Reneo Pharmaceuticals Announces Results from Pivotal STRIDE Study of Mavodelpar in Primary Mitochondrial Myopathies (PMM)

The STRIDE study did not meet its primary or secondary efficacy endpoint

The company to suspend mavodelpar development and implement a workforce reduction

IRVINE, Calif., Dec. 14, 2023 (GLOBE NEWSWIRE) -- Reneo Pharmaceuticals, Inc. (NASDAQ: RPHM), a pharmaceutical company focused on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, today announced its pivotal STRIDE study (NCT04535609) of mavodelpar in adult patients with primary mitochondrial myopathies (PMM) did not meet its primary efficacy or secondary efficacy endpoint. The primary efficacy endpoint of the trial was the change from baseline in the distance walked during the 12-minute walk test (12MWT) at week 24. The secondary efficacy endpoint was the change from baseline in the PROMIS Short Form Fatigue 13a score.

“We are immensely thankful to all the patients, families, and healthcare professionals who participated in the mavodelpar PMM development program,” said Gregory J. Flesher, President and CEO of Reneo Pharmaceuticals. “Although the results of the STRIDE study were negative, the data generated are vitally important to the scientific community and we will make these data available once the final analyses are complete. Finally, I want to thank all Reneo employees for their dedication and tireless contributions to advancing the science of mitochondrial disease.”

The company intends to implement immediate cost savings initiatives, including suspension of the ongoing STRIDE AHEAD study and all other mavodelpar development activities and a workforce reduction of approximately 70%. The company currently has over $100 million in cash, cash equivalents, and short-term investments.

About STRIDE

The STRIDE study was a global, randomized, double-blind, placebo-controlled pivotal Phase 2b trial of mavodelpar in adult patients with PMM due to mitochondrial DNA (mtDNA) defects. The study was designed to investigate the efficacy and safety of 100 mg mavodelpar administered once-daily over a 24-week period. The primary efficacy endpoint of the trial was the change from baseline in the distance walked during the 12-minute walk test (12MWT) at week 24. Secondary and exploratory endpoints included changes from baseline in PROMIS Short Form Fatigue 13a, Modified Fatigue Impact Scale (MFIS), Patient Global Impression of Change (PGIC), Patient Global Impression of Severity (PGIS), 30 Second Sit-To-Stand (30STS) Test, Brief Pain Inventory (BPI), 36-Item Health Survey (SF-36), Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP), and Pedometer Step Count.