Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage
biopharmaceutical company, announced today that the registrational
Part 2 portion of the MOXIe Phase 2 trial of omaveloxolone in
patients with Friedreich’s ataxia (FA) met its primary endpoint of
change in the modified Friedreich’s Ataxia Rating Scale (mFARS)
relative to placebo after 48 weeks of treatment. Patients
treated with omaveloxolone (150 mg/day) demonstrated a
statistically significant, placebo-corrected 2.40 point improvement
in mFARS after 48 weeks of treatment (p=0.014). Omaveloxolone
treatment was generally reported to be well-tolerated. Based
on these positive results, and subject to discussions with
regulatory authorities, the company plans to proceed with the
submission of regulatory filings for marketing approval in the
United States and internationally.
“The results of MOXIe represent a truly historic
moment for the patients, families, and caregivers that comprise the
Friedreich’s ataxia community,” said Ronald Bartek, President of
the Friedreich’s Ataxia Research Alliance (FARA). “Based on
the results reported today for omaveloxolone, we are hopeful that
our community will finally have its first approved therapy that can
slow this relentlessly progressive disease. We are extremely
proud of, and grateful for, the FA community including all those
who have participated in this clinical trial and in the natural
history study important in designing the trial. We are also
grateful to the clinical teams who conducted the trial and to our
Reata colleagues. We look forward to continuing the
Reata-FARA partnership as we work in pursuit of approval of the
first FA therapy.”
“Patients living with Friedreich’s ataxia
experience a devastating and progressive loss of neurological
function. The MOXIe trial with omaveloxolone is the first
study to demonstrate a significant improvement in neurological
function in patients with FA. We believe that the MOXIe
findings announced today bring us closer to our goal of providing
an urgently needed therapy to patients with FA,” said Warren Huff,
President and Chief Executive Officer of Reata. “On behalf of
everyone at Reata, I would like to express my sincere appreciation
to all of the patients, families, and investigators who
participated in the MOXIe study.”
Full MOXIe study results will be presented at a
future medical meeting.
Trial Overview and Results
Part 2 of MOXIe, an international, multi-center,
double-blind, placebo-controlled, randomized registrational Phase 2
trial, enrolled 103 patients with FA at 11 study sites in the
United States, Europe, and Australia and is the largest global,
interventional study ever conducted in FA. Patients were
randomized 1:1 to 150 mg of omaveloxolone or placebo. The
primary analysis population included patients without pes cavus
(n=82), a musculoskeletal foot deformity that may interfere with
the patient’s ability to perform some components of the mFARS
exam. Safety analyses were evaluated in the all randomized
population (n=103).
The primary endpoint for the study was change in
the mFARS score relative to placebo after 48 weeks of
treatment. The mFARS is a physician-assessed neurological
rating scale used to measure FA disease progression. It
includes four sections that measure the patient’s performance of
activities such as speaking and swallowing, upper limb
coordination, lower limb coordination, and standing and
walking. The United States Food and Drug Administration (FDA)
has indicated that mFARS is an acceptable primary endpoint to
evaluate the effect of omaveloxolone for the treatment of patients
with FA.
Omaveloxolone treatment met the primary endpoint
of the study producing a statistically significant,
placebo-corrected 2.40 point improvement (decrease) in mFARS (n=82;
p=0.014). Patients treated with omaveloxolone experienced a
mean improvement in mFARS of -1.55 points from baseline, while
patients treated with placebo experienced a mean worsening in mFARS
of +0.85 points from baseline. The observed placebo-corrected
improvements in mFARS were time-dependent, increasing over the
course of treatment with the largest improvement observed after 48
weeks of treatment.
Omaveloxolone treatment also improved the mFARS
scores of patients with pes cavus. When the pes cavus
patients are included in the analysis of the mFARS scores at Week
48 (the all randomized population), omaveloxolone treatment
produced a mean statistically significant, placebo-corrected 1.93
point improvement in mFARS (n=103; p=0.034). Omaveloxolone
treatment also improved several secondary endpoints included in the
study.
Omaveloxolone was generally reported to be well
tolerated in this study. Four (8%) omaveloxolone patients and
two (4%) placebo patients discontinued study drug due to an adverse
event (AE). The reported AEs were generally mild to moderate
in intensity, and the most common AEs (> 20%) observed more
frequently compared to placebo were headache, nausea, increased
aminotransferases, fatigue, and abdominal pain. Increases in
aminotransferases are a pharmacological effect of omaveloxolone,
which increases production of aminotransferases in vitro, and we
believe are related to restoration of mitochondrial function.
In MOXIe, the aminotransferase increases were associated with
improvements (reductions) in total bilirubin and were not
associated with liver injury. The overall rate of serious
adverse events (SAEs) was low, with three patients in each group
reporting SAEs while receiving study drug. Two additional
omaveloxolone-treated patients reported SAEs approximately two
weeks after receiving their final dose.
Reata management will host a call to discuss
these results tomorrow, October, 15, 2019 at 8:00 a.m. ET.
CONFERENCE CALL INFORMATION
|
Date: |
10/15/2019 |
Time: |
08:00 Eastern Time |
Audience Dial-in (toll-free): |
(844) 348-3946 |
Audience Dial-in (international): |
(213) 358-0892 |
Conference ID: |
8653916 |
Webcast Link: |
https://edge.media-server.com/mmc/p/r87cj2nt |
This press release and the management slide
presentation for the call will be available on Reata’s website
shortly before the call at http://reatapharma.com/investors/ and
will be available for 12 months after the call. The audio recording
and webcast of the call will be accessible for at least 90 days
after the call at http://reatapharma.com/investors/.
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 FDA for FA.
About Omaveloxolone
Omaveloxolone is an experimental, oral,
once-daily activator of Nrf2, a transcription factor that induces
molecular pathways that promote restoration of mitochondrial
function, reduction of oxidative stress, and inhibition of
pro-inflammatory signaling. The FDA and the European
Commission have granted orphan drug 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 (bardoxolone) and omaveloxolone, target the important
transcription factor Nrf2 that promotes restoration of
mitochondrial function, reduction of oxidative stress, and
inhibition of 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)
865-2219http://reatapharma.com
Investor Relations:Vinny JindalVice President,
Strategy(469)
374-8721ir@reatapharma.comhttp://reatapharma.com/contact-us/
Media:Matt Middleman, M.D.LifeSci Public
Relations(646)
627-8384matt.middleman@lifescipublicrelations.com
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