MyMD Pharmaceuticals announces MYMD-1 met primary, secondary endpoints

MyMD Pharmaceuticals announced statistically significant topline results from its randomized Phase 2 study of oral TNF-a inhibitor, MYMD-1 in patients with chronic inflammation associated with sarcopenia, or age-related frailty. The study met its primary endpoints of significantly reducing chronic inflammatory markers in participants treated with MYMD-1. MYMD-1 has the potential to be the first drug approved by the FDA for sarcopenia, an age-related decline in physical function which leads to greater risk of hospitalization, disability, and death. The study met both of its primary endpoints, significantly reducing serum levels of three biomarkers, TNF-a, sTNFR1 and IL-6 and maintaining appropriate plasma concentrations and parameters in pharmacokinetic evaluations. The study also achieved all secondary endpoints related to safety and tolerability. There were no treatment-related adverse events, or AEs, or serious adverse events, or SAEs, over the course of the study. The Phase 2 multi-center double-blind, placebo controlled, randomized study was designed to investigate the efficacy, tolerability and pharmacokinetics of MYMD-1 in participants aged 65 years or older with chronic inflammation associated with sarcopenia/frailty, a condition linked to elevated levels of proinflammatory cytokines. Patients in the study were dosed weekly with MYMD-1 or placebo over a 28-day period. The study consisted of four dosing cohorts versus placebo. Full results from the study will be presented or published at a later date to be determined. The company plans to initiate discussions with the FDA regarding a Phase 3 study of MYMD-1 in sarcopenia.