FDA accepts MyMD Pharma’s IND for study of TNF-a inhibitor MYMD-1 in RA

MyMD Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted the Company’s Investigational New Drug Application IND to evaluate the safety, efficacy, pharmacodynamics and pharmacokinetics of oral TNF-a inhibitor MYMD-1 in patients with active rheumatoid arthritis RA. The application was based on preclinical data showing that MYMD-1 significantly reduced swelling and other clinical arthritis measures compared to widely used RA therapy, Enbrel or etanercept.1 The Company plans to initiate discussions with CRO vendor IQVIA on timing of a Phase 2 study in this indication. MYMD-1 is an oral, next-generation TNF-a inhibitor with the potential to transform the way TNF-a based diseases are treated due to its selectivity and ability to cross the blood brain barrier. Its ease of oral dosing is a significant differentiator compared to currently available TNF-a inhibitors, all of which require delivery by injection or infusion. MYMD-1 has also been shown to selectively block TNF-a action where it is overactivated without preventing it from doing its normal job of responding to routine infection. MYMD-1 is doubly effective at inhibiting inflammation by blocking both TNF-a and IL-6 activity, whereas currently approved anti-TNF and anti-IL-6 treatments for RA can only target one or the other. In addition, in early clinical studies it has not been associated with serious side effects known to occur with traditional immunosuppressive therapies that treat inflammation. “FDA acceptance of an IND in RA for our next-generation oral TNF-a inhibitor, MYMD-1, is our most significant milestone as it adds substantial momentum to our clinical program with sufficient funding and targets one of the largest potential market opportunities,” said Chris Chapman, M.D., president, director, and chief medical officer of MyMD. “We are excited to initiate discussions with our CRO regarding a Phase 2 clinical trial in RA and believe the statistically significant biomarker data from the Phase 2 study in sarcopenia show MYMD-1 has the potential to disrupt the TNF-a inhibitor market and offer therapeutic benefit to patients with a range of chronic inflammatory conditions.”