MyMD Pharmaceuticals Inc
announced topline results from its randomized Phase 2 study of oral TNF-α inhibitor, MYMD-1, in patients with chronic inflammation associated with sarcopenia or age-related frailty.
The study met its primary endpoint 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.
The study met both of its primary endpoints, significantly reducing serum levels of three biomarkers, TNF-α (P=0.008), sTNFR1 (P=0.02), and IL-6 (P=0.03), 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 (AEs) or serious adverse events (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 28 days. The study consisted of four dosing cohorts versus placebo (600mg, 750mg, 900mg, and 1050mg).
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.
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