Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage
biopharmaceutical company, today announced that it has completed a
successful end-of-Phase 2 meeting with the United States Food and
Drug Administration (FDA) regarding the design of a Phase 3
clinical trial of bardoxolone methyl (bardoxolone) in patients with
autosomal dominant polycystic kidney disease (ADPKD).
The trial, named FALCON, will be an
international, double-blind, placebo-controlled, parallel group,
Phase 3 trial. The Company plans to enroll approximately 300
ADPKD patients randomized 1:1 to oral, once-daily bardoxolone or
placebo. The trial will include ADPKD 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 is the change from baseline in eGFR compared to placebo
after 48 weeks of treatment followed by a 4-week drug withdrawal
period, the retained eGFR benefit.
FALCON is statistically powered to detect a
placebo-corrected, retained eGFR benefit of 1.6 mL/min/1.73
m2. Based upon guidance from the FDA, the 52-week retained
eGFR benefit data may support accelerated approval under subpart
H. After Week 52, patients will be restarted on study drug
with their original treatment assignments and will continue on
study for a second year. The second-year retained eGFR
benefit will be measured at Week 104 after withdrawal of drug for
four weeks. Based upon guidance from the FDA, the year-two
retained eGFR benefit data may support full approval.
The Company expects to initiate enrollment in
the FALCON trial during mid-2019.
“The meaningful improvements in kidney function
and quality of life observed in the ADPKD cohort of the Phase 2
PHOENIX trial give us confidence that bardoxolone may become an
important treatment option for patients with ADPKD,” said Colin
Meyer, M.D., Reata’s Chief Medical Officer. “FALCON closely
mirrors the design of CARDINAL, our ongoing Phase 3 study of
bardoxolone in Alport syndrome patients. This should allow us
to leverage our operational expertise and investigator network to
efficiently enroll and execute the trial. Additionally, the
acceptance of retained eGFR benefit after a 4-week withdrawal
period for a second bardoxolone chronic kidney disease (CKD) trial
further validates it as the appropriate approval endpoint for
bardoxolone in pivotal trials for rare forms of CKD.”
Reata management will host a conference call and
webcast to discuss the FALCON clinical trial design on Thursday,
January 3, 2019, at 4:30 p.m. ET at the following:
CONFERENCE CALL INFORMATION |
Date: |
Thursday, January 3, 2019 |
Time: |
4:30 p.m. ET |
Audience Dial-in (toll-free): |
(844) 348-3946 |
Audience Dial-in (international): |
(213) 358-0892 |
Conference ID: |
8078409 |
Webcast Link: |
https://edge.media-server.com/m6/p/23y2d7it |
About Autosomal Dominant Polycystic
Kidney Disease
ADPKD is a genetic form of 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 116,000 patients
in the United States. As an autosomal dominant disease, an
affected parent has a 50% chance of passing ADPKD on to their
children. An estimated 50% of ADPKD patients progress to
end-stage kidney disease and require dialysis or a kidney
transplant by 60 years of age despite current standard of care
treatment.
About Bardoxolone
Bardoxolone is an experimental, oral, once-daily
activator of Nrf2, a transcription factor that promotes the
resolution of inflammation by restoring mitochondrial function,
reducing oxidative stress, and inhibiting pro-inflammatory
signaling. The FDA has granted Orphan Drug designation in the
United States to bardoxolone for the treatment of Alport syndrome
and pulmonary arterial hypertension. The European Commission
has granted Orphan Drug designation in Europe 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 CKD caused by Alport syndrome, CATALYST, a
Phase 3 study for the treatment of connective tissue disease
associated pulmonary arterial hypertension, AYAME, a Phase 3 study
for the treatment of diabetic kidney disease being conducted in
Japan by Reata’s licensee, Kyowa Hakko Kirin Co. Ltd., and PHOENIX,
a Phase 2 study of bardoxolone for the treatment of ADPKD, IgA
nephropathy, focal segmental glomerulosclerosis, and CKD associated
with type 1 diabetes.
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
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