Tue. 12 Apr 2022, 9:32am ET Benzinga Biotech, General

MyMD seeks to disrupt the $31 billion global market for rheumatoid arthritis (RA) drug therapies with MYMD-1, which could potentially prove safer, more effective and better tolerated than current options

Submission of Investigational New Drug (IND) application and protocols for a Phase 2 RA study planned for second half of 2022

MyMD Pharmaceuticals, Inc. (NASDAQ:MYMD) ("MyMD" or "the Company"), a clinical stage pharmaceutical company committed to extending healthy lifespan, today announced positive new preclinical study data demonstrating the potential effectiveness of MYMD-1 for the treatment of rheumatoid arthritis (RA). MYMD-1 demonstrated a significantly greater anti-inflammatory effect than current TNF-alpha inhibitors on the market, the top three of which represent an estimated $31 billion market (based on 2020 revenues)1.

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Inhibition of Inflammation in Preclinical Model of Rheumatoid Arthritis (3) (Graphic: Business Wire)

The comparative study of arthritis, using the CAIA model2, was conducted and analyzed by Charles River Laboratories International, a full-service contract research organization for drug discovery and development. Study results showed that MYMD-1 inhibited inflammation more effectively in the RA model by 30% and 70% of the top two marketed drugs, respectively.

"We are excited about the impressive new data we are announcing today that shows a highly favorable comparison of our lead drug candidate MYMD-1 to the gold standard rheumatoid arthritis drug therapies currently on the market today. A small fraction of this enormous $31 billion market represents a highly attractive opportunity for MyMD," said Chris Chapman, M.D., President, Director and Chief Medical Officer of MyMD.

"Utilizing the strong proof-of-concept and efficacy data from our pre-clinical model, we are preparing to submit to the FDA an Investigational New Drug (IND) application for MYMD-1 as treatment for RA, along with protocols for a Phase 2 study, in the second half of this year."

In addition to the greater efficacy shown in the preclinical model of RA, we believe that MYMD-1 holds significant advantages over current anti-TNF-alpha therapies:

  • Smaller molecular size with easy access throughout the body, including the brain;
  • Selective inhibition of TNF-alpha production by lymphocytes involved in autoimmune disease, but not macrophages involved in front line immune protection against bacteria and viral infections;
  • Not shown to cause serious side effects in preclinical studies that is common with traditional therapies that treat inflammation;
  • Simultaneous inhibition of pro-inflammatory cytokines TNF-alpha, IL-6 and IL-17; and
  • Ease of oral dosing rather than by needle injection. Drug candidate MYMD-1 is the only TNF-alpha inhibitor that is dosed orally.

MyMD is currently conducting a Phase 2 clinical trial of MYMD-1 as a therapy for delaying aging and expanding healthy lifespan. The primary endpoint for the Phase 2 double-blind, placebo-controlled clinical trial is to achieve a reduction in circulating levels of TNF-alpha within 28 days of therapy.

In addition to aging and rheumatoid arthritis, MYMD-1's distinct action in regulating the immune system and treating chronic inflammation is being developed for the treatment of multiple sclerosis (MS), diabetes, and inflammatory bowel disease.