MyMD Pharmaceuticals Readies MyMD-1 for the Clinic Following Strong Preclinical Data

By Alex Keown
March 20, 2023

MyMD Pharmaceuticals continued to build the case to initiate in-human studies with its experimental, next-generation rheumatoid arthritis treatment, MyMD-1.

At the 2023 Society of Toxicology Annual Meeting in Nashville, Baltimore-based MyMD presented preclinical data that showed MyMD-1, an oral next-generation TNF-α inhibitor, significantly reduced signs of arthritis. Data showed MYMD-1 reduced histopathological changes and the severity of standard arthritis clinical trial measures, the company announced.

Chris Chapman, President and Chief Medical Officer of MyMD Pharmaceuticals, called the results exciting. Chapman said the data paves the way for the development of MYMD-1 as a potential treatment for rheumatoid arthritis. The preclinical data was shared in the poster presentation “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.”

“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 U.S., many of whom are not served by current options,” Chapman said in a statement.

MYMD-1 is an oral TNF-α inhibitor the company believes has the potential to transform the way that TNF-α based diseases are treated due to the experimental drug’s selectivity and ability to cross the blood brain barrier. A synthetic derivative of tobacco alkaloids, MYMD-1 regulates the immuno-metabolic system through the modulation of numerous pro-inflammatory cytokines, including TNF-α, IL-6 and IL-17A. The drug candidate targets the root cause of inflammation, which is a core issue with these different disease types. In a previous interview with BioBuzz, MyMD Chief Scientific Officer Adam Kaplin said MYMD-1 cuts off inflammation at the source and allows the body’s immune response to function properly.

The preclinical study evaluated the anti-inflammatory effects of MYMD-1 in a rheumatoid arthritis (RA) model that mimics features of arthritis in humans. MyMD Pharmaceuticals and its partner, Charles River Labs, noted the study included commonly used clinical arthritis endpoints. Data from the preclinical program showed disease severity was reduced by 47% compared to a 37% reduction for Amgen’s Enbrel (etanercept), an anti-TNF receptor that is administered through subcutaneous injection. Additionally, the preclinical data showed histopathology parameters were very highly significant compared to placebo for composite score, bone resorption, periosteal/exostatic change, inflammation, pannus/synovial hyperplasia, and in life pawn volume, the companies said.

“These results demonstrate the potential of MYMD-1® to inhibit arthritis development as shown in this research model,” Sonia Edaye, lead investigator and pharmacology/discovery scientist at Charles River Laboratories said in a statement.

The preclinical data comparing MYMD-1 to Enbrel follows a study conducted by Eurofins that compared MYMD-1 against other TNFi biological drugs, including Enbrel, Janssen’s Remicade and AbbVie’s Humira. The Eurofins study found MYMD-1 generated significant anti-proliferative effects by inhibiting cell growth and allowing the innate immune response to battle an infection.

With the strong preclinical data, MyMD is planning early-stage trials for rheumatoid arthritis. The company said it will provide guidance as the program develops.

Beyond rheumatoid arthritis, MyMD believes MyMD-1 has applications in multiple disease indications. The company anticipates assessing the experimental drug as a potential treatment for multiple sclerosis, as well as chronic inflammation in frailty and sarcopenia.

Beyond MYMD-1, the company is also developing Supera-CBD, a novel synthetic derivative of cannabidiol. Supera-CBD targets numerous key receptors including CB2 and opioid receptors and inhibits monoamine oxidase.