Company expects to share topline results later this Quarter
SAN DIEGO--(BUSINESS WIRE)--Epirium Bio Inc. (Epirium), a clinical-stage biopharmaceutical company advancing medicines for neuromuscular and fibrotic diseases, today announced the completion of dosing in its Phase 1 trial. The randomized, double-blind, placebo-controlled single and multiple-ascending dose (SAD and MAD) trial was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MF-300 in healthy adults. MF-300 is an investigational, first-in-class, orally administered, 15-hydroxyprostaglandin dehydrogenase (15-PGDH) enzyme inhibitor currently in development for the treatment of sarcopenia, or age-related muscle weakness. Preliminary data indicate all adverse events were considered mild to moderate, with no severe or serious adverse events reported. Further, there were no early discontinuations, and no stopping criteria were met.
“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.”
About MF-300
MF-300 is an investigational, orally bioavailable small molecule that reversibly occupies the prostaglandin E2 (PGE2) binding site of 15-hydroxyprostaglandin dehydrogenase (15-PGDH). 15-PGDH is an enzyme that metabolically degrades PGE2 and is transcriptionally upregulated in aged muscle. Preclinical data show that PGE2 plays a crucial role in promoting aged muscle strength by improving muscle quality (i.e., muscle strength independent of muscle mass) as well as function of the neuromuscular junction. In preclinical studies, oral administration of MF-300 increases physiologic levels of PGE2 in skeletal muscle in rats and it increases muscle force and improves muscle quality in aged mice. Inhibiting 15-PGDH in aged muscle may be a strategy to increase physiologic levels of PGE2 to improve muscle quality and function in sarcopenia.
About Sarcopenia
The U.S. Food and Drug Administration (FDA) estimates that up to a third of Americans over the age of 60 are affected by sarcopenia, a disease that increases the risk of falls, fractures, disability and all-cause mortality. Despite sarcopenia’s widespread prevalence and serious health implications, there are currently no FDA-approved therapies available to treat sarcopenia, highlighting the significant unmet medical need for this disease.
About Epirium Bio
Epirium, a biopharmaceutical company based in San Diego, California, has identified and established an IP-protected platform of orally bioavailable small molecules that constitute a new class of therapeutics with the potential to improve function in neuromuscular diseases, including sarcopenia and spinal muscular atrophy. Epirium has generated preclinical data in a broader scope of indications with significant unmet medical need, including fibrosis, which Epirium’s development pipeline has the potential to address.
To learn more about Epirium, please visit www.epirium.com and follow us on LinkedIn.
Contacts
Email: info@epirium.com
