Reata Announces the Publication of Efficacy Data From the Beacon Study of Bardoxolone in Diabetic CKD in the American Journal...
January 18 2018 - 4:15PM
Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (“Reata” or “the
Company”), a clinical-stage biopharmaceutical company, today
announced the digital publication of an original research article,
“Bardoxolone Methyl Improves Kidney Function in Patients with
Chronic Kidney Disease Stage 4 and Type 2 Diabetes – Post-hoc
Analyses from BEACON,” in the American Journal of Nephrology.
The publication complements previously published safety
analyses and reports efficacy analyses that characterize
bardoxolone’s longer-term effects on kidney function. Key
highlights of the paper demonstrate that:
- For patients treated at least 48 weeks, increases in eGFR from
baseline and placebo were sustained 4 weeks after cessation of
treatment
- Early improvements in eGFR with bardoxolone methyl correlate
with durable increases through one year of treatment and sustained
eGFR increases after cessation of treatment
- Patients randomized to bardoxolone methyl were significantly
less likely to experience a newly validated composite renal
endpoint consisting of confirmed ≥30% decline from baseline in
eGFR, confirmed eGFR <15 mL/min/1.73 m2, and end-stage renal
disease events (hazard ratio 0.48 [95% CI 0.36 to 0.64];
p<0.0001), suggesting that bardoxolone preserves kidney function
and may delay the onset of kidney failure in patients with type 2
diabetes and stage 4 chronic kidney disease
“Though BEACON was discontinued early, it was
not a failed study, as it yielded critical insights into
bardoxolone methyl’s clinical profile,” said Glenn Chertow, M.D.,
MPH, Professor of Medicine and Chief, Division of Nephrology at
Stanford University School of Medicine. “In this post-hoc
analysis, we employed an expanded renal composite endpoint and
showed that bardoxolone methyl reduced (by half) the likelihood of
developing an adverse renal event. If the associated risks of
heart failure due to fluid overload can be mitigated, bardoxolone
methyl could prove to be an extremely valuable treatment for
diabetic kidney disease.”
“We believe the pharmacology of bardoxolone may
be broadly relevant to many forms of kidney disease, not just
diabetic CKD,” said Colin Meyer, M.D., Chief Medical Officer of
Reata. “This publication helps provide additional context and
rationale for our expanding kidney clinical programs, including our
ongoing Phase 3 trial in Alport syndrome and Phase 2 trials in
autosomal dominant polycystic kidney disease, IgA nephropathy,
focal segmental glomerulosclerosis, and type 1 diabetic CKD.”
The article can be found online at the following
link: https://www.karger.com/Article/FullText/486398.
About Bardoxolone Methyl
Bardoxolone methyl 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 bardoxolone methyl for the treatment of
Alport syndrome and pulmonary arterial hypertension.
Bardoxolone methyl is currently being studied in CARDINAL, a Phase
3 study for the treatment of Alport syndrome, PHOENIX, a Phase 2
study for the treatment of autosomal dominant polycystic kidney
disease, IgA nephropathy, CKD associated with type 1 diabetes, and
focal segmental glomerulosclerosis, and CATALYST, a Phase 3 study
for the treatment of connective tissue disease associated pulmonary
arterial hypertension.
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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