Reneo Pharmaceuticals Achieves Target Enrollment in the Pivotal STRIDE Study of Mavodelpar (REN001) in Primary Mitochondrial Myopathies

Rhea-AI Summary

Reneo Pharmaceuticals, Inc. (RPHM) announces successful enrollment in the pivotal STRIDE study.

The company has achieved its target of enrolling 200 patients in the STRIDE study of mavodelpar (REN001) for primary mitochondrial myopathies (PMM). Topline data is expected in Q4 2023, with additional patients pending enrollment. Approximately 85% of eligible participants have also opted into the STRIDE AHEAD safety study.

The STRIDE trial is a global Phase 2b study aimed at assessing efficacy and safety over 24 weeks, with results submitted to the FDA and EMA planned for 2024.

Positive

• Successful enrollment of over 200 patients in the STRIDE study.
• 85% participation rate of eligible patients in the STRIDE AHEAD safety study.
• Topline data from the STRIDE study expected in Q4 2023.

Negative

• None.

Topline data from the STRIDE study expected in the fourth quarter of 2023

IRVINE, Calif., March 14, 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, today 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.

“We are very pleased to announce dosing of the 200^th patient in the ongoing STRIDE study,” said Gregory J. Flesher, President and CEO of Reneo Pharmaceuticals. “We achieved our target enrollment and have several pending patients that are awaiting their baseline visit. As such, we anticipate total enrollment of more than 200 patients and topline results in the fourth quarter of 2023. We are also pleased to see that approximately 85% of the eligible patients from STRIDE have opted to participate in STRIDE AHEAD, the mavodelpar two-year safety study.”

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). Our lead product candidate, mavodelpar, is a potent and selective agonist of the peroxisome proliferator-activated receptor delta (PPARδ). 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. For additional information, please see reneopharma.com.

About Mavodelpar

Mavodelpar (REN001) is a potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist currently in clinical development for two rare genetic mitochondrial diseases that typically present with myopathy and have high unmet medical needs: primary mitochondrial myopathies (PMM) and long-chain fatty acid oxidation disorders (LC-FAOD). For additional information, please see clinicaltrials.gov.

About PMM

PMM are a group of rare, genetic metabolic disorders caused by mutations or deletions in the mitochondrial DNA (mtDNA) or nuclear DNA (nDNA). These genetic alterations hamper the ability of mitochondria to generate energy from nutrient sources, resulting in energy deficits that are most pronounced in tissues with high energy demand such as muscle, brain, and heart. The symptoms of PMM include muscle weakness, exercise intolerance, movement disorder, deafness, blindness, and droopy eyelids among others. The prognosis for these disorders ranges in severity from progressive weakness to death.

Forward-Looking Statements 

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the completion of enrollment of clinical trials, announcement of topline data from the STRIDE study, and the submission of marketing applications. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plans,” “will,” “believes,” “anticipates,” “expects,” “intends,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Reneo’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Reneo’s business in general, and the other risks described in Reneo’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Reneo undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. 

Contacts: 

Danielle Spangler 
Investor Relations 
Reneo Pharmaceuticals, Inc. 
dspangler@reneopharma.com 

David Melamed, Ph.D. 
Media Inquiries 
Russo Partners, LLC 
david.melamed@russopartnersllc.com 

FAQ

What is the STRIDE study by Reneo Pharmaceuticals (RPHM)?

The STRIDE study is a pivotal Phase 2b clinical trial evaluating the efficacy and safety of mavodelpar (REN001) in adult patients with primary mitochondrial myopathies (PMM).

When is the topline data from the STRIDE study of Reneo Pharmaceuticals expected?

Topline data from the STRIDE study is expected in the fourth quarter of 2023.

How many patients were enrolled in the STRIDE study by Reneo Pharmaceuticals?

Reneo Pharmaceuticals achieved its target enrollment of over 200 patients in the STRIDE study.

What is the significance of the STRIDE AHEAD study related to Reneo Pharmaceuticals (RPHM)?

STRIDE AHEAD is a two-year safety study for mavodelpar, with 85% of eligible STRIDE participants opting to continue into this trial.

What regulatory submissions does Reneo Pharmaceuticals plan following the STRIDE study?

Reneo intends to submit data from the STRIDE study to the FDA and EMA for marketing applications in 2024.