A Double-blind, Randomized, Phase 2 Study to Investigate the Efficacy, Tolerability and Pharmacokinetics of MYMD1 in the Treatment of Participants Aged 65 Years or Older With Chronic Inflammation Associated With Sarcopenia/Frailty

The study will be conducted to investigate the efficacy, tolerability and pharmacokinetics of MYMD1 in participants with chronic inflammation associated with sarcopenia/frailty, a condition linked to elevated levels of proinflammatory cytokines.

Start Date01 Feb 2022

Sponsor / Collaborator

TNF Pharmaceuticals, Inc.

NCT05077865 / CompletedPhase 1

A Double-blind, Placebo-controlled, Randomized, Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Oral Dose of MYMD1 Capsules in Healthy Male and Female Adult Subjects

Double-blind, placebo-controlled, single ascending and multiple dose study. Approximately 32 healthy adult male and female subjects will be given a single capsule of MYMD1 to determine its safety, tolerability, and pharmacokinetic properties. The study data will guide the establishment of an optimum therapeutic dose.

Start Date26 Apr 2021

Sponsor / Collaborator

TNF Pharmaceuticals, Inc.

NCT04349761 / CompletedPhase 1

A Double-blind, Placebo-controlled, Randomized, First-in-human, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Oral Dose of MYMD1 Capsules in Healthy Male Adult Subjects

Double-blind, placebo-controlled, First-in-Human, single ascending-dose study. Approximately 40 healthy adult male subjects will be given a single capsule of MYMD1 to determine its safety, how well it is tolerated, how the body acts on the experimental drug, and how the experimental drug acts on the body. This will be based on blood and urine sample analysis and other physical measurements.

Start Date11 Jun 2019

Sponsor / Collaborator

TNF Pharmaceuticals, Inc.

100 Clinical Results associated with Isomyosamine

100 Translational Medicine associated with Isomyosamine

100 Patents (Medical) associated with Isomyosamine

Literatures (Medical) associated with Isomyosamine

24 Feb 2023·The journals of gerontology. Series A, Biological sciences and medical sciences

MyMD-1 Improves Health Span and Prolongs Life Span in Old Mice: A Noninferiority Study to Rapamycin

Article

Author: Sabini, Elena ; O’Mahony, Alison ; Caturegli, Patrizio

Abstract:

Aging and age-related diseases represent a compelling therapeutic goal for senolytics and drugs targeting inflammatory or metabolic pathways. We compared MyMD-1, a synthetic derivative of the alkaloid myosmine capable of suppressing TNF-α production, to rapamycin, the best characterized drug endowed with antiaging properties. In vivo, a longitudinal cohort of 54 C57BL/6 mice, 19-month-old at the start, was randomized to receive MyMD-1, high-dose (126 ppm) rapamycin, or low-dose (14 ppm) rapamycin plus metformin. Each treatment arm included 18 mice (10 females and 8 males) and was followed for 16 months or until death. Life span was significantly longer in MyMD-1 than rapamycin (p = .019 vs high-dose and .01 vs low-dose) in a Cox survival model that accounted for sex and serum levels of IL-6, TNF-α, and IL-17A. MyMD-1 also improved several health span characteristics, resulting in milder body weight loss, greater muscle strength, and slower progression to frailty. In vitro, MyMD-1 and rapamycin were compared using a panel of 12 human primary cell systems (BioMAP Diversity PLUS), where a total of 148 biomarkers were measured. MyMD-1 possessed antiproliferative, anti-inflammatory, and antifibrotic properties. Many were shared with rapamycin, but MyMD-1 was more active in the inhibition of proinflammatory and profibrotic biomarkers. Overall, MyMD-1 emerges as a new compound that, even when begun at an advanced age, induces beneficial effects on health and life span by modulating inflammation and tissue remodeling.

01 Feb 2023·Drug research

A Double-blind, Placebo-controlled, Randomized, Single Ascending, and Multiple Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Dose Isomyosamine Capsules in Healthy Adult Subjects

Article

Author: Brager, Jenna ; Kaplin, Adam ; Dunn, Leonard ; Chapman, Chris

Abstract:

Background Aging is tightly linked to chronic disease, frailty, and death. Multi-morbidity, defined as the presence in the same patient of three or more conditions such as neoplastic, cardiovascular, neurodegenerative, metabolic, or autoimmune diseases, becomes more common with age. Methods The study was performed in a double-blind fashion. Subjects within each dose cohort (Cohorts 1, 2, 3, and 4) were randomly assigned to receive Isomyosamine doses (between 150 mg to 600 mg or placebo) or placebo in a 3:1 ratio (6 active: 2 placebo). Results Isomyosamine single daily doses each of 150 mg, 300 mg, and 450 mg for 3 days and multiple daily doses of 600 mg for 6 days were safe and well tolerated in healthy subjects. In one dose group, there was a decrease in TNF-α levels found in Isomyosamine treated subjects, but no change in the levels in subjects given placebo. The increase in Isomyosamine exposure was proportional to dose across the dose range of 300 mg to 600 mg when administered as a single dose. There was minimal accumulation of Isomyosamine following 5 days of once daily dosing of Isomyosamine 600 mg. Isomyosamine half-life ranged from approximately 15 minutes to 45 minutes across all doses in the single ascending dose and multiple ascending dose portion of the study. Elimination of Isomyosamine included the renal pathway as a minor route. Conclusion Isomyosamine will continue to be investigated in phase 2 clinical trials for the treatment of sarcopenia/frailty, hashimoto’s thyroiditis and rheumatoid arthritis.

01 Feb 2020·Journal of neuroimmunologyQ3 · MEDICINE

MYMD-1, a novel alkaloid compound, ameliorates the course of experimental autoimmune encephalomyelitis

Q3 · MEDICINE

Article

Author: Glenn, Justin D ; Pantoja, Itzy Morales ; Caturegli, Patrizio ; Whartenby, Katharine A

Multiple sclerosis (MS) is an autoimmune disease that remains in need of effective therapies. Plant-derived medicines have appealing properties for the treatment of autoimmune diseases. MYMD-1 is a synthetic plant alkaloid that has been shown to ameliorate the course of autoimmune thyroiditis. The goal of the present study was to determine whether MYMD-1 would produce similar beneficial effects in a mouse model of MS, experimental autoimmune encephalomyelitis (EAE) induced by immunization with myelin oligodendrocyte glycoprotein. MYMD-1 improved the course of EAE and suppressed activation of effector T cells without causing global immunosuppression or toxicity. These results suggest that MYMD-1 may be of interest for evaluating for the treatment of autoimmune diseases.

News (Medical) associated with Isomyosamine

21 Aug 2024

·www.businesswire.com

TNF Pharmaceuticals Prepares to Advance Lead Clinical Program Targeting Age-Related Decline

BALTIMORE--( BUSINESS WIRE )--TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNFA” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for age-related diseases, and autoimmune and inflammatory conditions, today announced that it is preparing to advance its lead program, MYMD-1®, through fully funded mid-stage clinical trials. MYMD-1 is a small molecule shown to block excessive activity of TNF-alpha (TNF-α) in the blood to regulate the immuno-metabolic system. The next clinical studies of MYMD-1 will further explore the drug’s efficacy in sarcopenia/frailty following statistically significant positive results from an earlier Phase 2 clinical study. “In our view, MYMD-1, if approved, could be the first orally administered TNF-alpha inhibitor drug and the first and only therapy for sarcopenia, a common age-related disorder that causes a prolonged decline in physical function. The success of our clinical strategy and regulatory pathway to date supports MYMD-1’s potential to disrupt the TNF-alpha inhibitor market,” said Mitchell Glass, M.D., President and Chief Medical Officer of TNF Pharmaceuticals. “As we prepare for our next fully funded clinical studies in sarcopenia/frailty, we also have open INDs for Phase 2 trials of MYMD-1 in two additional chronic inflammatory conditions, rheumatoid arthritis (RA) and Hashimoto’s thyroiditis, which we could pursue with the support of non-dilutive domestic and/or international development partnerships. A partner outside of the U.S. could potentially help us accelerate the timeline to commercialization of our lead asset. “Each of MYMD-1’s indications provide solid measures of Company value,” Dr. Glass continued. “We are excited about the positive data we have gathered so far for our lead asset. Our next steps, to be revealed soon, will extend our reach toward significant and sustainable value creation, and long-term Company growth.” MYMD-1 Phase 2 Clinical Development MYMD-1 targets TNF-alpha (TNF-alpha tumor necrosis factor-alpha, or TNF-α), a protein in the body that plays a key role in inflammation and autoimmunity. Sarcopenia. A small Phase 2 study, completed in 2023, investigated the efficacy, tolerability and pharmacokinetics of MYMD-1 in the treatment of participants with chronic inflammation associated with sarcopenia/frailty. The study met its primary endpoints for significantly reducing chronic inflammatory markers with statistically significant results. MYMD-1 significantly reduced serum levels of chronic inflammatory markers and met all primary pharmacokinetic and secondary safety and tolerability endpoints. MYMD-1 demonstrated statistical significance across three biomarkers: TNF-α (P=0.008), sTNFR1 (P=0.02), and IL-6 (P=0.03). No treatment-related adverse events (AEs) or serious adverse events (SAEs) occurred over the course of the study. Sarcopenia, the aging-related progressive loss of muscle mass and strength in older people and in a growing population of younger people, is a condition which leads to greater risk of hospitalization, disability, and death. With no FDA-approved treatments for sarcopenia, the estimated $40+ billion in related hospitalization costs is a considerable economic burden on the U.S. healthcare system. 1 Rheumatoid arthritis (RA) . An Investigational New Drug (IND) application for a Phase 2 study of MYMD-1 in RA was reviewed and approved by the FDA in August 2023. MYMD-1’s small molecule design enables the drug to cross the blood brain barrier for entry into the central nervous system. In a preclinical trial, MYMD-1 was shown to significantly reduce swelling and other clinical arthritis measures compared to the widely used RA therapy Enbrel® (etanercept). 2 Disease severity (total composite score) was reduced by 47% with MYMD-1 (450 mg/kg/day orally) versus a 37% reduction with etanercept (10 mg/kg by subcutaneous injection). RA is a chronic, systemic inflammatory disorder that causes chronic inflammation of the joints and affects approximately 1.5 million Americans. RA’s cost to society, including healthcare costs; loss of employment; costs to employers, government, and caregivers; and costs associated with a deterioration of quality of life, is estimated to be over $40 billion annually. 3 Hashimoto’s thyroiditis. MYMD holds an FDA-cleared IND for a Phase 2 pilot study of MYMD-1 for Hashimoto’s thyroiditis, a condition in which the immune system stops recognizing the thyroid as part of the body and begins attacking it. Hashimoto’s thyroiditis is the most common cause of hypothyroidism in the United States. 4 According to an American Thyroid Association report, approximately 12% of the U.S. population will develop a thyroid condition during their lifetime and an approximate amount of 20 million Americans are diagnosed with some form of thyroid disease during their lifetime. 5 The global thyroid gland disorder market was valued at $2.1 billion in 2017, and is estimated to reach $2.7 billion by 2025 at a CAGR of 3.8% from 2018 to 2025. 6 Secondary Drug Platform — Supera-CBD ™ TNFA’s secondary drug platform, Supera-CBD ™ , is a synthetic, non-toxic cannabidiol (CBD) analog that is an 8000-times more potent CB2 agonist than plant-based CBD. 7 Supera-CBD is targeted for the treatment of epilepsy, pain and anxiety/depression. Based on an in vitro binding analysis of Supera-CBD with three types of opioid receptors, the profile suggests that Supera-CBD could play a role in treating opioid addiction. About TNF Pharmaceuticals, Inc. TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (formerly known as MyMD Pharmaceuticals, Inc.), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1® is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.tnfpharma.com . Cautionary Statement Regarding Forward-Looking Statements This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed by the Company on April 1, 2024, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise. 1 Journal of Frailty & Aging, Economic Impact of Hospitalizations in US Adults with Sarcopenia (2019) 2 ENBREL ETANERCEPT is a registered trademark of Immunex Corporation 3 https://reporter.nih.gov/project-details/10080141 4 Taylor N Peter et al. Global epidemiology of hyperthyroidism and hypothyroidism. Nature: Endocrinology. 2018 May; 14:301-316. 5 American Thyroid Association. General Information/Press Room. Available in: https://www.thyroid.org/media-main/press-room/ 6 KUNSEL, Tenzin. Thyroid Gland Disorder Treatment Market. Allied Market Search, 2018. Available in: < https://www.alliedmarketresearch.com/thyroid-gland-disorder-treatment-market > 7 Company reports ; study conducted by Eurofins Discovery , a Eurofins Scientific (EUFI.PA) company

Phase 2Clinical Result

24 Jul 2024

·www.businesswire.com

TNF Pharmaceuticals (Formerly MyMD Pharmaceuticals) Begins Trading Under New Nasdaq Stock Symbol “TNFA” Effective Before Market Open Today

BALTIMORE--( BUSINESS WIRE )--TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (formerly MyMD Pharmaceuticals, Inc.) (the “Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for age-related diseases and autoimmune and inflammatory conditions, today announced that its common stock, listed on the Nasdaq Capital Market, begins trading under the new ticker symbol, “TNFA,” effective before the market open today, July 24, 2024. The new trading symbol “TNFA” replaces the Company’s previous trading symbol “MYMD” and coincides with the Company’s previously announced corporate name change to TNF Pharmaceuticals, Inc. The new corporate identity more accurately aligns with the Company’s scientific focus on TNF-alpha (TNF-alpha tumor necrosis factor-alpha, or TNF-α), a protein in the body that plays a key role in inflammation and autoimmunity. The Company’s lead clinical candidate, MYMD-1®, blocks the activity of excess TNF-α, which supports restoration of control and regulation of the immune system. “Our Company’s new name and stock identity comes at an important time in our clinical development of MYMD-1, illuminating both our core science and our clinical candidate’s strong potential to be the first TNF-α inhibitor in this indication,” said the Company’s President, Chief Medical Officer and Director, Mitchell Glass, M.D. Effective today, all stock trading, Securities and Exchange Commission filings and market-related information will be reported under the new trading symbol “TNFA.” The CUSIP for the Company's common stock is unchanged. There is no action required by the Company’s current stockholders with respect to the trading symbol change. About TNF Pharmaceuticals, Inc. TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), formerly known as MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1® is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.tnfpharma.com . Cautionary Statement Regarding Forward-Looking Statements This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed by the Company on April 1, 2024, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

23 Jul 2024

·www.fiercepharma.com

MyMD Pharmaceuticals is no more: Meet TNF Pharmaceuticals

The biotech is tapping the mechanism of action of its leading med for the name change. The life sciences industry continues to see a trend of rebranding as another biotech company decides to embrace change by saying goodbye to the old and welcoming the new. This time it’s anti-aging biotech MyMD Pharmaceuticals that is changing its name, corporate branding and logo, as it resets to TNF Pharmaceuticals. The name change is primarily based on the mechanism of action for its most advanced med, MYMD-1, which works as an TNF-alpha inhibitor. It will also change its stock symbol to “TNFA.” The ethos of the company and its main med is that excess TNF alpha in the blood or tissue can lead to diseases and disorders marked by acute or chronic inflammation, including age-related disorders. MYMD-1 works by blocking the activity of excess TNF-alpha which the company believes can help restore control and regulation of the immune system. The biotech has however endured a bumpy 12 months. Last July there was good news when its lead asset hit all primary and secondary endpoints in a mid-stage study of age-related inflammation sarcopenia, setting the company up to begin phase 3 talks with the FDA. But in February this year, the biotech was forced into a reverse stock split to maintain compliance on the Nasdaq amid a dwindling stock price. It did regain compliance but is now trading under $2 a share, massively down from the $56 a share it saw in August after its midstage data dropped. It also just last month saw a major change in its leadership, with board member Mitchell Glass, M.D., stepping into the president and chief medical officer role at the company, which the company said was to position itself better as it enters into late-stage trials.

Executive ChangePhase 3

100 Deals associated with Isomyosamine

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Hashimoto Disease	Phase 1	US	TNF Pharmaceuticals, Inc.	26 Apr 2021
Rheumatoid Arthritis	Preclinical	US	Charles River Laboratories, Inc.	20 Mar 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05283486 (Biospace) Manual	Phase 2	Sarcopenia	-	MYMD-1	acsiamqusk(fmxtaqmpfz): P-Value = 0.03 View more	Positive	31 Jul 2023
				placebo
Pubmed Manual	Phase 1	-	32	Isomyosamine Capsules (double-blind fashion)	dejjjkjesf(lcyhguybxw) = Isomyosamine half-life ranged from approximately 15 minutes to 45 minutes. gmipvlivjh (pyjwrixsbf )	Positive	11 Nov 2022
				Placebo (double-blind fashion)

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