MyMD Pharmaceuticals, Inc. announced the publication of results from a Phase 1 study of oral tumor necrosis factor-alpha (TNF-a) inhibitor, MYMD-1® (Isomyosamine), in peer-reviewed journal, Drug Research. The randomized, double-blind, placebo-controlled study, intended to evaluate the safety, tolerability, and pharmacokinetic profile of MYMD-1 in healthy adults, found that single daily doses for 3 days and multiple daily doses for 6 days were safe and well tolerated in healthy subjects. The study used single daily doses of 150 mg, 300 mg, and 450 mg, respectively, and multiple daily doses of 600 mg.

There were no new or unexpected safety findings and no clinically relevantor severe adverse events reported. MYMD-1 is currently being evaluated in Phase 2 studies for sarcopenia/frailty, a result of the aging process, with data expected in Fourth Quarter 2022. MYMD-1 has the potential to be the first drug approved by FDA for the condition.

The company also expects to initiate a clinical program in rheumatoid arthritis (RA), which affects more than 1.3 million Americans. Along with the growing aging population, autoimmune diseases like RA are becoming more prevalent. The National Institutes of Health estimates that autoimmune diseases overall may affect as many as 24 million Americans.

MYMD-1, an oral selective inhibitor of tumor necrosis factor-alpha (TNF-a), a driver of chronic inflammation, is being studied to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. MYMD-1 has shown effectiveness in pre-clinical and clinical studies in regulating the immune system. Unlike other therapies, MYMD-1 has been shown in these studies to selectively block TNF-a 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-a blockers, all of which require delivery by injection or infusion. No FDA-approved TNF 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.

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 and thyroiditis have been studied through collaborations with several academic institutions.