MyMD Pharmaceuticals, Inc. announced that its Investigational New Drug (IND) application for a Phase 2 clinical trial of oral MYMD-1 as a treatment for rheumatoid arthritis (RA) was recently cleared by the U.S. Food and Drug Administration (FDA), and plans are underway for trial launch in the first quarter of 2024. Differentiated by its ease of oral dosing and selectivity, MYMD-1 is a TNF-a inhibitor with a small molecule design that 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 widely used RA therapy Enbrel® (etanercept).

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). Under this IND, the Phase 2 clinical trial of MYMD-1 will be a randomized placebo-controlled studythat is expected to enroll approximately 60 patients with active rheumatoid arthritis. Patients will receive oral MYMD-1 dosing of 1050 mg.

Rheumatoid arthritis 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. 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 has shown effectiveness in preclinical and clinical studies in regulating the immune system by performing as a selective inhibitor of tumor necrosis factor-alpha (TNF-a), a driver of chronic inflammation.

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 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.