FDA Confirms That Use of mFARS as Primary Endpoint in Part 2 of the MOXIe Trial Can Support Approval of Omaveloxolone in Frie...
August 14 2017 - 7:00AM
Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (“Reata” or the
“Company”), a clinical-stage biopharmaceutical company, today
announced that the U.S. Food and Drug Administration (FDA)
confirmed that the modified Friedreich’s Ataxia Rating Scale
(mFARS) is an acceptable primary endpoint for Part 2 of the MOXIe
trial for omaveloxolone in Friedreich’s ataxia (FA).
The FDA communication was made in response to the Company’s
request that the FDA confirm its prior guidance that, depending on
the MOXIe trial results, mFARS could be appropriate to support
approval of omaveloxolone for FA under Subpart H. In the
recent communication, FDA indicated that it may consider either
accelerated or full approval based on the overall results of the
trial and strength of the data. FDA also recommended that the
Company extend the treatment duration for Part 2 of the study and
add a straightforward patient-reported or performance-based outcome
endpoint to the study.
“This communication from the FDA confirms our view that mFARS
could support approval in Friedreich’s ataxia, and we believe that
it leaves open an opportunity for full approval if the trial
produces robust clinical results,” said Colin Meyer, Chief Medical
Officer of Reata. “We remain committed to rapidly advancing
omaveloxolone so that it could be the first approved treatment for
this serious, debilitating, and life-shortening condition.”
Part 2 of the MOXIe trial will be a double-blind, randomized,
placebo-controlled, multi-center, international trial designed to
evaluate the safety, tolerability, and efficacy of omaveloxolone in
patients with FA. The trial will enroll approximately 100 FA
patients randomized evenly to either 150 mg of omaveloxolone or
placebo. The primary endpoint of the trial will be the change
from baseline in mFARS of omaveloxolone compared to placebo at 48
weeks. Additional endpoints will include the change from
baseline in peak work during maximal exercise testing, Patient
Global Impression of Change, and Clinical Global Impression of
Change. The Company has initiated screening patients for Part
2 of MOXIe and plans to randomize the first patient during the
second half of 2017.
About Friedreich's Ataxia
FA is a rare, degenerative, life-shortening neuro-muscular
disorder that affects children and adults and involves the loss of
strength and coordination usually leading to wheelchair use;
diminished vision, hearing and speech; scoliosis (curvature of the
spine); increased risk of diabetes; and a life-threatening heart
condition. Currently, there are no FDA-approved treatments
for 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 to restore mitochondrial function, reduce oxidative stress,
and resolve inflammation.
Forward-Looking Statements
This press release includes certain disclosures
which 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) 865-2219
info@reatapharma.com
http://news.reatapharma.com
Investor Relations:
Vinny Jindal
Vice President, Strategy
(855) 55-REATA
ir@reatapharma.com
Media:
Matt Middleman, M.D.
LifeSci Public Relations
(646) 627-8384
matt.middleman@lifescipublicrelations.com
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