Reata Announces First Patient Enrolled in Phase 3 FALCON Trial of Bardoxolone Methyl for the Treatment of Autosomal Dominant ...
May 30 2019 - 6:45AM
Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage
biopharmaceutical company, today announced the enrollment of the
first patient in the Phase 3 FALCON trial of bardoxolone methyl
(bardoxolone) in patients with autosomal dominant polycystic kidney
disease (ADPKD).
FALCON is an international, multi-center,
randomized, double-blind, placebo-controlled trial studying the
safety and efficacy of bardoxolone in approximately 300 patients
with ADPKD randomized evenly to active drug or placebo. The trial
will enroll a broad range of patients from 18 to 70 years old with
an estimated glomerular filtration rate (eGFR) between 30 to 90
mL/min/1.73 m². The primary efficacy endpoint for FALCON is the
change from baseline in eGFR compared to placebo after 48 weeks of
treatment followed by a 4-week drug withdrawal period, which is
also known as the retained eGFR benefit. Based upon guidance from
the United States Food and Drug Administration (FDA), an analysis
of retained eGFR demonstrating an improvement versus placebo after
one year of bardoxolone treatment may support accelerated approval,
and an improvement versus placebo after two years of treatment may
support full approval.
“ADPKD is the most common inherited form of
chronic kidney disease, and despite standard of care treatment,
approximately 50% of these patients will progress to end-stage
kidney disease by 60 years of age,” said Warren Huff, Reata’s Chief
Executive Officer and President. “We observed significant
improvements in kidney function in the ADPKD cohort of the Phase 2
PHOENIX study, and historically we have observed strong
correlations between changes in eGFR after 12 weeks of bardoxolone
treatment and one-year retained eGFR benefit in other forms of
chronic kidney disease. We are hopeful that bardoxolone may serve
as a meaningful new treatment option for patients with ADPKD.”
About Autosomal Dominant Polycystic
Kidney Disease
ADPKD is a genetic form of chronic kidney
disease (CKD) caused by mutations in PKD1 and PKD2 genes leading to
the formation of fluid-filled cysts in the kidneys and other
organs. The cysts continue to grow and can cause the kidneys to
expand up to five to seven times their normal volume leading to
pain and progressive loss of kidney function. As in other forms of
CKD, decreased mitochondrial function and chronic inflammation are
key drivers of disease progression.
ADPKD affects both men and women of all racial
and ethnic groups and is the leading inheritable cause of kidney
failure with an estimated diagnosed population of 140,000 patients
in the United States. As an autosomal dominant disease, an affected
parent has a 50% chance of passing ADPKD on to their children.
Despite current standard of care treatment, an estimated 50% of
ADPKD patients progress to end-stage kidney disease and require
dialysis or a kidney transplant by 60 years of age.
About Bardoxolone
Bardoxolone is an experimental, oral, once-daily
activator of Nrf2, a transcription factor that induces molecular
pathways that restore mitochondrial function, reduce oxidative
stress, and inhibit pro-inflammatory signaling. The FDA has granted
orphan drug designation to bardoxolone for the treatment of Alport
syndrome and pulmonary arterial hypertension. The European
Commission has granted orphan drug designation to bardoxolone for
the treatment of Alport syndrome. In addition to FALCON,
bardoxolone is currently being studied in CARDINAL, a Phase 3 study
for the treatment of Alport syndrome, CATALYST, a Phase 3 study for
the treatment of connective tissue disease-associated pulmonary
arterial hypertension, and AYAME, a Phase 3 study for the treatment
of diabetic kidney disease in Japan. AYAME is being conducted by
our licensee Kyowa Hakko Kirin Co., Ltd.
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
restores mitochondrial function, reduces oxidative stress, and
inhibits pro-inflammatory signaling. Bardoxolone and
omaveloxolone are investigational drugs, and their safety and
efficacy have not been established by any agency.
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 United States
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) 865-2219https://www.reatapharma.com
Investors:Vinny JindalVice
President, Strategy(469) 374-8721ir@reatapharma.com
Media:Matt Middleman,
M.D.LifeSci Public Relations(646)
627-8384matt.middleman@lifescipublicrelations.com
Reata Pharmaceuticals (NASDAQ:RETA)
Historical Stock Chart
From Aug 2024 to Sep 2024
Reata Pharmaceuticals (NASDAQ:RETA)
Historical Stock Chart
From Sep 2023 to Sep 2024