Preclinical results showed MYMD-1® significantly reduced histopathological changes and the severity of standard arthritis clinical trial measures compared to placebo; demonstrate future potential to disrupt the TNF-α inhibitor market
MyMD Pharmaceuticals, Inc.® (NASDAQ:MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases, is presenting data from a preclinical study of investigational, oral TNF-α inhibitor MYMD-1® at the 2023 Society of Toxicology Annual Meeting (SOT) in Nashville, TN. Study results comparing MYMD-1 to placebo were very highly significant and showed MYMD-1 reduced histopathological changes and the severity of standard arthritis clinical trial measures.
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The study was designed to investigate the anti-inflammatory effects of MYMD-1® in a rheumatoid arthritis (RA) model that mimics features of arthritis in humans and included commonly used clinical arthritis endpoints. Histopathology parameters were very highly significant vs placebo for composite score (p<0.0001), bone resorption (p<0.0001), periosteal/exostatic change (p<0.001), inflammation (p<0.001), pannus/synovial hyperplasia (p<0.001), and in life pawn volume (p<0.001). Disease severity (total composite score) was reduced by 47% with MYMD-1® at 450 mg/kg/day orally versus a 37% reduction for etanercept 10 mg/kg by subcutaneous injection (see attached graphs).
“These results demonstrate the potential of MYMD-1® to inhibit arthritis development as shown in this research model,” said Sonia Edaye, Lead Investigator and Pharmacology/Discovery Scientist at Charles River Laboratories. “Unlike current TNF-α inhibitors, MYMD-1® can be given orally and is a promising investigational new drug for rheumatoid arthritis.”
“These very highly significant results are exciting and pave the way for our plans to develop MYMD-1 as a potential treatment for rheumatoid arthritis,” said Chris Chapman MD, President, Director, and Chief Medical Officer at MyMD Pharmaceuticals. “With its differentiated oral administration and selectivity, MYMD-1® has strong potential as a next-generation TNF-α inhibitor that may one day offer a new and meaningful therapeutic solution for the more than 1 million people affected by RA in the US1, many of whom are not served by current options.”
Poster #3046/P148 entitled “A Naturally Occurring Novel Therapeutic and Oral Selective Inhibitor of TNF-α, MYMD-1® (Isomyosamine) Significantly Reduced the Inflammation and Disease Severity in Murine Model of Collagen Antibody-Induced Arthritis,” is scheduled for poster presentation today March 20, 2023, at 9:00 AM CT.
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.
