Reata Pharmaceuticals, Inc. Presents Interim Phase 1b Data for Omaveloxolone in the Treatment of Unresectable or Metastatic M...
December 11 2017 - 7:30AM
Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (“Reata” or “the
Company”), a clinical-stage biopharmaceutical company, today
announced the presentation of interim data from the ongoing Phase
1b portion of the REVEAL study of omaveloxolone in combination with
approved checkpoint inhibitor (CI) therapies, ipilimumab or
nivolumab, for the treatment of Stage III or IV unresectable or
metastatic melanoma. The data were presented in an oral
presentation at the European Society for Medical Oncology (ESMO)
Immuno Oncology Congress 2017 in Geneva, Switzerland by lead author
Dr. Sapna Patel, Assistant Professor, Department of Melanoma
Medical Oncology, University of Texas MD Anderson Cancer Center.
All enrolled patients were required to have
biopsy positive inducible nitric oxide synthase (iNOS), which is an
independent predictor of poor survival in melanoma patients.
Emerging translational data suggest that iNOS is a key mediator of
myeloid-derived suppressor cells (MDSCs), whose presence has been
shown to correlate with reduced activity of CIs. Of the 30
patients enrolled in REVEAL with evaluable tumor restaging, 7/30
(23%) of patients were checkpoint inhibitor-naïve, while 23/30
(77%) of patients were refractory to prior checkpoint inhibitor
therapy. The overall response rate (confirmed + unconfirmed)
observed in all evaluable patients was 8/30 (27%, 6 partial
responses (PR) and 2 complete responses (CR)).
In CI-naïve patients, 4/7 (57%) had objective
responses including 1 CR. 3/18 (17%) patients treated with
omaveloxolone + nivolumab who were refractory to prior checkpoint
inhibitor therapies had objective responses, including 1 CR.
The majority of responses have been durable and are
ongoing. Omaveloxolone treatment was associated with
decreases in tumor iNOS, programmed death ligand 1 (PD-L1), and
indoleamine 2,3-dioxygenase (IDO-1) expression. No serious AEs
considered related to omaveloxolone have been reported to date.
Commonly reported treatment-related adverse events included
fatigue, nausea, pruritus, transaminase increases, and decreased
appetite.
“The ongoing REVEAL trial data suggests that
omaveloxolone may have activity in patients who are refractory to
checkpoint inhibitors, which is an emerging and large unmet need,”
said Colin Meyer, M.D., Chief Medical Officer of Reata. “We
are continuing with the dose escalation phase of the study to
identify the optimal dose, and upon completion, we will determine
the next steps in the clinical development program for
omaveloxolone in melanoma.”
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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