MyMD Pharmaceuticals Releases Positive Clinical Trial Results For Sarcopenia Treatment Drug

A condition that commonly affects elderly populations, sarcopenia results in the gradual loss of strength and physical function and has become an important healthcare issue worldwide in recent years. A sarcopenia diagnosis comes with a greater risk of hospitalization, disability and death. With no FDA-approved medications for sarcopenia currently on the market, there is a need for treatments that can help patients live with this disease. In Europe and the USA, the prevalence of sarcopenia with different diagnostic criteria ranges from 4.6% to 43% in communities and from 23% to 68% in clinical settings, and a high prevalence of sarcopenia can cause heavy healthcare expenditure and caregiver burden. 

But hope may be on the horizon – a pharmaceutical company’s new drug could change the way this debilitating disease and others are treated. 

As a clinical-stage biopharma company, MyMD Pharmaceuticals Inc. MYMD is committed to developing novel therapies for age-related diseases. With a focus on serious autoimmune and inflammatory diseases, the company’s lead clinical candidate, MYMD-1, is a tumor necrosis factor-alpha (TNF-alpha) inhibitor with the potential to extend a healthy lifespan for sarcopenia patients. 

Positive Trial Results 

MYMD-1 studies are testing the drug’s ability to slow the aging process and prevent sarcopenia. The drug’s oral dosing is a significant differentiator, making it easier to use than the currently available TNF-alpha inhibitors, all of which require delivery by injection or infusion.

MYMD-1 has shown effectiveness in pre-clinical and clinical studies in regulating the immune system through the modulation of numerous pro-inflammatory cytokines, including TNF-alpha, IL-6 and IL-17A. Unlike other therapies, MYMD-1 has shown its ability to selectively block TNF-alpha when it becomes overactivated in autoimmune diseases while allowing it to perform its normal job: being a first responder to any routine type of moderate infection. A lack of the serious side effects that are common with traditional immunosuppressive therapies that treat inflammation has also been promising during early studies of MYMD-1. 

In a recently completed phase 2 clinical trial, MYMD-1 met both of its primary endpoints, reducing the TNF-alpha, IL-6 and sTNFR1 biomarkers that are common in several chronic inflammatory diseases while meeting all secondary endpoints for safety and tolerability standards. The next-generation treatment met the secondary endpoints needed to advance the sarcopenia clinical program. The full study results will be released in 2024. 

“We are encouraged by the reduction of inflammatory markers along with the favorable safety profile demonstrated in this study of an oral TNF-alpha inhibitor,” said Chris Chapman, M.D., President, Director, and Chief Medical Officer at MyMD. “Sarcopenia can significantly affect people as they age, and there are currently no approved treatments for the condition. A selective, oral treatment that reduces TNF-alpha and inflammation and does not require infusion or injection would be a welcome advance for this population.”

If approved, MYMD-1 could become the first FDA-approved drug for sarcopenia, which causes patients to have a decline in muscle mass, among other symptoms. 

MyMD Pharmaceuticals has already submitted and been approved for three Investigational New Drug Applications for MYMD-1. The company is advancing these clinical programs in chronic inflammatory conditions, including sarcopenia, rheumatoid arthritis and Hashimoto’s disease, an often genetic disorder that causes inflammation of the thyroid gland. 

A small molecule that can cross the blood-brain barrier, MYMD-1 could potentially treat brain-related diseases and other autoimmune conditions such as rheumatoid arthritis. The drug’s positive momentum is signaling a changing landscape for the treatment of sarcopenia and other autoimmune diseases. With a unique form of administration, MYMD-1, taken orally, could potentially completely change how autoimmune diseases are treated in the future. 

Featured photo by National Cancer Institute on Unsplash.

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