MyMD and Charles River Present Positive Preclinical Results for Oral TNF-α Inhibitor MYMD-1® in Rheumatoid Arthritis

MyMD Pharmaceuticals, Inc.®, a clinical stage biopharma 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.

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).

Sonia Edaye, Lead Investigator and Pharmacology/Discovery Scientist at Charles River Laboratories said:

“These results demonstrate the potential of MYMD-1® to inhibit arthritis development as shown in this research model. Unlike current TNF-α inhibitors, MYMD-1® can be given orally and is a promising investigational new drug for rheumatoid arthritis.”

Chris Chapman MD, President, Director, and Chief Medical Officer at MyMD Pharmaceuticals stated:

“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. 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.”

See 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.” Source: BUSINESS WIRE (Graphic: Business Wire)

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.

Study Design

The research model was induced by an intravenous injection of a monoclonal antibodies cocktail that directed to collagen type II on Day 1 (sensitization), followed by an intraperitoneal injection of the endotoxin LPS on Day 6 (boost immunization). Three doses of MYMD-1® (50, 250 and 450 mg/kg/day) were tested, and the dose formulations were administered by oral gavage, twice daily, starting at the onset of the disease (Day 8 in this study). Etanercept (a biologic TNF-α inhibitor) and Dexamethasone (a glucocorticoid) were also administered respectively twice weekly by subcutaneous injection (10 mg/kg) and daily by oral gavage (3 mg/kg) as positive controls.

About MyMD Pharmaceuticals

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), is a clinical stage biopharma company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases. MyMD’s lead clinical candidate, MYMD-1®, is an orally available next-generation TNF-α inhibitor with the potential to transform the way that TNF-α based diseases are treated. MYMD-1®, with its small molecule design, improved safety profile and ability to cross the blood brain barrier, has the promise to provide meaningful therapeutic solutions to patients not served by current TNF-α inhibitors and as a potential therapy for CNS-based inflammatory and autoimmune diseases. MYMD-1® has demonstrated the potential to slow the aging process and extend healthy lifespan. The company is evaluating MYMD-1® in Phase 2 studies for sarcopenia/frailty, a result of the aging process, as well as early-stage trials for rheumatoid arthritis (RA), with the potential to expand into other applications.

MyMD’s second therapeutic candidate is Supera-CBD, a novel, synthetic, non-toxic cannabidiol (CBD) analog that is 8000 times more potent a CB2 agonist (activator) than plant-based CBD. The U.S. Drug Enforcement Administration (DEA) has determined that Supera-CBD will not be classified as a regulated chemical or require scheduling during development. In addition to its potential role in managing addiction, anxiety, chronic pain and seizures, Supera-CBD has also been shown to have anti-inflammatory effects.

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Source: MyMD Pharmaceuticals, Inc., Press Release 20 March 2023

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