Reata Provides Program Update on Phase 2 Rare Renal Clinical Trials
February 27 2018 - 4:15PM
First patient enrolled for all cohorts of
PHOENIX
Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (Reata or Company), a
clinical-stage biopharmaceutical company, today provided guidance
on the timing of data announcements from the ongoing Phase 2
PHOENIX and CARDINAL trials of bardoxolone methyl (“bardoxolone”)
in rare forms of chronic kidney disease (“CKD”).
The Phase 2 PHOENIX program is studying
bardoxolone in patients with autosomal dominant polycystic kidney
disease (“ADPKD”), IgA nephropathy, focal segmental
glomerulosclerosis (“FSGS”), and CKD associated with type 1
diabetes. Approximately 25 patients per cohort will receive
bardoxolone open-label, orally, once-daily for 12 weeks. The
purpose of this study is to determine the safety and efficacy of
bardoxolone, and the primary efficacy endpoint is change from
baseline in eGFR after 12 weeks of treatment. Each cohort of
patients is being independently enrolled and analyzed, and each has
now enrolled at least one patient. The Company anticipates
that initial data from one or more PHOENIX cohorts will be released
during the second half of 2018.
CARDINAL is a Phase 2/3 study of bardoxolone in
patients with CKD caused by Alport syndrome. The Phase 2
portion of CARDINAL enrolled a total of 30 patients to assess the
safety and efficacy of once-daily, oral administration of
bardoxolone, and its primary efficacy endpoint was change from
baseline in estimated glomerular filtration rate (eGFR) at week
12. Full primary endpoint results from the study were
reported in November 2017 after all patients had reached week
12. Patients remain in the study for up to two years, and
eGFR will be measured at 52 weeks following 48 weeks of treatment
and 4 weeks of drug withdrawal (“retained benefit”). The
Company expects to report the week 52 retained benefit analysis
from this study in the third quarter of this year.
Results from the 52-week retained benefit
analysis are relevant to the ongoing Phase 3 portion of CARDINAL, a
double-blind, placebo-controlled trial enrolling up to 150 patients
worldwide. This Phase 3 study can support accelerated
approval by the FDA based upon an improvement in eGFR following 48
weeks of once-daily treatment and 4 weeks of drug withdrawal.
After this retained benefit analysis, patients will continue on
their original study treatment for another 48 weeks, and full
approval can be supported by a retained benefit at 104 weeks
following a second 4-week drug withdrawal. Prior trials in
patients with other forms of CKD have demonstrated that
improvements in eGFR are durable for up to two years, and the
change in eGFR after 12 weeks correlates with changes at one year
on-treatment and post-withdrawal.
“Diverse forms of CKD are driven by a common
final set of inflammatory pathways that bardoxolone targets,” said
Colin Meyer, M.D., Chief Medical Officer of Reata. “Treatment
with bardoxolone has resulted in clinically meaningful increases in
kidney function in patients with Alport syndrome, CKD caused by
type 2 diabetes, and CKD associated with pulmonary hypertension,
and we hope to demonstrate similar efficacy in these additional
types of CKD being studied in PHOENIX. We anticipate that
bardoxolone may complement commonly used therapies that modestly
affect progression in these diseases, which have no FDA-approved
treatments.”
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. In addition to
CARDINAL and PHOENIX, bardoxolone methyl is currently being studied
in CATALYST, a Phase 3 study for the treatment of connective tissue
disease associated pulmonary arterial hypertension. The FDA
has granted orphan designation to bardoxolone methyl for the
treatment of Alport syndrome and 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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