Reata Announces New Preclinical Data Demonstrating the Potential of Omaveloxolone in the Treatment of Friedreich’s Ataxia a...
April 24 2018 - 4:15PM
Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (Reata or Company), a
clinical-stage biopharmaceutical company, today announced new
preclinical data demonstrating that omaveloxolone potently
activates the Keap1/Nrf2 pathway, significantly reduces production
of reactive oxygen species, and improves mitochondrial function in
two different models of severe neurological diseases. These
results support the rationale for clinical studies of omaveloxolone
in neurodegenerative and neuromuscular disorders, including the
ongoing pivotal MOXIe trial in patients with Friedreich’s ataxia.
In one study, omaveloxolone treatment
dose-dependently increased the expression of key Nrf2 target genes,
decreased LPS-induced expression of pro-inflammatory genes, and
improved mitochondrial function in several cell lines including
hFXN154F mouse embryonic fibroblasts expressing a mutant human
frataxin gene. These data were presented by Christian Wigley,
Ph.D., Reata’s Vice President of Research, at the ongoing 2018
American Academy of Neurology Annual Meeting in Los Angeles,
CA.
In a separate study, independent academic
researchers from University College London, University of Dundee,
Tohoku University, Johns Hopkins University, and University of
Muenster studied the effect of omaveloxolone treatment in a rodent
model of epileptogenesis and chronic seizures resulting from kainic
acid-induced status epilepticus. Acute treatment with
omaveloxolone significantly and dose-dependently increased
glutathione and ATP levels, prevented neuronal loss, and reduced
the median frequency of late spontaneous seizures by 94%.
Additionally, in vitro results from a mixed cortical neuronal cell
culture demonstrated that omaveloxolone treatment improved
mitochondrial metabolism, reduced production of reactive oxygen
species, and prevented neuronal cell death. These results were
recently published in an original research article titled, “KEAP1
inhibition is neuroprotective and suppresses the development of
epilepsy” in Brain, a Journal of Neurology. The article can
be found online at the following link:
https://doi.org/10.1093/brain/awy071.
“These studies add to the growing body of
clinical and preclinical data demonstrating that omaveloxolone’s
mechanism of action has the potential to address a broad range of
neurological and neuromuscular diseases,” said Keith Ward, Ph.D.,
Reata’s Chief Development Officer. “We are especially
encouraged by the significant improvements in mitochondrial
function and reduction in reactive oxygen species observed in these
studies, as these are both known key drivers of pathogenesis in
Friedreich’s ataxia.”
About Friedreich's Ataxia
Friedreich's ataxia is a rare, degenerative,
life-shortening neuromuscular 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 Friedreich's ataxia.
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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