MyMD Pharmaceuticals Receives FDA Approval to Proceed with Investigational Rheumatoid Arthritis Drug

BALTIMORE – MyMD Pharmaceuticals, Inc. announced on Monday that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) Application to study the safety and effectiveness of the oral TNF-α inhibitor MYMD-1 in patients with active rheumatoid arthritis (RA).

A Breakthrough in Rheumatoid Arthritis Treatment?

MYMD-1, a next-generation inhibitor of TNF-α, shows promise as a new orally administered therapy for RA. The application is based on preclinical data demonstrating that MYMD-1 notably reduced swelling and other clinical measures of arthritis in comparison to Enbrel (etanercept), a widely used RA therapy. Unlike current TNF-α inhibitors, which require injections or infusions, MYMD-1 is orally administered.

The company is set to initiate discussions with CRO vendor IQVIA on the timing of a Phase 2 study. “This is significant news and suggests MYMD-1 may hold promise to be the first oral TNF-α inhibitor and a potential future treatment for rheumatoid arthritis,” said clinical researcher Robert W. Levin, MD.

The Potential to Transform TNF-α-Based Diseases Treatment

MYMD-1’s selectivity and ability to cross the blood-brain barrier make it a potential game-changer in treating TNF-α-based diseases. Its dual effectiveness at inhibiting inflammation and lack of serious side effects commonly associated with traditional immunosuppressive therapies could pave the way for new treatment possibilities.

“We are excited to initiate discussions with our CRO regarding a Phase 2 clinical trial in RA and believe MYMD-1 has the potential to disrupt the TNF-α inhibitor market and offer therapeutic benefit to patients with a range of chronic inflammatory conditions,” said Chris Chapman, M.D., president, director, and chief medical officer of MyMD.

Recent Success in Sarcopenia Treatment

Besides its potential application in RA, MyMD recently announced positive Phase 2 study results for MYMD-1 in treating sarcopenia, an age-related decline in muscle mass. Plans to initiate Phase 3 trials are underway, and if approved, MYMD-1 could be the first FDA-approved drug for sarcopenia.

Addressing a Widespread Medical Challenge

Rheumatoid arthritis, affecting nearly 14 million people globally, continues to pose a significant challenge to healthcare providers. With an estimated annual societal cost of $39.2 billion, the demand for effective treatments is pressing. Since 1998, TNF-α has played a central role in RA treatments, but all current treatments are administered via injection or infusion.

About MyMD Pharmaceuticals

MyMD is a clinical-stage biopharmaceutical company focused on developing innovative therapies for age-related diseases, autoimmune, and inflammatory conditions. The company’s robust portfolio also includes Supera-CBD, a synthetic cannabidiol (CBD) analog with potential applications in addiction, anxiety, chronic pain, seizures, and anti-inflammatory effects.

The acceptance of the IND by the FDA marks a critical milestone for MyMD, adding momentum to its clinical program and aligning with the company’s commitment to delivering meaningful solutions to patients with chronic inflammation and autoimmune diseases.