Reata Announces Top-Line Data from the Dose-Escalation Cohorts of the Phase 2 Motor Study of Omaveloxolone in Patients With M...
March 01 2018 - 5:14PM
Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (Reata or Company), a
clinical-stage biopharmaceutical company, today announced top-line
data from the dose-escalation cohorts of the Phase 2 MOTOR trial of
omaveloxolone for the treatment of patients with mitochondrial
myopathies. This 12-week, exploratory, dose-ranging trial
enrolled 53 patients across six dose levels. The purpose of
the first-in-patient MOTOR trial was to evaluate initial safety,
efficacy, pharmacokinetics, and pharmacodynamics of omaveloxolone
in this patient population.
The sample size of six to ten patients
randomized to omaveloxolone and two to three randomized to placebo
for safety controls at each dose level was based upon a traditional
dose-escalation design. The small number of patients at each
dose was not expected to fully characterize safety, efficacy, or
pharmacodynamics, but rather to inform the data safety monitoring
board and Reata of the appropriate dose to select for future
study. The optimal dose of omaveloxolone associated with
robust Nrf2 induction and improvement in markers of mitochondrial
function was determined to be 160 mg. At this dose,
significant, placebo-corrected improvements were noted in Nrf2
biomarkers.
Clinical activity was assessed under maximal and
submaximal conditions. The maximal exercise and 6-minute walk
tests were used to determine peak workload and 6-minute walk
distance, which reflect exercise capacity during maximal
exertion. The submaximal exercise test measured mitochondrial
function under submaximal conditions that reflect exertion levels
during normal activities of daily living. Heart rate and
blood lactate levels increase as mitochondrial function and aerobic
capacity are depleted, and these were the two key parameters that
were assessed during the submaximal exercise test.
Clinical activity was observed during submaximal
but not maximal exercise testing. Omaveloxolone did not
improve peak work or 6-minute walk distance versus placebo, which
were the primary and secondary endpoints of the trial.
However, in the submaximal exercise test, which is a more sensitive
assessment of mitochondrial function, a significant lowering of
heart rate and blood lactate levels versus placebo was observed.
At Week 12, patients treated with 160 mg of omaveloxolone
demonstrated a placebo-corrected reduction in heart rate of 12.0
beats per minute (p=0.01) and blood lactate of 1.3 mM (p=0.04) at
the end of the test (omaveloxolone, n=10; placebo, n=13). The
decrease in heart rate and lactate levels produced by omaveloxolone
are indicative of improved mitochondrial function.
The trial was overseen by an independent data
safety monitoring board, which identified no safety concerns.
“In patients with mitochondrial disease, an
important goal of interventional therapy is lowering perceived
effort during every day activities of daily living,” said Professor
John Vissing, M.D., DMSci, Director, Neuromuscular Clinic and
Research Unit at the University of Copenhagen. “By improving
oxidative capacity, omaveloxolone lowered heart rate during
submaximal exercise, which is a major achievement towards this
goal. Likewise, lowering lactate production with
omaveloxolone treatment reflects better mitochondrial function,
which supports further investigation of omaveloxolone for treatment
of patients with mitochondrial diseases.”
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 has granted
orphan designation 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
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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