Reneo Pharmaceuticals Says Metabolic Disorder Program To Enter Next Stage Of Development

Reneo Pharmaceuticals Inc RPHM has reported results from the REN001 long-chain fatty acid oxidation disorders (LC-FAOD) study and provided additional development updates.
In the LC-FAOD Phase 1b study, REN001 was safe and well tolerated. The most common adverse events experienced by patients were rhabdomyolysis and myalgia, the majority reported to be mild or moderate in severity.
REN001 improved fatigue in the LCHAD and CPT2 sub-set of patients, but in VLCAD patients, there was a decrease in the fatigue score.
Based on the results, the company intends to continue the development of REN001 for patients with LC-FAOD.
It plans to request meetings with U.S. and European regulatory agencies to discuss the results of the studies and obtain alignment on the study design, patient population, and endpoints.
Reneo is currently enrolling in the STRIDE Phase 2b trial to assess the efficacy and safety of 100 mg REN001 administered orally once daily to approximately 200 adult primary mitochondrial myopathies (PMM) patients with mtDNA defects and a history of myopathy.
Enrollment will conclude by year-end 2022, with topline data anticipated in 2H of 2023.
A new program for PMM patients with nuclear DNA (nDNA) defects will be initiated.
Price Action: RPHM shares are up 1.56% at $3.25 during the market session on the last check Tuesday.