Reneo Pharmaceuticals Achieves Target Enrollment in the Pivotal STRIDE Study of Mavodelpar (REN001) in Primary Mitochondrial Myopathies
March 14 2023 - 7:30AM
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 200th 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
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