MyMD Pharmaceuticals, Inc. is presenting data on December 6, 2022 at the 2022 British Society for Immunology (BSI) Congress in Liverpool, England. Results from preclinical and clinical studies showed that MYMD-1 was safe and well-tolerated in healthy subjects and significantly reduced inflammation in a mouse model compared to the widely used arthritis treatment etanercept (Enbrel®). These findings support the continued evaluation of MYMD-1 for autoimmune and inflammatory disorders.

The studies were designed to investigate the safety and pharmacology profile of MYMD-1. In a preclinical study, repeat oral administration to mice in a collagen antibody induced arthritis (CAIA) model at 450 mg/kg/day significantly reduced the clinical score and paw swelling when compared to the CAIA disease control. In-life results showed % change of inflammation relative to control was reduced by 37% with MYMD-1 while reduction was 29% with etanercept at 10 mg/kg/day. In a clinical study of healthy adults, single daily oral doses each of 150 mg, 300 mg, and 450 mg for 3 days and multiple daily doses of 600 mg for 6 days were safe and well-tolerated.

Late-breaking abstract P-639 entitled “Pharmacology and clinical profile of MYMD-1® (isomyosamine), an oral, selective, next-generation, tumor necrosis factor-alpha (TNF- a) inhibitor that crosses the blood brain barrier,” is scheduled for poster presentation on December 6, 2022, at 6pm GMT. MYMD-1 is an oral next-generation TNF-a inhibitor with the potential to transform the way that TNF-a-based diseases are treated due to its selectivity and ability to cross the blood brain barrier. Its ease of oral dosing is a significant differentiator compared to currently available TNF-a inhibitors, all of which require delivery by injection or infusion.

MYMD-1 has also been shown to selectively block TNF-a where it is overactivated without preventing it from doing its normal job of responding to routine infection. It has not been associated with serious side effects common with traditional immunosuppressive therapies that treat inflammation. In addition to early-stage trials for rheumatoid arthritis, MyMD-1 is currently being evaluating in Phase 2 studies for sarcopenia/frailty, a result of the aging process, and has the potential to be the first drug approved by the FDA for the condition.