Reneo Pharmaceuticals Announces Last Patient Last Visit in the Pivotal STRIDE Study of Mavodelpar in Primary Mitochondrial Myopathies (PMM)
October 09 2023 - 7:50AM
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, announced last patient last visit (LPLV) in
the pivotal STRIDE study of mavodelpar in PMM. Topline data results
from the STRIDE study are expected in December 2023.
“This marks a major milestone for mavodelpar and
the company. This achievement reached in the STRIDE program
underscores the significant progress toward our corporate mission
to bring therapies to patients with rare genetic mitochondrial
diseases. We anticipate sharing topline results from the STRIDE
clinical trial in December 2023,” said Gregory J. Flesher, Chief
Executive Officer. “In addition, we are encouraged by the
participation in the ongoing STRIDE AHEAD study, which has enrolled
over 85% of eligible patients.”
Ashley Hall, Chief Development Officer, added “We
anticipate completing the final steps in the STRIDE clinical
process in the coming months. Subsequently, we plan to share the
results of data analysis with the United States Food and Drug
Administration (FDA) in the first quarter of 2024. We expect
that the STRIDE and STRIDE AHEAD studies will form the basis of a
New Drug Application (NDA) to the FDA which is planned for
submission in the first half of 2024 and thereafter to additional
regulatory agencies.”
About STRIDE The STRIDE study is
a global, randomized, double-blind, placebo-controlled pivotal
Phase 2b trial of mavodelpar in adult patients with PMM due to
mitochondrial DNA (mtDNA) defects. The study is designed to
investigate the efficacy and safety of 100 mg mavodelpar
administered once-daily over a 24-week period. The primary efficacy
endpoint of the trial is the change from baseline in the distance
walked during the 12-minute walk test (12MWT) at week 24. Secondary
endpoints include changes from baseline in PROMIS® Short Form
Fatigue 13a, Modified Fatigue Impact Scale (MFIS), Patient Global
Impression of Change (PGIC), Patient Global Impression of Severity
(PGIS), 30 Second Sit-To-Stand (30STS) Test, Brief Pain Inventory
(BPI), 36-Item Health Survey (SF-36), Work Productivity and
Activity Impairment Questionnaire: Specific Health Problem
(WPAI:SHP), and Pedometer Step Count.
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.
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.
Contacts:
Danielle Spangler Investor Relations
Reneo Pharmaceuticals, Inc. dspangler@reneopharma.com
Matthew Purcell, Pharm.D. Media Inquiries
Russo Partners, LLC matthew.purcell@russopartnersllc.com
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