Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage
biopharmaceutical company, today announced that four abstracts
highlighting Reata’s progress in developing bardoxolone methyl
(bardoxolone) for the treatment of chronic kidney disease (CKD)
will be presented at the 56th Congress of the European Renal
Association and European Dialysis and Transplant Association
(ERA-EDTA). The Congress will take place on June 13 - 16, 2019 in
Budapest, Hungary.
An oral presentation will discuss molecular
insights into the effects of bardoxolone in cellular models of
polycystic kidney disease (PKD), including data demonstrating that
bardoxolone reduces cyst formation in cellular models of PKD. The
poster presentations will include baseline characteristics for the
Phase 3 portion of CARDINAL, a Phase 2/3 study of bardoxolone for
the treatment of Alport syndrome, and safety and efficacy data from
the Phase 2 PHOENIX study of bardoxolone in patients with rare
forms of CKD. One PHOENIX poster will discuss data from the focal
segmental glomerulosclerosis (FSGS) cohort of PHOENIX, and the
other will discuss data from all four cohorts of PHOENIX.
Abstracts to be presented are summarized
below.
Title: The Nrf2 Activator
Bardoxolone Methyl Inhibits Cyst Formation, Reduces Inflammation,
and Improves Mitochondrial Function in Cellular Models of
Polycystic Kidney DiseasePresenter: Christian
Wigley, Ph.D., Reata's Vice President of
ResearchOral: Friday, June 14th, 8:39 a.m. –
8:52 a.m.
Title: Baseline Characteristics
in the “CARDINAL” Trial: A Phase 3 Study of the Efficacy and Safety
of Bardoxolone Methyl in Patients with Alport
SyndromePresenter: Bertrand Knebelmann, M.D.,
Division de Néphrologie, Hôpital Necker, Assistance
Publique-Hôpitaux de Paris, Paris, FrancePoster
FP179: Friday, June 14th, 9:30 a.m. – 10:45 a.m. and
4:30 p.m. – 5:00 p.m.
Title: Safety and Efficacy
of Bardoxolone Methyl in Patients with Rare Chronic Kidney
DiseasesPresenter: Pablo E. Pergola, M.D., Ph.D.,
Research Director, Renal Associates, PA, San Antonio,
TXPoster FP117: Friday, June 14th, 9:30 a.m.
– 10:45 a.m. and 4:30 p.m. – 5:00 p.m.
Title: Safety and Efficacy
of Bardoxolone Methyl in Patients with Focal Segmental
GlomerulosclerosisPresenter: Pablo E. Pergola,
M.D., Ph.D., Research Director, Renal Associates, PA, San Antonio,
TXPoster FP152: Friday, June 14th, 9:30 a.m.
– 10:45 a.m. and 4:30 p.m. – 5:00 p.m.
About Bardoxolone
Bardoxolone is an experimental, oral, once-daily
activator of Nrf2, a transcription factor that induces molecular
pathways that promote restoration of mitochondrial function,
reduction of oxidative stress, and inhibition of pro-inflammatory
signaling. The United States Food and Drug Administration 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 CARDINAL,
bardoxolone is currently being studied in FALCON, a Phase 3 study
for the treatment of autosomal dominant polycystic kidney disease
(ADPKD), 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. The Phase 2 PHOENIX program studied bardoxolone in
patients with ADPKD, FSGS, IgA nephropathy, and type 1 diabetic
CKD. PHOENIX is complete, and results from all four cohorts have
now been released.
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 restoration of mitochondrial function, reduction of
oxidative stress, and inhibition of 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 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) 865-2219https://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 Mar 2024 to Apr 2024
Reata Pharmaceuticals (NASDAQ:RETA)
Historical Stock Chart
From Apr 2023 to Apr 2024