Reneo Pharmaceuticals Announces Last Patient Last Visit in STRIDE Study of Mavodelpar for Rare Genetic Mitochondrial Diseases

Reneo Pharmaceuticals, a clinical-stage pharmaceutical company focused on developing therapies for patients with rare genetic mitochondrial diseases, has reached a significant milestone in its STRIDE study of mavodelpar. The company announced the completion of the last patient last visit (LPLV) in the pivotal Phase 2b trial.

The STRIDE study is a global, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of mavodelpar in adult patients with primary mitochondrial myopathy (PMM) caused by mitochondrial DNA (mtDNA) defects. The primary endpoint of the trial is the change in distance walked during the 12-minute walk test at week 24. Secondary endpoints include fatigue levels, patient global impression of change, pain inventory, and more.

With the LPLV achieved, Reneo Pharmaceuticals expects to release topline data results from the STRIDE study in December 2023. This marks a major milestone for mavodelpar and the company, bringing them closer to their mission of providing therapies for patients with rare genetic mitochondrial diseases.

Gregory J. Flesher, Chief Executive Officer of Reneo Pharmaceuticals, expressed his excitement about the achievement and the progress made towards their corporate mission. He also mentioned the ongoing STRIDE AHEAD study, which has enrolled over 85% of eligible patients, further demonstrating the company’s commitment to addressing the unmet medical needs of patients with these rare diseases.

Ashley Hall, Chief Development Officer, added that the final steps in the STRIDE clinical process are expected to be completed in the coming months. Following that, the company plans to share the results of data analysis with the United States Food and Drug Administration (FDA) in the first quarter of 2024. The data from the STRIDE and STRIDE AHEAD studies will form the basis of a New Drug Application (NDA) to the FDA, with submission planned for the first half of 2024 and subsequent submissions to additional regulatory agencies.

Mitochondrial diseases, such as PMM, are rare genetic metabolic disorders caused by mutations or deletions in mitochondrial DNA or nuclear DNA. These disorders lead to energy deficits, affecting tissues with high energy demand, such as muscles, brain, and heart. Symptoms include muscle weakness, exercise intolerance, movement disorders, and sensory impairments.

Mavodelpar (REN001), the lead product candidate of Reneo Pharmaceuticals, is a potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist. It is currently being developed for PMM and long-chain fatty acid oxidation disorder, addressing the high unmet medical needs of patients with these conditions.

Reneo Pharmaceuticals is dedicated to the development and commercialization of therapies for patients with rare genetic mitochondrial diseases. Their lead product candidate, mavodelpar, shows promising potential in improving mitochondrial function and energy production.

As the STRIDE study progresses and the company moves closer to potential regulatory submissions, Reneo Pharmaceuticals remains committed to bringing hope and innovative treatments to patients suffering from these rare genetic mitochondrial diseases.