Reneo Pharmaceuticals, Inc. announced that the company has achieved the target enrollment in the pivotal STRIDE study of mavodelpar (REN001) in primary mitochondrial myopathies (PMM). Topline data from the STRIDE study are expected in the fourth quarter of 2023. STRIDE is a global, randomized, double-blind, placebo-controlled pivotal Phase 2b trial of mavodelpar in adult patients with PMM due to mitochondrial (mtDNA) defects.

The STRIDE study is designed to assess the efficacy and safety of 100 mg mavodelpar administered orally, once daily for 24 weeks. The primary efficacy endpoint is the change from baseline in the distance walked during the 12-minute walk test at week 24. STRIDE AHEAD is a 24-month, open-label, long-term safety trial outside of the United States in patients with PMM.

The STRIDE AHEAD study was recently amended to allow enrollment of patients with PMM due to both mtDNA and nuclear DNA (nDNA) defects. Reneo intends to submit the data from STRIDE, together with the long-term safety data from STRIDE AHEAD, to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in planned marketing applications in 2024. About Reneo Pharmaceuticals Reneo is a clinical-stage pharmaceutical company focused on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, which are often associated with the inability of mitochondria to produce adenosine triphosphate (ATP).

lead product candidate, mavodelpar, is a potent and selective agonist of the peroxisome proliferator-activated receptor delta (PPAR). Mavodelpar has been shown to increase transcription of genes involved in mitochondrial function and increase fatty acid oxidation (FAO), and may increase production of new mitochondria.