NEW YORK, NY, December 11, 2023 - The FDA has cleared an Investigational New Drug Application (IND) for MyMD Pharmaceuticals (Nasdaq: MYMD) to initiate a Phase 2 clinical trial of oral MYMD-1® as a treatment for rheumatoid arthritis (RA). The company plans to launch the trial in the first quarter of 2024.
“With the FDA’s recent clearance of our IND in RA, we are moving forward with plans to initiate a Phase 2 trial within the next several months. Results from preclinical studies have demonstrated MYMD-1’s potential to treat RA, and we believe this drug could one day be a disruptor in the massive market for similar treatments.”
Chris Chapman, M.D., president, director, and chief medical officer of MyMD Pharmaceuticals
Highlights
MYMD-1 is a TNF-α 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).
MyMD’s Phase 2 clinical trial of MYMD-1 will be a randomized placebo-controlled study that is expected to enroll approximately 60 patients with active rheumatoid arthritis.
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 is estimated to be over $40 billion annually.
About MyMD Pharmaceuticals, Inc.
MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to delay aging, increase longevity, and treat autoimmune diseases. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.mymd.com.
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