Reata Provides Update on Omaveloxolone Program for Patients with Friedreich’s Ataxia
November 24 2020 - 5:00PM
Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,”
or “we”), a clinical-stage biopharmaceutical company, today
announced that the U.S. Food and Drug Administration (“FDA”)
completed its internal review of the Baseline-Controlled Study
results of omaveloxolone for the treatment of patients with
Friedreich’s ataxia (“FA”) and concluded that the results do not
strengthen the results of Part 2 of the MOXIe study. The FDA
proposed some additional exploratory analyses using patients
randomized to placebo during the MOXIe Part 2 study, but stated
that the potential for these analyses to strengthen the study
results was questionable due to the small number of patients
available for analysis. The FDA stated that they remain interested
in reviewing the results of the additional exploratory analyses as
those may inform the future development program.
The Company plans to submit to the FDA the analyses
that they proposed and to request a meeting with the FDA to discuss
the development program. In addition, based on the FDA’s
conclusion, the Company is considering the next steps for the
development program, including whether to conduct a second pivotal
study in patients with FA.
“Omaveloxolone improved motor function as measured
by the modified Friedreich’s Ataxia Rating Scale in both Part 2 of
the MOXIe study and the Baseline-Controlled study. We are grateful
to the families, physicians, investigators, and advocates who have
supported this program to date,” said Warren Huff, Reata’s Chairman
and Chief Executive Officer. “Though we are disappointed in the
FDA’s feedback on this program, we will carefully consider the
potential paths forward for making omaveloxolone available to
patients with FA.”
About Friedreich's Ataxia
FA is a rare, inherited, life-shortening,
debilitating, and degenerative neuromuscular disorder, which is
normally diagnosed during adolescence. FA is typically caused by a
trinucleotide repeat expansion in the first intron of the frataxin
gene, which encodes the mitochondrial protein frataxin. Pathogenic
repeat expansions can lead to impaired transcription and reduced
frataxin expression, which can lead to mitochondrial iron overload
and poor cellular iron regulation, increased sensitivity to
oxidative stress, and impaired mitochondrial ATP production.
Patients with FA experience initial symptoms in childhood,
including progressive loss of coordination, muscle weakness, and
fatigue, commonly resulting in motor incapacitation, with patients
requiring a wheelchair by their teens or early 20s. FA patients may
also experience visual impairment, hearing loss, diabetes, and
cardiomyopathy. Based on literature and proprietary research, we
believe FA affects approximately 5,000 children and adults in the
United States and 22,000 individuals globally. There are currently
no approved therapies for the treatment of FA.
About Omaveloxolone
Omaveloxolone is an investigational, oral,
once-daily activator of Nrf2, a transcription factor that induces
molecular pathways that promote the resolution of inflammation by
restoring mitochondrial function, reducing oxidative stress, and
inhibiting pro-inflammatory signaling. The FDA has granted Orphan
Drug designation to omaveloxolone for the treatment of Friedreich’s
ataxia. The European Commission has granted Orphan Drug designation
in Europe to omaveloxolone for the treatment of Friedreich’s
ataxia.
About Reata Pharmaceuticals,
Inc.
Reata is a clinical-stage biopharmaceutical company
that develops novel therapeutics for patients with serious or
life-threatening diseases by targeting molecular pathways involved
in the regulation of cellular metabolism and inflammation. Reata’s
two most advanced clinical candidates, bardoxolone methyl
(“bardoxolone”) and omaveloxolone, target the important
transcription factor Nrf2 that promotes the resolution of
inflammation by restoring mitochondrial function, reducing
oxidative stress, and inhibiting pro-inflammatory
signaling. Bardoxolone and omaveloxolone are
investigational drugs, and their safety and efficacy have not been
established by any agency.
Contact:Reata Pharmaceuticals,
Inc.(972) 865-2219http://reatapharma.com
Investor Relations Vinny Jindal
(469) 374-8721
ir@reatapharma.comhttp://reatapharma.com/contact-us/
Forward-Looking Statements
This press release includes certain disclosures
that contain “forward-looking statements,” including, without
limitation, statements regarding the success, cost and timing of
our product development activities and clinical trials, our plans
to research, develop and commercialize our product candidates, our
plans to submit regulatory filings, and our ability to obtain and
retain regulatory approval of our product candidates. You can
identify forward-looking statements because they contain words such
as “believes,” “will,” “may,” “aims,” “plans,” “model,” and
“expects.” Forward-looking statements are based on
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forward-looking statements relate to the future, they are subject
to inherent uncertainties, risks, and changes in circumstances that
may differ materially from those contemplated by the
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Important factors that could cause actual results to differ
materially from those in the forward-looking statements include,
but are not limited to, (i) the timing, costs, conduct, and outcome
of our clinical trials and future preclinical studies and clinical
trials, including the timing of the initiation and availability of
data from such trials; (ii) the timing and likelihood of regulatory
filings and approvals for our product candidates; (iii) whether
regulatory authorities determine that additional trials or data are
necessary in order to obtain approval; (iv) the potential market
size and the size of the patient populations for our product
candidates, if approved for commercial use, and the market
opportunities for our product candidates; and (v) other factors set
forth in Reata’s filings with the U.S. Securities and Exchange
Commission, including the detailed factors discussed under the
caption “Risk Factors” in its Annual Report on Form 10-K for the
fiscal year ended December 31, 2019. The forward-looking statements
speak only as of the date made and, other than as required by law,
we undertake no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events, or otherwise.
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