MyMD Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted their investigational new drug application to analyze the safety and efficacy of the novel TNF-α inhibitor MYMD-1 in patients with rheumatoid arthritis. The FDA’s acceptance comes after the novel agent demonstrated the potential to decrease disease severity when compared with the current standard therapy for this patient population, etanercept, in a preclinical study. Researchers explained that because the TNF-α inhibitor is an oral drug capable of crossing the blood-brain barrier, the agent may be easier to administer as well as more effective in managing inflammation and selectively blocking TNF-α overactivation without interfering with its ability to respond to infections. Further, a previous phase II study indicated that MYMD-1 may offer clinical benefit in patients with sarcopenia and frailty, potentially paving the way for the agent’s approval. Patients who have received the novel inhibitor have experienced no serious side effects. “MYMD-1 may hold promise to be the first oral TNF-α inhibitor and a potential future treatment for rheumatoid arthritis. There remains a need for new oral therapies with novel mechanisms of action for patients not served by current options,” concluded Robert W. Levin, MD, a rheumatologist at Mease Countryside Hospital.
August 31, 2023