Reneo Pharmaceuticals Announces Last Patient Last Visit in the Pivotal STRIDE Study of Mavodelpar in Primary Mitochondrial Myopathies (PMM)

Topline data results from the STRIDE study are expected in December 2023

IRVINE, Calif., Oct. 09, 2023 (GLOBE NEWSWIRE) -- Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM), a clinical-stage pharmaceutical company focused on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, announced last patient last visit (LPLV) in the pivotal STRIDE study of mavodelpar in PMM. Topline data results from the STRIDE study are expected in December 2023.

“This marks a major milestone for mavodelpar and the company. This achievement reached in the STRIDE program underscores the significant progress toward our corporate mission to bring therapies to patients with rare genetic mitochondrial diseases. We anticipate sharing topline results from the STRIDE clinical trial in December 2023,” said Gregory J. Flesher, Chief Executive Officer. “In addition, we are encouraged by the participation in the ongoing STRIDE AHEAD study, which has enrolled over 85% of eligible patients.”

Ashley Hall, Chief Development Officer, added “We anticipate completing the final steps in the STRIDE clinical process in the coming months. Subsequently, we plan to share the results of data analysis with the United States Food and Drug Administration (FDA) in the first quarter of 2024.  We expect that the STRIDE and STRIDE AHEAD studies will form the basis of a New Drug Application (NDA) to the FDA which is planned for submission in the first half of 2024 and thereafter to additional regulatory agencies.”

About STRIDE
The STRIDE study is 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 is 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 is the change from baseline in the distance walked during the 12-minute walk test (12MWT) at week 24. Secondary endpoints include 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.