Reneo Pharmaceuticals Announces Last Patient Last Visit in the Pivotal STRIDE Study of Mavodelpar in Primary Mitochondrial Myopathies (PMM) - Seite 2
About STRIDE AHEAD
The STRIDE AHEAD study is an open-label extension (OLE) trial outside of the United States in patients with PMM due to mtDNA defects who participated in STRIDE or the mavodelpar Phase 1b study. The
study is designed to evaluate the long-term safety and tolerability of 100 mg mavodelpar administered once-daily over a 24-month period. STRIDE AHEAD was amended to allow enrollment of treatment
naïve patients with PMM due to nuclear DNA (nDNA) defects.
About PMM
PMM are a group of rare, genetic metabolic disorders caused by mutations or deletions in the mtDNA or 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.
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: PMM and long-chain fatty acid oxidation disorder. For additional information, please see clinicaltrials.gov.
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 (REN001), 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, increase fatty acid oxidation, and may increase production of new
mitochondria. For additional information, please see reneopharma.com.
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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 potential development, registration and commercialization of mavodelpar, the timing of topline
data from the STRIDE study, the timing of the final steps in the clinical process for the STRIDE study and for sharing the results of data analysis with the FDA, the prospects of the STRIDE AHEAD
study, and the potential filing and timing of an NDA to the FDA and thereafter to additional regulatory agencies. 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.