Reata Announces Publication of Results From Pivotal Moxie Trial of Omaveloxolone in Patients with Friedreich’s Ataxia
October 26 2020 - 7:00PM
Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,”
or “we”), a clinical-stage biopharmaceutical company, today
announced that results from the pivotal part 2 portion of the MOXIe
trial evaluating the efficacy and safety of omaveloxolone in
patients with Friedreich’s ataxia (“FA”) were published in the
journal
Annals of Neurology.
MOXIe was a randomized, double-blind,
placebo-controlled study, and patients with genetically confirmed
FA and baseline modified Friedreich’s Ataxia Rating Scale (mFARS)
scores between 20 and 80 were randomized 1:1 to receive placebo or
150 mg of omaveloxolone daily. The primary endpoint was change from
baseline in mFARS score at 48 weeks. Patients treated with
omaveloxolone experienced a statistically significant,
placebo-corrected mean improvement in mFARS of 2.40 points after 48
weeks of treatment (p=0.014). Omaveloxolone was generally reported
to be well tolerated in this study.
The publication entitled “Safety and Efficacy of
Omaveloxolone in Friedreich’s Ataxia (MOXIe Study)” can be accessed
online at https://doi.org/10.1002/ana.25934.
About Friedreich's Ataxia
FA is an inherited, debilitating, and
degenerative neuromuscular disorder that is typically diagnosed
during adolescence and can ultimately lead to premature death.
Patients with FA experience progressive loss of coordination,
muscle weakness, and fatigue, which commonly progresses to motor
incapacitation and wheelchair reliance. Symptoms generally occur in
children, with patients requiring a wheelchair by their teens or
early 20s. FA affects approximately 5,000 children and adults in
the United States and 22,000 globally. Currently, there are no
treatments approved by the U.S. Food and Drug Administration
(“FDA”) for FA.
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 FDA and the European
Commision have granted orphan drug 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
(“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.
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 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) 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 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) 865-2219https://www.reatapharma.com/contact-us/
Investor Relations:Vinny
JindalVice President, Investor Relations and Corporate
Communications(469)
374-8721ir@reatapharma.comhttps://www.reatapharma.com/
Reata Pharmaceuticals (NASDAQ:RETA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Reata Pharmaceuticals (NASDAQ:RETA)
Historical Stock Chart
From Apr 2023 to Apr 2024