MyMD Pharmaceuticals® Provides Dosing Update on Phase 2 Multi-Center Clinical Trial of MYMD-1® as a Therapy for Delaying Aging and Extending Healthy Lifespan
MyMD Pharmaceuticals, a clinical-stage biopharmaceutical company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases, today announced a dosing update on its fully-funded Phase 2 clinical trial of lead drug candidate MYMD-1, an orally available next-generation TNF-alpha inhibitor, as a therapy for chronic inflammation associated with sarcopenia and frailty.
The Safety Review Committee has confirmed no safety or toxicity issues with the first 30 patients enrolled in this study and has voted unanimously to escalate to the final dose level. Thirty patients enrolled in Cohorts 1, 2, and 3 have completed dosing and end of study visits. To date, three subjects from Cohort 4 have completed end-of-study visits. There are no outstanding study visits and all 30 patients have officially completed all study parameters and been discharged from the study.
“We are proud of the notable progress that we have made thus far on our first Phase 2 study of MYMD-1,” said Chris Chapman MD, President, Director, and Chief Medical Officer at MyMD Pharmaceuticals. “As we move into the final cohort of this study, we remain hopeful in MYMD-1’s potential to transform future treatment of sarcopenia/frailty in the aging population.”
The Phase 2 multi-center double-blind, placebo controlled, randomized study is currently ongoing to investigate the efficacy, tolerability and pharmacokinetics of MYMD-1 in the treatment of chronic inflammation associated with sarcopenia/frailty inpatients aged 65 years or older. The study’s primary objective is to demonstrate reduction of chronic inflammatory markers in patients treated with MYMD-1® versus placebo. To qualify for the clinical trial, patients’ biomarkers during the screening period must be within the following criteria: IL-6 ≥ 2.5pg/mL; and/or sTNFR-1 ≥ 1500pg/mL. To date, MyMD has randomized and dosed 37 of 40 total patients across Cohorts 1 (n=10; 600mg), 2 (n=10; 750mg), 3 (n=10; 900mg) and 4 (n=7; 1050mg).
On average, it is estimated that 5 to 13% of elderly people between the ages of 60 and 70 are affected by sarcopenia. These numbers increase to 11 to 50% for those aged 80 or above. Currently, there are no FDA approved treatments for chronic inflammation associated with sarcopenia/frailty for those aged 65 years or older.
“The aging disorders market is expected to be at least $600 billion by 20252,” continued Dr. Chapman. “TNF-α blockers are the most prescribed drugs by revenue, a global market of approximately $40 billion per year.3 Studies have shown that a slowdown in aging that increases life expectancy by one year is worth $38 trillion and by 10 years is worth $367 trillion.”
MYMD-1® is an oral next-generation TNF-α inhibitor with the potential to transform the way that TNF-α based diseases are treated due to its selectivity and ability to cross the blood brain barrier. MyMD is planning early-stage trials for rheumatoid arthritis and will provide guidance as the program develops.
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