Last update 01 Jul 2024

Remdesivir

Last update 01 Jul 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryRemdesivir,also known by its trade name VEKLURY®,is a RNA-dependent RNA polymerase (RdRp) inhibitor developed by Gilead Sciences it was first approved by PMDA in Japan on May 7th, 2020, followed by EMA in the European Union on July 3rd, 2020, and then by FDA in US on October 22nd, 2020. indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients who are hospitalized or not hospitalized but at high risk for progression to severe COVID-19, including hospitalization or death, and are at least 28 days of age and weigh at least 3 kg. The drug is intended to inhibit the replication of the SARS-CoV-2 virus by interfering with its ability to make copies of itself, thus reducing the severity of the disease.

Drug Type

Small molecule drug

Synonyms

Captisol-enabled remdesivir, Redyx, Remdesivir (JAN/USAN)

+ [4]

Target

RdRp

Mechanism

RdRp inhibitors(RNA-directed RNA polymerase inhibitors)

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

COVID-19

Inactive Indication

Hemorrhagic Fever, Ebola

Originator Organization

Gilead Sciences, Inc.

Active Organization

Gilead Sciences Ireland UC

Gilead Sciences, Inc.

Gilead Sciences Korea Ltd.

Inactive Organization

Capital Medical University

Drug Highest PhaseApproved

First Approval Date

JP (07 May 2020),

COVID-19

RegulationFast Track (US), Orphan Drug (US), Emergency Use Authorization (US)

Structure

Molecular FormulaC27H35N6O8P

InChIKeyRWWYLEGWBNMMLJ-YSOARWBDSA-N

CAS Registry1809249-37-3

Clinical Trials associated with Remdesivir

NCT05911906 / Not yet recruitingPhase 4IIT

An Open-label, Clinical Feasibility Study of the Efficacy of Remdesivir for Long-COVID.

Following an infection with Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV2), one in ten people will experience persisting symptoms, or develop symptoms which can last for months and even years. These symptoms affect people in different ways and have been demonstrated to broadly impact physical, mental, and cognitive health. This is called Long COVID. Currently, there are no treatments available to address the issues that patients experience but anti-viral medications have been suggested as being potentially effective. This study will recruit patients that have confirmed long COVID and participants will undertake a series of tests to determine their symptoms and the impact that their condition has had on their bodily systems. The total duration of each participant's involvement is approximately 8 weeks, and this will involve 13 visits (15 visits if taking part in Exeter) at the closest study location (Derby or Exeter). Initial assessments are conducted over three separate visits and then all participants will be scheduled to receive five consecutive days of a medication that has been identified as having the potential to reduce the impact of Long COVID. Following a period of 28 days, participants will be invited to repeat the same tests that were conducted before receiving the medication so that it can be determined how well the drug has worked. In this study we are specifically collecting information to understand how feasible this medication could be to help patients improve their condition and this will help us to determine how likely this drug is able to be used within the wider Long COVID community.
The medication that will be used within this study is an existing anti-viral medication (Remdesivir). If we find patients are able to tolerate the treatment and the research tasks we will use this information to conduct a larger trial to determine how well this drug can be used to reduce the impact of Long COVID in a greater number of patients.

Start Date01 Jun 2024

Sponsor / Collaborator

University of Derby

[+2]

CTRI/2023/04/052008 / Not yet recruitingPhase 4

A Multicenter, Open-label, Single-arm, Post Approval for Restricted use under Emergency Situation Study, to Evaluate the Safety and Efficacy of Injection Remdesivir 100mg (Lyophilized) Manufactured by Syngene International limited in Patients with Corona Virus Disease 2019.

Start Date05 May 2023

Sponsor / Collaborator

Syngene International Ltd.

[+1]

NCT05587894 / RecruitingPhase 2IIT

OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial: the OPTICOV Study

The overall purpose of the trial is to evaluate the efficacy and safety of possible combination antiviral therapy DAA (remdesivir + nirmatrelvir/r)∞ versus the reference monotherapy (nirmatrelvir/r alone) and to assess the efficacy and safety of increasing the nirmatrelvir/r course from 5- to 10 days in immunocompromised patients diagnosed with asymptomatic or mild to moderate COVID-19.

Start Date27 Apr 2023

Sponsor / Collaborator

ANRS, Emerging Infectious Diseases

[+1]

100 Clinical Results associated with Remdesivir

100 Translational Medicine associated with Remdesivir

100 Patents (Medical) associated with Remdesivir

3,564

Literatures (Medical) associated with Remdesivir

01 Aug 2024·Recent advances in anti-infective drug discovery

Outpatient Intravenous Remdesivir to Prevent Progression to Severe COVID-19: An Observational Study from a Greek Hospital

Article

Author: Kintrilis, Nikolaos ; Galinos, Iosif

Background::

Remdesivir, a viral RNA polymerase inhibitor, has been a powerful weapon in the battle against the SARS-CoV-2 pandemic. Originally approved for use in hospitalized patients, remdesivir improves clinical outcomes in patients with moderate to severe coronavirus disease 2019 (COVID-19). After proving efficacious in hospitalized patients, its use was approved in early disease for symptomatic, non-hospitalized patients that present risk factors for progression to severe disease.

Objective::

To evaluate whether administration of the antiviral medication remdesivir at an outpatient basis has an effect on hospital admissions of patients presenting with SARSCoV- 2 infection.

Methods::

We conducted an observational clinical trial involving 107 non-hospitalized COVID-19 patients who attended the emergency department of a third-level greek hospital seeking care for symptoms appearing within the previous 5 days and who had at least one risk factor for progression to severe disease. After arterial blood gas evaluation, eligible patients received intravenous remdesivir at a dose of 200 mg on day 1 and 100 mg on days 2 and 3. The efficacy endpoint was set as COVID-19-related hospitalization or death in the next 14 days.

Results::

A total of 107 patients (57.0% men) participated in the study, 51 (47.7%) of them fully vaccinated. Most prevalent were age ≥ 60 years old, cardiovascular/cerebrovascular disease, immunosuppression or malignancy, obesity, diabetes mellitus, and chronic lung disease. All patients enrolled completed the 3-day course, with a total of 3 out of 107 patients (2.8%) eventually having a COVID-19-related hospitalization by day 14, while no deaths were reported by day 14.

Conclusion::

Among non-hospitalized patients with at least one risk factor for progression to severe COVID-19, a 3-day course of intravenous remdesivir yielded favourable results.

01 Mar 2024·The American journal of emergency medicine

Association between patient-reported onset-to-door time and mortality in patients hospitalized with COVID-19 disease

Article

Author: Yadav, Kuldeep N ; Delgado, M Kit ; Snider, Christopher K ; Childs, Maya ; Patel, Arjun ; Hemmons, Jessica

INTRODUCTION:

Timely hospital presentation and treatment are critical for recovery from coronavirus disease (COVID-19). However, the relationship between symptom onset-to-door time and key clinical outcomes, such as inpatient mortality, has been poorly understood due to the difficulty of retrospectively measuring symptom onset in observational data. This study examines the association between patient-reported symptom onset-to-door time (ODT) and mortality among patients hospitalized and treated for COVID-19 disease.

METHODS:

We conducted a retrospective cohort study of emergency department (ED) encounters of patients with COVID-19 disease who were hospitalized and received remdesivir and/or dexamethasone between March 1, 2020, and March 1, 2022. The exposure was patient-reported ODT in days. The outcome of interest was inpatient mortality, including referral to hospice care. We used multivariable logistic regression to examine the association between ODT and mortality while adjusting for patient characteristics, hospital sites, and seasonality. We tested whether severe illness on hospital presentation modified the association between ODT and mortality. Severe illness was defined by Emergency Severity Index triage level 1 or 2 and hypoxia (SpO₂ < 94%).

RESULTS:

Of the 3451 ED hospitalizations included, 439 (12.7%) resulted in mortality, and 1693 (49.1%) involved patients with severe illness on hospital presentation. Greater ODT was significantly associated with lower odds of inpatient mortality (adjusted odds ratio (AOR) = 0.96, 95% CI = 0.93-1.00, P = 0.023). There was a statistically significant interaction between ODT and severe illness at hospital arrival on mortality, suggesting the negative association between ODT and mortality specifically pertained to patients who were not severely ill upon ED presentation (AOR = 0.93, 95% CI = 0.87-1.00, P = 0.035). The adjusted probability of mortality was significantly lower for non-severely ill, hospitalized patients who presented on days 8-14 (5.2%-3.3%) versus days 0-3 (9.4%-7.5%) after symptom onset.

CONCLUSION:

More days between symptom onset and hospital arrival were associated with lower mortality among hospitalized patients treated for COVID-19 disease, particularly if they did not have severe illness at ED presentation. However, onset-to-door time was not associated with mortality among hospitalized patients with severe illness at ED presentation. Collectively, these results suggest that non-severely ill COVID-19 patients who require hospitalization are less likely to decompensate with each passing day without severe illness. These findings may continue to guide clinical care delivery for hospitalized COVID-19 patients.

19 Feb 2024·ACS applied bio materials

Targeting RdRp of SARS-CoV-2 with De Novo Molecule Generation

Review

Author: Sreyas Adury, Venkata Sai ; Vijay, Amal ; Mukherjee, Arnab

Viruses are known for their extremely high mutation rates, allowing them to evade both the human immune system and many forms of standard medicine. Despite this, the RNA dependent RNA polymerase (RdRp) of the RNA viruses has been largely conserved, and any significant mutation of this protein is unlikely. The recent COVID-19 pandemic presents a need for therapeutics. We have designed a de novo drug design algorithm that generates strong binding ligands from scratch, based on only the structure of the target protein's receptor. In this paper, we applied our method to target SARS-CoV-2 RdRp and generated several de novo molecules. We then chose some drug molecules based on the structural similarity to some of our strongest binding de novo molecules. Subsequently, we showed, using rigorous all-atom explicit-water free energy calculations in near-microsecond time scales using state-of-the-art well-tempered metadynamics simulations, that some of our de novo generated ligands bind more strongly to RdRp than the recent FDA approved drug remdesivir in its active form, remdesivir triphosphate (RTP). We elucidated the binding mechanism for some of the top binders and compared it with RTP. We believe that this work will be useful both by presenting lead structures for RdRp inhibition and by delivering key insights into the residues of the protein potentially involved in the binding/unbinding of these small molecule drugs, leading to more targeted studies in the future.

379

News (Medical) associated with Remdesivir

27 Jun 2024

·www.biospace.com

Ligand Partner Verona Pharma Announces FDA Approval of Ohtuvayre™ (ensifentrine), First Inhaled Novel Mechanism for Maintenance Treatment of COPD in More Than 20 Years

FDA approval increases Ligand’s key commercial stage portfolio to 11 products Ligand is entitled to receive a low single-digit royalty on worldwide net sales of Ohtuvayre JUPITER, Fla.--(BUSINESS WIRE)-- Ligand Pharmaceuticals Inc. (Nasdaq: LGND) today announced that its partner Verona Pharma plc has received approval from the U.S. Food and Drug Administration (FDA) for Ohtuvayre™ (ensifentrine). Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients in more than 20 years. Ligand has earned a $5.8 million milestone payment upon FDA approval of Ohtuvayre and will earn an additional $13.8 million upon its commercial launch which is expected to occur during the third quarter of 2024. Ligand is entitled to a low single-digit royalty on worldwide net sales of Ohtuvayre. “Verona Pharma has worked tirelessly to bring a new treatment option to the millions of people managing chronic COPD and we are excited to see their efforts come to fruition with this approval,” said Todd Davis, CEO of Ligand. “For Ligand this is an important milestone, as it’s the second FDA approval within our royalty portfolio in two weeks and the eighth regulatory approval since 2023. COPD is a multi-billion-dollar market opportunity in the U.S. alone, and we believe Ohtuvayre will be another key growth driver for Ligand.” Ohtuvayre is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (“PDE3 and PDE4”) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. Ohtuvayre is delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination. With this FDA approval, Ligand now has 11 key commercial products driving the company’s financial performance and a portfolio of more than 100 additional programs at various stages of development. About OhtuvayreTM (ensifentrine) Ohtuvayre is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Verona has evaluated nebulized Ohtuvayre in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ohtuvayre met the primary endpoint in both ENHANCE-1 and ENHANCE-2, demonstrating statistically significant and clinically meaningful improvements in lung function. A fixed-dose combination of ensifentrine and glycopyrrolate, a LAMA, is currently under development for the maintenance treatment of COPD. Ensifentrine has potential applications for development in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. About COPD Chronic obstructive pulmonary disease (“COPD”) refers to a group of diseases that cause airflow blockage and breathing-related problems, such as emphysema and chronic bronchitis. More than 390 million people worldwide are living with COPD, and more than 8.6 million Americans are treated chronically1-2. Symptoms include increased shortness of breath, frequent coughing (with and without mucus), wheezing, tightness in the chest and unusual tiredness. Approximately 50% of COPD patients experience almost daily symptoms3. There is no cure for COPD and despite available treatment options, it is the third leading cause of death globally. 1Adeloye D, et al. Lancet Respir Med. 2022;10(5):447-458 2Verona IQVIA Ensifentrine Market Research 3Phreesia 2022 COPD Patient Survey About Ligand Pharmaceuticals Ligand is a biopharmaceutical company enabling scientific advancement through supporting the clinical development of high-value medicines. Ligand does this by providing financing, licensing our technologies or both. Its business model seeks to generate value for stockholders by creating a diversified portfolio of biopharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Ligand’s goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable and diversified manner. Its business model focuses on funding programs in mid- to late-stage drug development in return for economic rights, purchasing royalty rights in development stage or commercial biopharmaceutical products and licensing its technology to help partners discover and develop medicines. Ligand partners with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) in order to generate its revenue. Ligand’s Captisol® platform technology is a chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand has established multiple alliances, licenses and other business relationships with the world’s leading biopharmaceutical companies including Amgen, Merck, Pfizer, Jazz, Takeda, Gilead Sciences and Baxter International. For more information, please visit Follow Ligand on X @Ligand_LGND. We use our investor relations website and X as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. Investors should monitor our website and our X account, in addition to following our press releases, SEC filings, public conference calls and webcasts. Forward-Looking Statements This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. Words such as “plans,” “believes,” “expects,” “anticipates,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding: the timing of the anticipated commercial launch of Ohtuvayre by Verona and the potential contribution it is expected to bring to Ligand; the timing and amount of milestone payments Ligand expects; the potential royalties to be paid on sales of Ohtuvayre by Verona; and Ensifentrine’s other potential applications for development. Actual events or results may differ from Ligand’s or its partner’s expectations due to risks and uncertainties inherent in Ligand’s and its partner’s business, including, without limitation: Verona may not be able to successfully commercialize Ohtuvayre which will depend on a number of factors including coverage and reimbursement levels from governmental authorities and health insurers as well as market acceptance by healthcare providers; the market size for Ohtuvayre may be smaller than estimated; Ligand is dependent on Verona for the commercialization of Ohtuvayre; and other risks described in Ligand’s prior press releases and filings with the Securities and Exchange Commission available at . The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand’s stock price. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Phase 3Clinical ResultDrug ApprovalLicense out/in

24 Jun 2024

·www.biospace.com

A Novel Broad-Spectrum Antiviral Against Influenza A Viruses, NV-387, Could Be an Important Weapon to Fight Bird Flu H5N1, Says NanoViricides

SHELTON, CT / ACCESSWIRE / June 24, 2024 / NanoViricides, Inc. (NYSE Amer.:NNVC) (the "Company"), a clinical stage global leader in broad-spectrum antiviral nanomedicines, comments that the ultra-broad-spectrum antiviral NV-387 could be an important weapon against bird flu H5N1 viruses. NanoViricides has recently found that its host-mimetic clinical drug candidate NV-387 was substantially superior to the three approved drugs against influenza, namely Oseltamivir (Tamiflu®, Roche), Peramivir (Rapivab®, Biocryst), and Baloxavir (Xofluza®, Shionogi, Roche) in a lethal animal model study of Influenza A/H3N2 virus lung infection. Further, in this study, NV-387 was also found to protect the lungs of the infected animals from viral damage as well as immune system damage, supporting a strong antiviral effect. These results have arrived just as the bird flu H5N1 threat potential has increased significantly due to its spread into several mammalian species. While dairy cattle have suffered relatively mild infections, some other mammals, particularly cats on farms have died of brain infection with this virus. Only four human cases have occurred so far with one person dying in Mexico, while the three other cases all in the USA have recovered. NV-387 is anticipated to be a strong drug candidate that would remain effective against HPAI H5N1 even as significant mutations occur. This is because of two main reasons: The Multi-Basic Site (MBS) in the H5. All HPAI possess a MBS in the H5 which is highly positively charged. The MBS enables strong interaction with sulfated proteoglycans ("S-PG"). Since NV-387 is a host-mimetic of S-PG, it is expected that NV-387 would have a strong effect against the MBS-carrying HPAI H5N1. The broad-spectrum activity of NV-387. NV-387 is active against many very different viruses including Influenza A, RSV, COVID, Seasonal Coronaviruses, and even Poxviruses. This is because of its host-mimetic feature that copies the invariant attachment site common to all of these viruses, the S-PG. The HPAI H5N1 also uses S-PG for attachment, possibly more profoundly than H3N2, because of the MBS in HPAI. Thus NV-387 is likely to continue to work against the HPAI H5N1 despite mutations that cause resistance to other drugs. In contrast, very few single-point mutations could make the HPAI H5N1 virus resistant to the existing drugs. Only as few as five mutations in the HA (hemagglutinin) protein of this virus could enable it to gain the ability to efficiently infect humans, and this could lead to a pandemic with much greater fatality rates than with COVID, according to Dr. Redfield, ex-Director of CDC as reported in a NewsNation interview ( ). Bird Influenza viruses use a-2,3-sialic acid receptors whereas human influenza viruses use a-2,6-sialic acid receptors to gain entry into cells. Viruses typically concentrate at heparan sulfate or sulfated proteoglycans (S-PG) prior to gaining cell entry. Influenza viruses have a high rate of mutations, and further they can mix-and-match the eight segments of genome from other influenza viruses, called re-assortment, or pick portions of these segments, called recombination. A safe and effective antiviral drug that the virus would not escape by simple mutations or field evolution is the holy grail of antiviral drug development. We believe that the NanoViricides Platform technology meets this challenge. About NanoViricides NanoViricides, Inc. (the "Company") ( ) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-CoV-2 for the treatment of RSV, COVID-19, Long COVID, and other respiratory viral infections. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles (previously referred to as NV-HHV-101). The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-CoV-2 into Phase I/II human clinical trials. NV-CoV-2 is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-CoV-2 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently. The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for poxviruses and/or enteroviruses if the initial research is successful. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product. This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products. The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA. FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". Contact: NanoViricides, Inc. info@nanoviricides.com Public Relations Contact: MJ Clyburn TraDigital IR clyburn@tradigitalir.com SOURCE: NanoViricides, Inc. View the original press release on accesswire.com

License out/in

20 Jun 2024

·www.biospace.com

A Novel Broad-Spectrum Antiviral Against Influenza A Viruses, NV-387, Is Effective in Protecting Lungs from Damage in Lethally Infected Animal Model

SHELTON, CT / ACCESSWIRE / June 20, 2024 / NanoViricides, Inc. (NYSE AmerIcan.:NNVC) (the "Company"), a clinical stage company and global leader in broad-spectrum antiviral nanomedicines, reports that the ultra-broad-spectrum antiviral NV-387, a clinical Phase II stage drug candidate, was found to be effective in protecting lungs from damage in a lethally infected Influenza A H3N2 mouse model. "We believe that the lung protection afforded by NV-387 is a very important result. The most severe cases that lead to hospitalization and fatalities in respiratory viral infections involve lung damage as an important factor," said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, "This was starkly evidenced during COVID-19 pandemic wherein the Delta variant that caused severe lung damage also caused the largest number of hospitalizations and fatalities. Influenzas, RSV, COVID can all cause severe lung damage resulting in fatalities." 1. NV-387 Treatment Resulted in Significant Reduction in Lung Infiltration and Lung Cell Death Lungs of infected animals treated with NV-387, orally or intravenously, showed very limited presence of infiltrating cell-killing immune cells that are known to be an important cause of lung damage, in addition to the direct lung damage from infected cell death caused by the virus itself. Further, the overall lung damage was significantly reduced upon NV-387 treatment. On day 7 post-infection, NV-387 oral treatment resulted in only about 31% lung infiltration by immune system cells, and NV-387 intravenous treatment resulted in an even lower, about 22%, infiltration rate, whereas the lungs of infected untreated animals had a very high 68% infiltration rate (smaller is better), as determined by micro-histopathology of lung tissues using specific staining techniques. 2. NV-387 Treatment Resulted in Significant Reduction in Mucus Load in the Lungs Additionally, the extent of mucus in the lung tissue was substantially reduced in the case of oral as well as intravenous NV-387 treatment. The mucus index value in the case of NV-387 oral treatment was about 53, and for intravenous NV-387 treatment it was about 32, as compared to the infected untreated animals that had a mucus index value of 138 (smaller is better). Mucus is secreted by secretory cells in response to viral infection in an attempt to clear the virus, but it results in reduced lung capacity and eventually can lead to pneumonia. Thus reduction in mucus load is an important sign that the progress of the viral infection is arrested. NV-387 Treatment Significantly Protected Lungs of Balb-c Mice Lethally Infected with Influenza A/H3N2 Virus Treatment Lung Mucus Index % Immune Cell Infiltration NV-387, Intravenous 32 22% NV-387, Oral 53 31% Untreated Infected Control 138 68% These results indicate that NV-387 treatment led to a significant level of protection of lungs in Balb-c mice lethally infected with Influenza A H3N2 virus. 3. NV-387 Treatment Resulted in Significantly Greater Survival Improvement Compared to Three Approved Influenza Drugs Previously, we reported from this same animal study that NV-387 treatment led to substantially longer animal survival compared to the three approved influenza drugs, namely Oseltamivir (Tamiflu ®, Roche), Rapivab (Peramivir, BioCryst), and Baloxavir (Xofluza®, Shionogi, Roche). NV-387 treatment, both intravenous and oral, led to increase in survival of animals by a substantial 88% over the infected untreated controls, whereas the three approved drugs only increased survival marginally, by about 25% to 38%. These results indicate that NV-387 was substantially superior to the three approved influenza drugs in this animal study. The above results demonstrate that NV-387 possesses strong antiviral activity against Influenza viruses. 4. Viral Resistance to NV-387 is Unlikely as Opposed to Known Evolution of Viral Resistance Against Currently Approved Drugs Baloxavir resistant mutants were found to develop in as many as 10% of treated patients in its Phase III clinical trials. Oseltamivir resistant mutants are known and circulating, and they exhibit resistance to Peramivir as well. In contrast, even as influenza viruses mutate, they would be highly unlikely to escape NV-387. This is because NV-387 is an ultra broad-spectrum antiviral that is designed as a host-mimetic (See paragraph (a) below). 5. NV-387 Has Completed Phase I Human Clinical Trial There were no reported adverse events, and there were no dropouts in the Phase I human clinical trial of NV-387, indicative of excellent safety and tolerability of NV-387. This drug candidate is thus ready for further development in Phase II clinical trials. In summary, NV-387 is poised to become a very important drug in the fight against Influenza viruses, we believe. (a). Host-Mimetic Nanoviricide Drug Candidate NV-387 is Designed to Attack Many Viruses; with Escape of Virus Unlikely All influenza viruses bind to the host's sulfated proteoglycans ("S-PG") as primary attachment receptors and cellular sialic acids as cognate receptors; the latter enabling entry into cells. NV-387 is designed to copy the invariant or conserved features of S-PG and present itself like a human cell decoy to the virus. As the virus binds to the NV-387 metamorphic ("shape-shifter") micelle, the NV-387 polymer chains are expected to wrap onto the virus surface, via a well known process called "lipid-lipid fusion", merging the lipid chains of the NV-387 polymer with the lipid coat of the virus particle. This is expected to result in destabilization of the virus, uprooting the H and N proteins from the virus surface, thereby making the virus incapable of attacking human cells. A safe and effective antiviral drug that the virus would not escape by simple mutations or field evolution is the holy grail of antiviral drug development. We believe that the NanoViricides Platform technology meets this challenge. About NanoViricides NanoViricides, Inc. (the "Company") ( ) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-CoV-2 for the treatment of RSV, COVID-19, Long COVID, and other respiratory viral infections. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles (previously referred to as NV-HHV-101). The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-CoV-2 into Phase I/II human clinical trials. NV-CoV-2 is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-CoV-2 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently. The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for poxviruses and/or enteroviruses if the initial research is successful. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product. This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products. The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA. FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". Contact: NanoViricides, Inc. info@nanoviricides.com Public Relations Contact: MJ Clyburn TraDigital IR clyburn@tradigitalir.com SOURCE: NanoViricides, Inc. View the original press release on accesswire.com

Clinical ResultPhase 2Phase 1License out/inPhase 3

100 Deals associated with Remdesivir

External Link

KEGG	Wiki	ATC	Drug Bank
D11472	Remdesivir	J05AB	DB14761

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
COVID-19	JP	Gilead Sciences, Inc.	07 May 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hemorrhagic Fever, Ebola	Phase 2	GN	Gilead Sciences, Inc.	01 Jul 2016
Hemorrhagic Fever, Ebola	Phase 2	LR	Gilead Sciences, Inc.	01 Jul 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04431453 (CARAVAN, CTgov)	Phase 2/3	COVID-19	59	Remdesivir (Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg)	bysdonhwzn(yqvvgizpnt) = stfbeyjjlj mumqyytmbg (gssrrqcxua, yskogoylet - vxbzubnfsg) View more	-	22 Dec 2023
				Remdesivir (RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg)	bysdonhwzn(yqvvgizpnt) = vdtxvwxwhv mumqyytmbg (gssrrqcxua, mnzwchdnxr - mxnsjkovbt) View more
ERA2023	Not Applicable	Maintenance	201	Remdesivir	ccxzhhpbey(kavwnvqhjq) = yvmuaubguj uagzblgmam (pqcvyqhncn, 11 - 24)	-	15 Jun 2023
				REMDESIVIR (Standard-of-care)	ccxzhhpbey(kavwnvqhjq) = ggeorxjdlc uagzblgmam (pqcvyqhncn, 16 - 31)
NCT04391309 (CTgov)	Phase 2	COVID-19 \| Severe Acute Respiratory Syndrome	49	IC14+remdesivir (IC14)	rbqihxwuuv(cckikutzak) = amvorlipsn doupkfoowh (yhawectwer, jnkgicnmme - mdezzugien) View more	-	15 Jun 2023
				remdesivir+Sodium Chloride (Placebo)	rbqihxwuuv(cckikutzak) = mryfjpmyml doupkfoowh (yhawectwer, wehfkzolwk - cgzxhbaudi) View more
NCT04988035 (CTgov)	Phase 2	COVID-19	201	Danicopan+Remdesivir (Remdesivir + Danicopan)	puhydbofbk(ntjsetucrs): Odds Ratio (OR) = 0.64 (95% CI, 0.38 - 1.07), P-Value = 0.090 View more	-	08 Jun 2023
				Placebo+Remdesivir (Remdesivir + Placebo)
NCT04583969 (ACTIV-5/BET-B, CTgov)	Phase 2	COVID-19	527	Lenzilumab+Remdesivir (Remdesivir + Lenzilumab)	csfojwrfkp(rdrzdbobre) = lmppmoveor imlrlfhxvc (xsiquglhce, vxjcgedtqg - cewxalorsq) View more	-	05 Jun 2023
				Placebo+Remdesivir (Remdesivir + Placebo)	csfojwrfkp(rdrzdbobre) = pajappnsul imlrlfhxvc (xsiquglhce, vwtkmnwfhq - wtbokenxmm) View more
NCT04745351 (CTgov)	Phase 3	COVID-19	249	Standard of Care+Remdesivir (Remdesivir (RDV))	bfscrsmwvy(buspjrbjoc) = gmofpaezzq qnjjwetyvg (qmywwladhp, orkwuigxer - ivtjzqbaia) View more	-	12 May 2023
				Standard of Care (Placebo)	bfscrsmwvy(buspjrbjoc) = mqelncmbky qnjjwetyvg (qmywwladhp, amyutkryts - tgemxrorol) View more
NCT04593940 (CTgov)	Phase 3	COVID-19	1,971	Infliximab (Standard of Care + Infliximab)	toneavfsiv(bkvgkgkbud) = upelhyrakr nqrlvkgmko (aofzdrekik, rqfgbumopk - ddqwilyzrb) View more	-	21 Apr 2023
				Placebo (Standard of Care + Infliximab Matching Placebo)	toneavfsiv(bkvgkgkbud) = jjlmimbpjj nqrlvkgmko (aofzdrekik, suhuulhkbf - epejuvntri) View more
NCT05502081 (CTgov)	Phase 4	COVID-19	265	Casirivimab+Imdevimab (Casirivimab and Imdevimab)	cxrhovsoee(vvxtgkvyvf): P-Value = <0.001 View more	-	21 Feb 2023
				Remdesivir (Remdesivir)
Pubmed	Not Applicable	COVID-19	-	Remdesivir	jovbntorsk(rnrbfcxsbx): RR = 0.93 (95% CI, 0.81 - 1.06) View more	-	25 Jan 2023
				Remdesivir (Standard care plus/minus placebo)
NCT04583956 (CTgov)	Phase 2	COVID-19	214	Risankizumab+Remdesivir (Remdesivir + Risankizumab)	wtrwqojkcb(lmzddhppuu): Odds Ratio (OR) = 0.98 (95% CI, 0.59 - 1.61), P-Value = 0.927 View more	-	19 Dec 2022
				Placebo+Remdesivir (Remdesivir + Placebo)

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis