SAN DIEGO — Epirium Bio has completed dosing in its first-in-human Phase 1 clinical trial evaluating MF-300, an oral, first-in-class 15-hydroxyprostaglandin dehydrogenase (15-PGDH) enzyme inhibitor being developed for the treatment of sarcopenia, the company announced Monday.
The randomized, double-blind, placebo-controlled study was designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of MF-300 in healthy adults through single and multiple ascending dose cohorts. According to preliminary findings, all reported adverse events were mild to moderate, with no serious or severe reactions, no early withdrawals, and no stopping criteria met during the trial.
“We are pleased to have completed dosing, and anticipate sharing the results later this quarter,” said Alex Casdin, Chief Executive Officer of Epirium. “We look forward to gaining valuable insights from this first-in-human investigational study of MF-300 ahead of our Phase 2 safety and efficacy trial in patients with sarcopenia, which is projected to commence enrollment mid-2026.”
Sarcopenia, characterized by progressive loss of muscle mass and strength due to aging, is a growing public health concern. Epirium’s MF-300 represents a novel therapeutic approach targeting 15-PGDH, an enzyme involved in tissue regeneration and repair.
Topline results from the Phase 1 trial are expected to be released later this quarter.
