Epirium Bio, a clinical-stage biopharmaceutical company, announced positive Phase 1 clinical trial results for MF-300, a first-in-class oral 15-PGDH enzyme inhibitor in development for sarcopenia. According to the company, the trial met its primary safety endpoint, with MF-300 generally well tolerated across all doses and no participant discontinuations.
The randomized, double-blind, placebo-controlled trial included 70 healthy volunteers across single and multiple-ascending dose cohorts. The company said that MF-300 produced dose-dependent pharmacodynamic responses and increased urinary PGE2 levels, supporting target engagement and biological activity. Pharmacokinetic analyses indicated a half-life consistent with once-daily oral dosing.
Epirium Bio claims the observed effects align with preclinical findings showing improvements in muscle force and quality in aged mice. The company said dedicated cohorts of older adults are ongoing, with results expected by year-end.
The company plans to initiate a Phase 2 randomized, placebo-controlled trial in sarcopenia patients in mid-2026. Sarcopenia affects millions of older adults and currently has no FDA-approved treatments, the company said.
MF-300 is designed to inhibit 15-PGDH, an enzyme that degrades prostaglandin E2, which plays a key role in promoting muscle strength and neuromuscular function. Epirium Bio is developing this therapy as part of its broader portfolio targeting neuromuscular and fibrotic diseases.
