Reata Receives Orphan Drug Designation from the European Commission for Omaveloxolone for the Treatment of Friedreich’s Ata...
July 10 2018 - 4:18PM
Reata Pharmaceuticals, Inc. (Nasdaq:RETA), a clinical-stage
biopharmaceutical company, today announced that the European
Commission has granted orphan drug designation for omaveloxolone
for the treatment of Friedreich’s ataxia (FA), based on the
positive opinion from the Committee for Orphan Medicinal Products
of the European Medicines Agency (EMA).
FA is an inherited, debilitating, and
degenerative neuromuscular disorder that is typically diagnosed
during adolescence and can ultimately lead to early death.
Patients with FA experience progressive loss of coordination,
muscle weakness, and fatigue that commonly progresses to motor
incapacitation and wheelchair reliance. FA affects
approximately 6,000 children and adults in the United States and
22,000 globally. Currently, there are no drugs approved for
the treatment of FA.
Last year, Reata reported results from part 1 of
MOXIe, a two-part, international, multi-center, randomized,
double-blind, placebo-controlled Phase 2 trial studying the safety
and efficacy of omaveloxolone in patients with FA. Treatment
of FA patients with omaveloxolone produced dose- and time-dependent
improvements in their modified Friedreich’s Ataxia Rating Scale
(mFARS) scores, which are a measure of the neurologic function of
FA patients. Reata is currently enrolling approximately 100
FA patients in the registrational part 2 portion of MOXIe and
expects to have results in the second half of 2019.
“Orphan drug designation from the EMA is an
important recognition of the potential for omaveloxolone to become
the first approved therapy for patients affected by this
devastating disease,” said Warren Huff, Reata’s President and Chief
Executive Officer.
In Europe, orphan drug designation is granted to
therapies intended for the treatment of life-threatening or
chronically debilitating diseases that affect no more than five in
10,000 people in the European Union and for which no satisfactory
treatments are available, or where the new therapy has the
potential to be a significant benefit to those affected by the
disease. Orphan designation provides specific financial and
regulatory incentives, including reduced fees, protocol assistance,
access to the centralized authorization procedure, and ten years of
market exclusivity once the drug is approved.
About Omaveloxolone
Omaveloxolone is an experimental, 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 United States Food
and Drug Administration has granted orphan designation to
omaveloxolone for the treatment of FA.
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 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.
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, 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,” and “expects.” Forward-looking statements
are based on Reata’s current expectations and assumptions.
Because 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 forward-looking statements, which are neither statements of
historical fact nor guarantees or assurances of future
performance. 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) 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 (iv) other factors set forth in Reata’s filings
with the U.S. Securities and Exchange Commission, including its
Annual Report on Form 10-K, under the caption “Risk Factors.”
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.
Contact:Reata Pharmaceuticals, Inc.(972)
865-2219info@reatapharma.comhttp://news.reatapharma.com
Investor Relations:Vinny JindalVice President,
Strategy(469) 374-8721ir@reatapharma.com
Media:Matt Middleman, M.D.LifeSci Public
Relations(646)
627-8384matt.middleman@lifescipublicrelations.com
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