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 first patient has been dosed in the STRIDE study. The trial is designed to evaluate the efficacy and safety of REN001 for the treatment of patients with primary mitochondrial myopathies (PMM).

STRIDE is a global, double-blind, randomized, placebo-controlled Phase 2b trial designed to assess the efficacy and safety of 100 mg REN001 administered orally, once-daily for 24 weeks. Approximately 200 adult patients with PMM caused by alterations in mitochondrial DNA are expected to be enrolled into STRIDE. The primary efficacy endpoint is the change from baseline in the distance walked during a 12-minute walk test after 24 weeks of treatment. Secondary efficacy endpoints include changes from baseline in the Modified Fatigue Impact Scale, Patient Global Impression of Change scale, and other patient-reported outcomes.

“We are truly excited about achieving this important milestone,” said Lynn Purkins, Ph.D., Senior Vice President of Clinical Operations. “Patients with PMM have genetic alterations that hamper the ability of their mitochondria to generate energy from nutrient sources, affecting multiple organ systems. It is a debilitating condition, for which there are unfortunately no approved treatment options. As we continue to advance REN001 in this patient population, we look forward to completing enrollment of the STRIDE study and sharing the results,” concluded Dr. Purkins.

REN001 is a potent and selective agonist of the peroxisome proliferator-activated receptor delta (PPARδ) receptor. The company has received Orphan Drug and Fast Track designations for REN001 from the U.S. Food and Drug Administration for PMM. In addition to PMM, the company is also developing REN001 for the treatment of other diseases that result from mitochondrial dysfunction or impaired energy production, including long-chain fatty acid oxidation disorders (LC-FAOD) and glycogen storage disorder type V (McArdle disease).

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). Reneo is developing REN001 to modulate genes critical to metabolism and generation of ATP, which is the primary source of energy for cellular processes. REN001 has been shown to increase transcription of genes involved in mitochondrial function and increase fatty acid oxidation and may increase production of new mitochondria.

About PMM

PMM are a group of disorders that affect roughly 1 in 5,000 people worldwide. PMM are caused by genetic mutations in the mitochondrial or nuclear DNA that reduce the ability of mitochondria to produce energy from nutrient sources. This energy deficit particularly affects tissues and organs with high energy demand such as muscle, brain, and heart. The symptoms of PMM include muscle weakness or 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 enrollment, conduct, progress, timing, and results of Reneo’s clinical trials, and the regulatory approval path for REN001. 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.

Contact:

Joyce Allaire
Managing Director
LifeSci Advisors, LLC
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Vinny Jindal
Chief Financial Officer
Reneo Pharmaceuticals, Inc.
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