MyMD Pharmaceuticals Announces Positive Clinical Data in Advance of Upcoming Phase 2 Trial of MYMD-1 for Extending Healthy Lifespan
08 Feb 2022
Small molecular drugCollaborate
MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage pharmaceutical company committed to extending healthy lifespan, today announced Phase 1 clinical trial data demonstrating MYMD-1’s reduction of tumor necrosis factor-alpha (TNF-α), the molecules that are the root cause of aging, in the blood of healthy human subjects.
In the Phase 1 study, subjects were treated with MYMD-1 or placebo and TNF-α levels were measured pre and post treatment. There was a statistically significant decrease in TNF-alpha levels (p-value <0.05) found in MYMD-1 treated subjects, but no change in the levels in subjects given placebo. While consistent with all of the preclinical studies of MYMD-1, this is the first demonstration in humans of the ability of MYMD-1 to decrease TNF-α levels.
Chris Chapman, M.D., President, Director and Chief Medical Officer of MyMD, stated, “We believe that our drug’s statistically significant reduction of TNF-α in the blood of healthy subjects is a great achievement in medicine because the TNF-α levels in this population were not elevated to begin with. Having demonstrated the drug’s mechanism of action and efficacy in Phase 1, we are pleased that the FDA has approved TNF-α reduction as the primary endpoint for our Phase 2 trial. MYMD-1’s oral delivery, selectivity, and low toxicity as compared with other TNF-α blockers, none of which are FDA-approved for aging, offers a distinctive drug pro we believe is vastly superior to any TNF-α blocker on the market today.”
MYMD-1’s Phase 1 aging data is consistent with outcomes from pre-clinical models pointing to the drug’s potential role in reducing both frailty and inflammatory cytokines. Details of the Phase 1 clinical trial design are available at clinicaltrials.gov.
MyMD has stated that there are no FDA-approved drugs for treating aging disorders and extending healthy lifespan in humans, a market expected to be at least $600 billion by 20251 according to a major investment bank. The U.S. Patent and Trademark Office (USPTO) issued U.S. Patent 11,179,382 B2, titled “Methods of Reversing Normal Aging Process and Extending Lifespan.” The allowed claims protect the use of MYMD-1 in a method designed to extend the lifespan of an individual.
TNF-α blockers are the most prescribed drugs by revenue, a global market of approximately $40 billion per year,2 and, according to Nature Aging journal,3 a slowdown in aging that would increase life expectancy by one year is worth $38 trillion and by 10 years is worth $367 trillion.
About MYMD-1
Originally developed for autoimmune diseases, MYMD-1’s primary purpose is to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. Because it can cross the blood-brain barrier and gain access to the central nervous system (CNS), MYMD-1 is also positioned to be a possible treatment for brain-related disorders. Its mechanism of action and efficacy in diseases including multiple sclerosis (MS) and thyroiditis have been studied through collaborations with several academic institutions. MYMD-1 is also showing promise in pre-clinical studies as a potential treatment for post- COVID-19 complications and as an anti-fibrotic and anti-proliferation therapeutic.
MYMD-1 has shown effectiveness in pre-clinical studies in regulating the immune system by performing as a selective inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of chronic inflammation. Unlike other therapies, MYMD-1 has been shown in these pre-clinical studies to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection. MYMD-1’s ease of oral dosing is another differentiator compared to currently available TNF-α blockers, all of which require delivery by injection or infusion. No approved TNF inhibitorTNF inhibitor has ever been dosed orally. In addition, the drug is not immunosuppressive and has not been shown to cause the serious side effects common with traditional therapies that treat inflammation.
About MyMD Pharmaceuticals, Inc.
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 delay aging, increase longevity, and treat autoimmune diseases and COVID-19- associated depression. 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.
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