptions, inpatient and outpatient clinical records of hospitals in Campania, and the Federico II University MS clinical registry for a subset of patients. We included individuals with RRMS receiving new prescriptions of PEG-IFN-β-1a [n=281; age = 38.8±12.3 years; females=70.5%; disease duration = 8.4±8.3 years; Expanded Disability Status Scale (EDSS) at baseline=2.0 (1.0-6.5)], glatiramer acetate [n=751; age = 46.0±11.4 years; females=67.1%; disease duration = 9.8±8.2 years; EDSS=4.0 (1.5-8.5)], and subcutaneous (SC) IFN-β-1a [n=1,226; age = 39.7±11.7 years; females=66.5%; disease duration = 8.2±6.5 years; EDSS 2.5 (1.5-6.5)]. Adherence [medication possession ratio (MPR)], escalation to more effective DMTs, hospitalization rates and costs were measured. We used mixed-effect linear regression models (for adherence, hospitalization rates and costs) and Cox regression models (for escalation) to assess differences between PEG-IFN-β-1a (statistical reference), glatiramer acetate, and SC IFN-β-1a. All models included age, sex, previous treatment/untreated, year of treatment initiation, treatment duration, and adherence as covariates.

RESULTS:

Adherence was lower in glatiramer acetate (MPR = 0.91±0.1; Coeff=-0.11; p<0.01), and IFN-β-1a (MPR = 0.92±0.1; Coeff=-0.08; p<0.01), compared with PEG-IFN-β-1a (MPR = 1.01±0.1). The probability of escalating to more effective DMTs was higher for glatiramer acetate (14.9%; HR=4.09; p<0.01) and IFN-β-1a (9.1%; HR=3.35; p=0.01), compared with PEG-IFN-β-1a (4.9%). No differences in annualized hospitalization rates were identified between glatiramer acetate [annualized hospitalization rates (AHR) = 0.05±0.30; Coeff=0.02; p=0.31), IFN-β-1a (AHR = 0.02±0.21; Coeff=0.01; p=0.97], and PEG-IFN-β-1a (AHR = 0.02±0.24); however, monthly costs for MS admissions were higher for glatiramer acetate (€49.45±€195.27; Coeff=-29.89; p=0.03), compared with IFN-β-1a (€29.42±€47.83; Coeff=6.79; p=0.61), and PEG-IFN-β-1a (€23.91±€43.90).

CONCLUSIONS:

SC PEG-IFN-β-1a and IFN-β-1a were used in relatively similar populations, while glatiramer acetate was preferred in older and more disabled patients. PEG-IFN-β-1a was associated with higher adherence and lower escalation rates toward more effective (and costly) DMTs.

02 Dec 2023·Expert review of neurotherapeutics

An update on combination therapies for multiple sclerosis: where are we now?

Review

Author: Sellebjerg, Finn ; Magyari, Melinda ; Sorensen, Per Soelberg

INTRODUCTION:

In theory, combination of two agents, which are suboptimal when given individually, may result in a significant increase in therapeutic effect. Combination therapies have proven particularly effective against infections such as HIV, cancer, and also chronic autoimmune diseases such as rheumatoid arthritis.

AREAS COVERED:

The authors review the literature, searching for randomized placebo-controlled or comparative, double-blind or investigator-blinded clinical trials, not including open label clinical trials, of treatment of multiple sclerosis (MS) with combination therapy or add-on therapy, including trials of induction therapy, trials for prevention of disease activity or worsening, amelioration of adverse effects, and treatment of relapses, and trials to increase remyelination.

EXPERT OPINION:

Combination of two platform therapies (Interferon-beta or glatiramer acetate) was without additional effect. Clinical trials with add-on, often applying repurposed drugs (e.g. simvastatin, atorvastatin, minocycline, estriol, cyclophosphamide, azathioprine, albuterol, vitamin D), have been negative, apart from monthly methylprednisolone that, however, had low tolerability. Combination therapy for neuroprotection/remyelination showed some interesting results, though we are still awaiting results of phase III trials. The results of combination of anti-inflammatory therapies have in general been disappointing. In the future, combination of new effective neuroprotective/remyelinating drugs and highly effective anti-inflammatory treatments may benefit people with MS.

News (Medical) associated with Interferon Beta(Toray Industries, Inc.)

29 Feb 2024

·www.businesswire.com

EMD Serono Presents New MAVENCLAD® Data Supporting Cognitive Function Benefits

ROCKLAND, Mass--( BUSINESS WIRE )--EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the presentation of two new post-hoc analyses of tertiary endpoints from the MAGNIFY-MS study, a Phase IV, prospective, open-label study evaluating the efficacy and safety of MAVENCLAD ® (cladribine) tablets in highly active relapsing multiple sclerosis (RMS). The first presentation examines the stability or improvement in cognitive processing speed over a two-year period, suggesting the potential of MAVENCLAD to maintain or improve cognitive function in patients with highly active RMS. Additionally, interim findings from year three of the MAGNIFY-MS extension trial underscore the continued efficacy and safety profile of MAVENCLAD, which is consistent with earlier safety data. These data are being presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024. The post-hoc analysis from 270 patients showed a clinically meaningful benefit in cognitive processing speed in patients treated with MAVENCLAD. Cognitive benefit was seen following the first treatment course and became more pronounced by month 18 when patients had received the full treatment course. At two years, the estimated rate of stability or sustained improvement was more than 95% with an 8-point score change on the Symbol Digit Modality Test (SDMT), a measure of cognitive processing speed. “Our decades of experience in multiple sclerosis have brought us clarity around the cognitive issues that affect over half of individuals with MS,” said Lori Lebson, Senior Vice President, North America Medical Affairs, EMD Serono. “Based on these findings from MAGNIFY-MS, where the majority of patients on MAVENCLAD had either cognitive improvement or stability at two years, we are optimistic about a future where the burden of cognitive changes in MS can be reduced.” Cognitive symptoms often have a profound impact on daily living and the quality of life in people living with MS. They can touch multiple aspects of a person’s life, such as employment, social life, including relationships, and even participating in their own healthcare decisions. 1 Also being presented are the year three findings from an interim analysis of the extension trial of the MAGNIFY-MS study which showed sustained efficacy of MAVENCLAD, one year following completion of the two treatment courses. The No Evidence of Disease Activity-3 (NEDA-3) rates during year three were 85.99% for treatment naïve and 76.86% for those previously treated, based on the assessment of 219 patients. NEDA-3 status is defined as patients with no relapse, no 6-month Expanded Disability Status Scale (EDSS) progression and no T1 gadolinium-enhancing (Gd+) or active T2 lesions. The majority of patients (90.4%) were free of qualifying relapses and overall EDSS remained stable. Sustained improvements in MRI outcomes were seen: T1 Gd+ counts and annualized active T2 lesion counts showed a decrease from baseline to month 24 and month 36. These findings further support the continued benefits of MAVENCLAD following completion of the two-year treatment course. About MAVENCLAD ® MAVENCLAD, approved by the U.S. Food and Drug Administration (FDA) on March 29, 2019, is the first and only short-course oral therapy for the treatment of adults with relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS). Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of multiple sclerosis (MS), and MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS). Patients should follow healthcare provider instructions including cancer screening, contraception and blood tests. The approved dose of MAVENCLAD is 3.5 mg per kg body weight over two years, administered as one treatment course of 1.75 mg per kg per year, each consisting of two treatment weeks. The mechanism by which cladribine exerts its therapeutic effects in patients with multiple sclerosis has not been fully elucidated but is thought to involve cytotoxic effects on B and T lymphocytes through impairment of DNA synthesis, resulting in depletion of lymphocytes. MAVENCLAD causes a dose-dependent reduction in lymphocyte counts followed by recovery. Because cladribine is cytotoxic, special handling and disposal instructions should be followed. IMPORTANT SAFETY INFORMATION WARNING: MALIGNANCIES and RISK OF TERATOGENICITY Treatment with MAVENCLAD may increase the risk of malignancy. MAVENCLAD is contraindicated in patients with current malignancy. In patients with prior malignancy or with increased risk of malignancy, evaluate the benefits and risks of the use of MAVENCLAD on an individual patient basis. Follow standard cancer screening guidelines in patients treated with MAVENCLAD. MAVENCLAD is contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception because of the potential for fetal harm. Malformations and embryolethality occurred in animals. Exclude pregnancy before the start of treatment with MAVENCLAD in females of reproductive potential. Advise females and males of reproductive potential to use effective contraception during MAVENCLAD dosing and for 6 months after the last dose in each treatment course. Stop MAVENCLAD if the patient becomes pregnant. CONTRAINDICATIONS Patients with current malignancy. Pregnant women, and women and men of reproductive potential who do not plan to use effective contraception during and for 6 months after the last dose in each treatment course. May cause fetal harm. Patients infected with human immunodeficiency virus (HIV). Patients with active chronic infections (e.g., hepatitis or tuberculosis). Patients with a history of hypersensitivity to cladribine. Women intending to breastfeed on a MAVENCLAD treatment day and for 10 days after the last dose. WARNINGS AND PRECAUTIONS Malignancies: Treatment with MAVENCLAD may increase the risk of malignancy. After the completion of 2 treatment courses, do not administer additional MAVENCLAD treatment during the next 2 years. In clinical studies, patients who received additional MAVENCLAD treatment within 2 years after the first 2 treatment courses had an increased incidence of malignancy. The risk of malignancy with reinitiating MAVENCLAD more than 2 years after the completion of 2 treatment courses has not been studied. Follow standard cancer screening guidelines in patients treated with MAVENCLAD. Risk of Teratogenicity: MAVENCLAD may cause fetal harm when administered to pregnant women. In females of reproductive potential, exclude pregnancy before initiation of each treatment course of MAVENCLAD and prevent by the use of effective contraception during MAVENCLAD dosing and for at least 6 months after the last dose of each treatment course. Women who become pregnant during treatment with MAVENCLAD should discontinue treatment. Lymphopenia: MAVENCLAD causes a dose-dependent reduction in lymphocyte count. Concomitant use of MAVENCLAD with hematotoxic drugs may increase the risk of adverse reactions because of the additive hematological effects. Monitor lymphocyte counts before, during, and after treatment. Infections: Serious, including life-threatening or fatal, infections have occurred. MAVENCLAD reduces the body's immune defense, and an increased risk of infections has been observed in patients receiving MAVENCLAD. Infections occurred in 49% of MAVENCLAD-treated patients compared to 44% of patients treated with placebo in clinical studies; serious or severe infections occurred in 2.4% of MAVENCLAD- treated patients and 2.0% of placebo-treated patients. The most frequent serious infections included herpes zoster and pyelonephritis. Fungal infections were observed, including cases of coccidioidomycosis. Single fatal cases of tuberculosis and fulminant hepatitis B were reported in the clinical program. Screen patients for active and latent infections (tuberculosis, hepatitis B or C). Delay treatment until infection is fully resolved or controlled. Vaccinate patients who are seronegative for varicella zoster virus (VZV) prior to treatment. Vaccinate patients who are seropositive to VZV with recombinant, adjuvanted zoster vaccine either prior to or during treatment, including when their lymphocyte counts are less than or equal to 500 cells per microliter. Administer anti-herpes prophylaxis in patients with lymphocyte counts less than 200 cells per microliter. Monitor for infections. Progressive multifocal leukoencephalopathy (PML) has been reported in patients treated with parenteral cladribine for oncologic indications. No case of PML has been reported in clinical studies of cladribine in patients with MS. Obtain a baseline magnetic resonance imaging (MRI) within 3 months before initiating the first treatment course of MAVENCLAD. At the first sign of PML, withhold MAVENCLAD and perform an evaluation. Administer all immunizations (except as noted for VZV) according to immunization guidelines prior to starting MAVENCLAD. Administer live-attenuated or live vaccines at least 4 to 6 weeks prior to starting MAVENCLAD due to risk of infection. Hematologic Toxicity: In addition to lymphopenia, decreases in other blood cells and hematological parameters have been reported with MAVENCLAD in clinical studies. Obtain complete blood count (CBC) with differential including lymphocyte count before and during treatment, periodically thereafter, and when clinically indicated. Graft-versus-Host Disease with Blood Transfusions: Transfusion-associated graft-versus-host disease has been observed rarely after transfusion of nonirradiated blood in patients treated with cladribine for non-MS treatment indications. In patients who require blood transfusion, irradiation of cellular blood components is recommended. Liver Injury: In clinical studies, 0.3% of MAVENCLAD-treated patients had liver injury (serious or causing treatment discontinuation) compared to 0 placebo patients. Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels prior to treatment. Discontinue MAVENCLAD if clinically significant liver injury is suspected. Hypersensitivity: If a hypersensitivity reaction is suspected, discontinue MAVENCLAD therapy. Do not use MAVENCLAD in patients with a history of hypersensitivity to cladribine. Cardiac Failure: In clinical studies, one MAVENCLAD-treated patient experienced life-threatening acute cardiac failure with myocarditis, which improved after approximately one week. Cases of cardiac failure have also been reported with parenteral cladribine used for treatment indications other than multiple sclerosis. Instruct patients to seek medical advice if they experience symptoms of cardiac failure (e.g., shortness of breath, rapid or irregular heartbeat, swelling). Adverse Reactions: The most common adverse reactions (incidence of >20%) are upper respiratory tract infection, headache, and lymphopenia. Drug Interactions: Concomitant use of with immunosuppressive or myelosuppressive drugs and some immunomodulatory drugs (e.g., interferon beta) is not recommended and may increase the risk of adverse reactions. Acute short-term therapy with corticosteroids can be administered. Monitor for additive effects on the hematological provide with use of hemotoxic drugs. Avoid concomitant use of antiviral and antiretroviral drugs. Avoid concomitant use of BCRP or ENT/CNT inhibitors as they may alter bioavailability of MAVENCLAD. Use in Specific Populations: Studies have not been performed in pediatric, or elderly patients >65 years, pregnant or breastfeeding women. Use in patients with moderate to severe renal or hepatic impairment is not recommended. To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono, Inc. at 1-800-283-8088 ext. 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Please see the full Prescribing Information , including BOXED WARNING for additional information. About Multiple Sclerosis Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.8 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common. EMD Serono, Inc. and Multiple Sclerosis For more than 20 years, EMD Serono has been relentlessly focused on understanding the journey people living with MS face in order to create a meaningful, positive experience for them and the broader MS community. However, there is still much that is unknown about this complex and unpredictable disease. EMD Serono is digging deeper to advance the science. About EMD Serono, Inc. EMD Serono - the healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada - aspires to create, improve and prolong life for people living with difficult-to-treat conditions like infertility, multiple sclerosis and cancer. The business is imagining the future of healthcare by working to translate the discovery of molecules into potentially meaningful outcomes for people with serious unmet medical needs. EMD Serono’s global roots go back more than 350 years with Merck KGaA, Darmstadt, Germany. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations in Massachusetts. www.emdserono.com . About Merck KGaA, Darmstadt, Germany Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across life science, healthcare and electronics. More than 64,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2022, Merck KGaA, Darmstadt, Germany, generated sales of € 22.2 billion in 66 countries. The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. 1 Morrow SA, Kruger P, Langdon D, Alexandri N. What Is the True Impact of Cognitive Impairment for People Living with Multiple Sclerosis? A Commentary of Symposium Discussions at the 2020 European Charcot Foundation. Neurol Ther. 2023 Oct;12(5):1419-1429. doi: 10.1007/s40120-023-00519-z. Epub 2023 Jul 19. PMID: 37466762; PMCID: PMC10444737.

Clinical ResultDrug ApprovalPhase 2Phase 3

06 Dec 2023

·www.globenewswire.com

MediciNova Receives a Notice of Decision to Grant for a New Patent Covering MN-166 (ibudilast) for the Treatment of Progressive MS in Europe

LA JOLLA, Calif., Dec. 06, 2023 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced it has received a Notice of Decision to Grant from the European Patent Office for a pending patent application which covers the combination of MN-166 (ibudilast) and interferon-beta for the treatment of progressive multiple sclerosis (progressive MS). Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than October 2039. The allowed claims cover a combination of MN-166 (ibudilast) and interferon-beta for use in a method of treating, alleviating the negative effects of, or slowing the progression of progressive multiple sclerosis in patients previously treated with interferon-beta. The allowed claims cover MN-166 (ibudilast) and interferon-beta administered in separate dosage forms, administered in the same dosage form, administered simultaneously, or administered consecutively. The allowed claims specifically cover the treatment of both primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS). The allowed claims cover a wide range of doses of both MN-166 (ibudilast) and interferon-beta, a wide range of dosing durations for the combination, and a range of different dosing frequencies for interferon-beta. Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc., commented, "We are very pleased to receive notice that this new patent will be granted in Europe and we believe it could increase the potential value of MN-166. Our analysis of the data from our completed Phase 2b trial in progressive MS indicated that there may be a synergistic effect of the combination of MN-166 and interferon-beta which could result in an even lower risk of disability progression compared to the risk reduction for MN-166 alone. The U.S. Patent and Trademark Office previously granted a similar patent covering this combination for the treatment of progressive MS." About MN-166 (ibudilast) MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS). About MediciNova MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants. Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by, or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," "considering," "planning" or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2022 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements. INVESTOR CONTACT: Geoff O'BrienVice PresidentMediciNova, Inc.info@medicinova.com

Phase 2

06 Nov 2023

·www.biospace.com

Ainos Signs MoU for Contract Clinical Trials to Conduct Clinical Study of Potential New Animal Drug Based on VELDONA

Ainos and SIDSCO will cooperate to accelerate the development of new animal drugs based on Ainos' VELDONA® low-dose oral interferon Upcoming clinical study will investigate VELDONA®'s safe use and efficacy for the treatment of feline chronic gingivostomatitis (FCGS) via oral mucosal administration SAN DIEGO, CA / ACCESSWIRE / November 6, 2023 / Ainos, Inc. (NASDAQ:AIMD, AIMDW) ("Ainos", or the "Company"), a diversified healthcare company focused on the development of AI-powered point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced that it had signed a Memorandum of Understanding ("MoU") with SIDSCO Biomedical Co., Ltd. ("SIDSCO"). The MoU is an important step in Ainos' strategy to expand its product line into the global pet care market. Under the agreement, Ainos and SIDSCO (collectively, the "Parties") will jointly explore the feasibility of VELDONA®/Cytoprotein contract clinical trials. Ainos intends to conduct animal clinical trials for veterinary investigational medicines in conjunction with SIDSCO, and will provide the technical knowledge, funding, and assistance required for the project. Ainos' low-dose oral interferon alpha ("IFNα") formulation, VELDONA®, is a human interferon first approved for sale by the Texas Department of Health in 1985 for the treatment of cats with feline leukemia and dogs with canine parvovirus. In 28 previous studies performed by Ainos, VELDONA® was found to exhibit systemic effects in mice, cats, dogs, ferrets, chickens, rats, guinea pigs, horses, calves/cows, and particularly pigs. VELDONA® has aided in boosting feed conversion efficiency and fighting deadly viral infections in these species, including canine parvovirus, equine herpesvirus, feline coronavirus, and others. These studies demonstrate that VELDONA® has a therapeutic or preventive effect via the oral mucosa. At the same time, VELDONA® modulates systemic and mucosal immunity without serious side effects. Previous studies have confirmed that feline interferon administered to the local oral mucosa can improve the clinical symptoms of pain in cats and the degree of inflammation in the affected area, and no serious adverse drug reactions occurred during the trial period. The experience of many veterinarians using over-the-counter medications has also shown that many cases of feline chronic gingivostomatitis (FCGS) have been significantly improved through the use of interferons. It can be seen that interferon has a good effect on chronic gingivostomatitis in cats, and it has no adverse effects when used in combination with other drugs. The results of the Agricultural Science and Technology Research Institute's potency and cytotoxicity tests on VELDONA® using feline macrophages (fcwf-4) confirmed its antiviral efficacy and established an effective and safe dosage. Ainos' upcoming clinical trial, expected to be held in cooperation with SIDSCO at Mercy Animal Medical Center, will investigate VELDONA®'s safe use and efficacy for the treatment of FCGS in cats via oral mucosal administration. FCGS is characterized by severe inflammation of the gingiva, buccal mucosa, and caudal oral mucosa. There are two types of FCGS. Type 1 includes cases with alveolar and labial/buccal mucositis/stomatitis only, while Type 2 covers cases with caudal mucositis/stomatitis, with or without alveolar and labial/buccal mucositis/stomatitis. The exact cause of FCGS is still unknown. It seems that cats with FCGS have a hyperimmune reaction to plaque, bacteria, viruses, or environmental factors which leads to excessive inflammation. FCGS is a common condition, with a reported prevalence ranging from 0.7% to 12.0%. The most favorable clinical control for resolution of oral inflammation is via partial or full mouth complete tooth extractions. Dental extractions have been shown to cure FCGS in 55% of cases, markedly improve symptoms in 35% of cases, and have no effect in 10% of cases. Refractory FCGS requires lifelong medication, including immunosuppressants such as corticosteroids or cyclosporine, or immunomodulators such as Feline Interferon Omega. However, due to the potential deleterious side-effects of long-term corticosteroid administration, these should only be used as needed for symptomatic alleviation during the acute phase. Currently, medical management of FCGS remains highly variable and often depends on comorbidities in each individual case. Generally, existing medical therapies for FCGS include antibiotics, antihistamines, and immunosuppressants, such as corticosteroids or cyclosporine, which are often first-line treatments for affected animals. However, these immunosuppressants have serious long-term side effects, including type 2 diabetes and opportunistic infections. Currently, there are no medications for animals that do not respond to anti-inflammatory or immunosuppressive treatments, and there are no ideal long-term solutions available to pet owners. A report compiled by Grand View Research shows that the global pet dental health market is projected to grow at a CAGR of 6.2%, reaching US$9.98 billion by 2030. The canine market segment accounted for the largest revenue share at over 55.0%, and the feline market segment is anticipated to expand at a CAGR of 6.9%. Cat ownership in the United States is estimated at 85.5 million, suggesting that as many as 10.3 million cats have FCGS. Companion animal ownership continues to rise in the United States, especially among young people. About 35% of American households own a cat. In addition to Taiwan, Ainos is actively working to take advantage of larger market opportunities with sales in Asia and the United States. Ainos' upcoming clinical trial is expected to be sent to the United States' Internal Animal Care and Use Committee (IACUC) for review in December this year. The clinical trial is a small-scale field pre-trial. It is expected to start accepting cases in the first quarter of next year, and to complete admission of 15-30 cats in the second quarter. If the results of this trial meet the expected efficacy requirements, the Company will submit a formal application to Taiwan's Bureau of Prevention and Inspection of the Ministry of Agriculture for animal new drug field trials. This would represent a significant step forward in the process of obtaining an animal new drug license. Ainos plans to conduct the upcoming clinical study in cooperation with SIDSCO at Mercy Animal Medical Center. Chun-Hsien (Eddy) Tsai, Chairman of the Board, President, and Chief Executive Officer of Ainos, commented, "We are thrilled to be taking this significant step in the further advancement of VELDONA® within the pet health space. The global pet care market is massive, estimated at $223 billion in 2021, making this the perfect time for us to expand our VELDONA® portfolio to include a potential treatment option for one of the most common ailments among domestic cats. By signing this MoU with SIDSCO, we are intent on accelerating the drug development process, and we believe our collaboration will bring substantial benefits to both parties. We remain steadfast in our commitment to providing pet owners with safe and effective solutions to safeguard their animals' health, and I look forward to our team working side-by-side with SIDSCO to make this goal a reality." About Ainos, Inc. Headquartered in San Diego, California, Ainos is a diversified healthcare company focused on the development of novel point-of-care testing ("POCT"), low-dose VELDONA® interferon therapeutics, and synthetic RNA-driven preventative medicine. The company's products include VELDONA® clinical-stage human therapeutics, VELDONA® Pet cytoprotein health supplements, and telehealth-friendly POCTs powered by its AI Nose technology platform. The lead POCT candidate, Ainos Flora, is intended to be a telehealth-friendly POCT for women's health and certain common sexually transmitted infections ("STIs"). To learn more, visit . Follow Ainos on X, formerly known as Twitter, (@AinosInc) and LinkedIn to stay up-to-date. About SIDSCO Biomedical Co., Ltd SIDSCO, which stands for Scientific Integration Design Service Corporation, is a Taiwanese contract research organization (CRO) founded in 2018. SIDSCO focuses on providing systematic and customized preclinical experimental integration outsourcing services, which include experiment design, material preparation, experiment execution, report writing, and evidence counseling. SIDSCO is fully accredited by the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC), and has been certified for both OECD GLP and TFDA GLP. Visit for more information. About Mercy Animal Medical Center Founded in 1998, Mercy Animal Medical Center's mission is to safeguard animals' medical care and to educate pet owners about better animal health. It currently employs 60 specialized veterinarians to diagnose and treat a wide range of pets, including rabbits, rodents, snakes, lizards, turtles, parrots, sugar gliders, raccoons, hedgehogs, and more. It is equipped with advanced instruments and benefits from professional collaboration with specialized departments, ensuring that every patient receives the most appropriate medical care. Mercy Animal Center is affiliated with Jong-Shing Animal Hospital. Visit for more information. Forward-Looking Statements This press release contains "forward-looking statements" about Ainos within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "anticipate," "believe," "estimate," "approximate," "expect," "intend," "plan," "predict," "project," "target," "future," "likely," "strategy," "foresee," "may," "guidance," "potential," "outlook," "forecast," "should," "will" or other similar words or phrases. Similarly, statements that describe the Company's objectives, plans or goals are, or may be, forward-looking statements. Forward-looking statements are based only on the Company's current beliefs, expectations, and assumptions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. The Company's actual results may differ materially from those indicated in the forward-looking statements. Important factors that could cause the Company's actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release include, among others, the cost of production and sales potential of the planned drug treatments announced in this press release; the Company's dependence on projected revenues from the sale of COVID-19 test kits and its VELDONA® Pet line of supplements ; the Company's limited cash and history of losses; the Company's ability to achieve profitability; the Company's ability to raise additional capital to continue the Company's product development; the ability to accurately predict the future operating results of the Company; the ability to advance Ainos' current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates the Company develops; the ability to obtain and maintain regulatory approval of Ainos' product candidates; delays in completing the development and commercialization of the Company's current and future product candidates, which could result in increased costs to the Company, delay or limit the ability to generate revenue and adversely affect the business, financial condition, results of operations and prospects of the Company; intense competition and rapidly advancing technology in the Company's industry that may outpace its technology; customer demand for the products and services the Company develops; the impact of competitive or alternative products, technologies and pricing; disruption in research and development facilities; lawsuits and other claims by third parties or investigations by various regulatory agencies governing the Company's operations; potential cybersecurity attacks; increased requirements and costs related to cybersecurity; the Company's ability to realize the benefits of third party licensing agreements; the Company's ability to obtain and maintain intellectual property protection for Ainos product candidates; compliance with applicable laws, regulations and tariffs; continued listing on and compliance with the applicable regulations of the Nasdaq Capital Market; and the Company's success in managing growth. A more complete description of these risk factors and others is included in the "Risk Factors" section of Ainos' Annual Report on Form 10-K for the year ended December 31, 2022 and other reports filed with the U.S. Securities and Exchange Commission ("SEC"), many of which risks are beyond the Company's control. In addition to the risks described above and in the Company's reports filed with the SEC, other unknown or unpredictable factors also could cause actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release. The forward-looking statements made in this press release are expressly qualified in their entirety by the foregoing cautionary statements. Ainos undertakes no obligation to, and expressly disclaims any such obligation to, publicly update or revise any forward-looking statement to reflect changed assumptions, the occurrence of anticipated or unanticipated events or changes to the future results over time or otherwise, except as required by law. Investor Relations Contact ICR, LLC Robin Yang Tel: +1 646-224-6971 Email: Ainos.IR@icrinc.com SOURCE: Ainos, Inc. View source version on accesswire.com:

Clinical StudyDrug Approval

100 Deals associated with Interferon Beta(Toray Industries, Inc.)

External Link

KEGG	Wiki	ATC	Drug Bank
D03304	Interferon Beta(Toray Industries, Inc.)	L03AB02	DB14999

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Astrocytoma	JP	-	01 Apr 1985
Glioblastoma	JP	-	01 Apr 1985
Hepatitis B	JP	-	01 Apr 1985
Hepatitis C	JP	-	01 Apr 1985
Medulloblastoma	JP	-	01 Apr 1985
Melanoma	JP	-	01 Apr 1985

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ECTRIMS2023	Not Applicable	First line	560	Interferon beta-1a	nywrfustrr(rkntfzkwaw) = pegwsleqpn bxosfwzirm (eawwriexlt )	-	30 Sep 2023
PRIMA (ECTRIMS2022)	Not Applicable	-	426	Peginterferon beta-1a	mrwriobbim(yeybrxrmrp) = xwnxnfqphg hjiosseaih (bwgjlqpxfu ) View more	-	12 Oct 2022
				Intramuscular IFNβ-1a	mrwriobbim(yeybrxrmrp) = lcwhxhdaxk hjiosseaih (bwgjlqpxfu ) View more
NCT02584829 (CTgov)	Phase 1/2	Merkel Cell Carcinoma	8	Laboratory Biomarker Analysis+Recombinant Interferon Beta+Avelumab+MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells (Group 2 (Avelumab, MHC Class I Up-regulation, T Cells))	lwlyvhatvm(tmjloxwbmy) = xjlogbaqai jsdnvrrssd (nuloupgzut, thjbnvqlst - mskvjedeoy) View more	-	22 Mar 2022
				Laboratory Biomarker Analysis+Recombinant Interferon Beta+Avelumab (Group 1 (Avelumab and MHC Class I Up-regulation))	ywqazduzwj(fxropaffky) = tonsqymcme dbvrnvrfgp (rydidvxbsk, kzlqvqkuot - dodygnbwml) View more
ECTRIMS2021	Not Applicable	Multiple Sclerosis	850	Betaferon®/Extavia®	qjyidvkist(qkercddagr): HR = 3.28 (95% CI, 2.11 - 5.12)	Positive	12 Oct 2021
				Avonex®
ECTRIMS2020	Not Applicable	interferon-β	212	interferon-beta	zxpmfqiktu(gidmxphwyf) = dxivbwesvm lcsyssiakm (epwcfejquh ) View more	-	07 Dec 2020
				interferon-beta	zxpmfqiktu(gidmxphwyf) = prjrxcjrak lcsyssiakm (epwcfejquh ) View more
ECTRIMS2019	Not Applicable	interferon-beta	-	IFNβ-exposed	kixragkfcr(slhajnkxzu) = zdavhnijod osfbappmcc (asjgqjxpja, 0.2 - 1.7) View more	Positive	10 Sep 2019
				interferon beta	kixragkfcr(slhajnkxzu) = homneawtmh osfbappmcc (asjgqjxpja, 0.4 - 1.5) View more
European Interferon Beta Pregnancy Registry and MS Preg study (AAN2019)	Not Applicable	IFNβ	-	IFNβ-exposed pregnancies	iymnmnrcqx(ampolhubhe) = pvnuvhczfm tvouikfrip (bwssdncyea ) View more	Positive	09 Apr 2019
				Interferon Beta	iymnmnrcqx(ampolhubhe) = rhfktnajfh tvouikfrip (bwssdncyea ) View more
European Interferon Beta Pregnancy Registry (ECTRIMS2018)	Not Applicable	Pregnancy IFNβ	948	IFNβ exposure before conception and/or during pregnancy	vbuhmpnkah(gpzogerwtr) = nxpnqdrefl gkzcaymbpx (gfrbdkewiv ) View more	Positive	09 Oct 2018
				interferon beta	vbuhmpnkah(gpzogerwtr) = apacdoyvfl gkzcaymbpx (gfrbdkewiv ) View more
ECTRIMS2018	Not Applicable	Multiple Sclerosis	663	Glatiramer acetate	gygtbglucp(lcupvwzrev) = By the time of this analysis, no congenital malformations were reported rgjjsxowzf (hhogvckliy ) View more	Positive	09 Oct 2018
				Interferon beta
ARVO2018	Not Applicable	Glaucoma Interferon beta \| Erythropoietin -	-	interferon beta	rtptlcyege(qmyorlzkzv) = -3.7 fold lower qpaykrsacd (jpeexiwunp ) View more	-	01 Jul 2018
				interferon beta

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