Bardoxolone Treatment Produced Significant
Increase in Kidney Function Maintained Through Week 36
Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (Reata or Company), a
clinical-stage biopharmaceutical company, today provided an update
on the ongoing Phase 2 CARDINAL study of bardoxolone methyl
(bardoxolone) in patients with chronic kidney disease (CKD) due to
Alport syndrome. The Phase 2 portion of CARDINAL enrolled 30
patients to receive bardoxolone orally, once-daily for two
years. Ninety percent of patients (n=27) remain on study and
will be included in the Week 52 withdrawal analysis. Complete
data are available through Week 36.
Efficacy results demonstrate that significant
increases in kidney function, as measured by estimated glomerular
filtration rate (eGFR), are maintained through Week 36. The
mean improvement from baseline in eGFR at Week 36 is 11.3
mL/min/1.73 m2 (n=27; p<0.0000001), which is not significantly
different than the change observed at Week 12. Initial
increases in urinary albumin to creatinine ratio that were due to
increases in eGFR have stabilized. Adverse events have been
generally mild to moderate in severity, and no drug-related serious
adverse events have been reported.
“Bardoxolone continues to be well-tolerated in
Alport syndrome patients as evidenced by the encouraging safety
profile and high patient retention rate in the Phase 2 cohort of
CARDINAL,” said Colin Meyer, M.D., Chief Medical Officer of
Reata. “These data demonstrate that the clinically meaningful
increases in kidney function we observed in Alport syndrome
patients after 12 weeks of treatment are durable for at least 36
weeks and consistent with our observations from prior trials of
bardoxolone in other forms of CKD. We appreciate the interest
and commitment of the Alport syndrome patient community and
CARDINAL investigators to advance our understanding of bardoxolone
in these patients with unmet need.”
Reata management will host a call to discuss
these results on Thursday, April 12th, at 8:30 a.m. ET.
CONFERENCE CALL INFORMATION |
|
Date: |
Thursday, April 12, 2018 |
Time: |
8:30AM ET |
Audience Dial-in (toll-free): |
(844)
348-3946 |
Audience Dial-in (international): |
(213)
358-0892 |
Passcode: |
6184499 |
Webcast Link: |
https://edge.media-server.com/m6/p/m4rffeqt |
|
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About the CARDINAL Clinical Study
CARDINAL is an international, multi-center,
Phase 2/3 study enrolling patients from 12 to 60 years old with a
confirmed genetic or histological diagnosis of Alport syndrome,
baseline eGFR values between 30 to 90 mL/min/1.73 m2, and on stable
renin-angiotensin-aldosterone system blockade unless
contraindicated. The Phase 2 portion of CARDINAL is
open-label and enrolled 30 patients. The Phase 3 portion of
CARDINAL is double-blind, placebo-controlled, and will randomize
approximately 150 patients on a 1:1 basis to once-daily, oral
bardoxolone or placebo.
The Phase 3 primary efficacy endpoint is the
on-treatment eGFR change from baseline in bardoxolone-treated
patients relative to placebo at Week 48. The key secondary
endpoint of the Phase 3 portion of the trial is the change from
baseline in retained eGFR benefit after 48 weeks on-treatment and
four weeks off-treatment and is designed to demonstrate that
bardoxolone has disease-modifying activity in Alport syndrome
patients. Based upon guidance from the United States Food and
Drug Administration (FDA), the 52-week retained eGFR benefit data
may support accelerated approval under subpart H. After
withdrawal, patients will be restarted on study drug with their
original treatment assignments and will continue on study for a
second year. The second year on-treatment eGFR change will be
measured after 100 weeks and the retained eGFR benefit will be
measured after withdrawal of drug for four weeks at Week 104.
Based upon guidance from the FDA, the year-two retained eGFR
benefit data may support full approval.
About Alport Syndrome
Alport syndrome is a rare, genetic form of CKD
caused by mutations in the genes encoding type IV collagen, which
is a major structural component of the glomerular basement membrane
(GBM) in the kidney. The abnormal expression of type IV
collagen causes loss of GBM integrity, abnormal leakage of proteins
through the GBM, and excessive reabsorption of protein in the
proximal tubules of the kidney. Like other forms of CKD,
excessive reabsorption of protein in the tubules induces oxidative
stress, chronic inflammation, and renal interstitial inflammation
and fibrosis.
Alport syndrome affects approximately 30,000 –
60,000 people in the United States according to the Alport Syndrome
Foundation. A majority of patients with Alport syndrome
develop end-stage renal disease, and approximately 50% of male
patients require dialysis or a kidney transplant by the age of
25. There are currently no approved therapies to treat Alport
syndrome.
About Bardoxolone
Bardoxolone 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 for the treatment of Alport syndrome and
pulmonary arterial hypertension. Bardoxolone is currently
being studied in CARDINAL, a Phase 3 study for the treatment of
Alport syndrome, 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
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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