MyMD reports positive results in Phase 2 sarcopenia trial

Study of TNF-α inhibitor in patients with sarcopenia shows statistically significant reductions in chronic inflammatory markers.

Clinical stage longevity pharma company MyMD Pharmaceuticals has announced positive topline results from its Phase 2 study of MYMD-1, an oral TNF-α inhibitor, in patients with chronic inflammation associated with sarcopenia, or age-related frailty. The study showed statistically significant reductions in chronic inflammatory markers, with MYMD-1 demonstrating effectiveness across three biomarkers: TNF-α, sTNFR1, and IL-6.

Sarcopenia, a condition characterized by a decline in physical function associated with aging, can lead to increased risks of hospitalization, disability, and mortality. The are currently no FDA-approved drugs for treatment of the condition.

The Phase 2 study, a multi-center double-blind, placebo-controlled, randomized trial, enrolled participants aged 65 years or older with chronic inflammation associated with sarcopenia. MYMD-1 was dosed weekly in four different cohorts (600mg, 750mg, 900mg, and 1050mg) versus a placebo over a 28-day period. The primary endpoints of the study were met, showing significant reduction in serum levels of the targeted biomarkers. Moreover, MYMD-1 maintained appropriate plasma concentrations and parameters in pharmacokinetic evaluations. The study also achieved all secondary endpoints related to safety and tolerability, with no treatment-related adverse events reported.

The company says that the positive results from the Phase 2 study open the door for discussions with the FDA regarding a Phase 3 study of MYMD-1 in sarcopenia. The drug has also shown promise in regulating the immune system and may have applications beyond sarcopenia in treating autoimmune and inflammatory diseases.

“We are very excited about these results indicating MYMD-1 demonstrated statistically significant reductions in all three inflammatory markers and met all additional pharmacokinetic and safety endpoints needed to advance our sarcopenia clinical program, with guidance from the FDA,” said Dr Chris Chapman, Chief Medical Officer at MyMD. “These results support the unique advantages of MYMD-1 as the first oral, selective TNF-α inhibitor candidate and potential future treatment option for sarcopenia and other autoimmune conditions such as rheumatoid arthritis.”

MYMD-1 is a next-generation, oral selective inhibitor of tumor necrosis factor-alpha (TNF-α), which plays a key role in chronic inflammation. MYMD-1 selectively blocks TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms while allowing it to function as a first responder to routine infections. The company says this specificity may reduce the risk of serious side effects common with traditional immunosuppressive therapies for inflammation.

“We are encouraged by the reduction of inflammatory markers along with the favorable safety profile demonstrated in this study of an oral TNF-α inhibitor,” said Chapman. “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-α and inflammation and does not require infusion or injection would be a welcome advance for this population.”

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