RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) (“RedHill” or the
“Company”), a specialty biopharmaceutical company primarily focused
on the development and commercialization of late clinical-stage,
proprietary, orally-administered, small molecule drugs for
gastrointestinal and inflammatory diseases and cancer, today
announced the presentation of a poster at Digestive Disease Week
(DDW) 2017. The poster (presentation number: Sa1200) will be
presented by Ira Kalfus, MD, Medical Director at RedHill, on
Saturday, May 6, 2017 from 12:00 PM to 2:00 PM CDT, in Chicago, IL.
The poster1 presentation, entitled
“ERADICATE Hp: A Randomized, Double-Blind, Placebo-Controlled Phase
III Study to Assess the Safety and Efficacy of Rifabutin Triple
Therapy (RHB-105) for Helicobacter pylori (H. pylori) Infection in
Dyspepsia Patients” describes the previously reported positive
final results of the ERADICATE Hp first Phase III study with
RHB-105 for H. pylori infection.
RHB-105 is a proprietary, fixed-dose, oral
combination therapy for the eradication of H.
pylori infection.
The ERADICATE Hp first Phase III study with
RHB-105 successfully met its protocol-defined mITT primary endpoint
of superiority over historical standard-of-care (SoC) eradication
rate of 70%, with high statistical significance (p<0.001). The
study results demonstrated 89.4% efficacy in eradicating H.
pylori infection with RHB-105. Notably, the 89.4% efficacy in
eradicating H. pylori infection with RHB-105 was also superior
to subsequent open-label treatment with SoC therapies of patients
in the placebo arm of the ERADICATE Hp study, which demonstrated
63% eradication rate in the mITT population (p=0.006), further
supporting the potential efficacy of RHB-105 as a treatment for H.
pylori infection. Treatment with RHB-105 appeared to be safe
and well tolerated.
A confirmatory Phase III study is planned to be
initiated in the second quarter of 2017. The two-arm, randomized,
double-blind, active comparator confirmatory Phase III study will
compare RHB-105 against a dual therapy amoxicillin and omeprazole
regimen at equivalent doses. The study is planned to enroll
approximately 440 patients in up to 55 clinical sites in the
U.S.
Subject to its successful completion, the
planned confirmatory Phase III study, along with the results from
the successfully completed first Phase III ERADICATE Hp study with
RHB-105 and data to be obtained from an ongoing supportive PK
program, are expected to support a U.S. New Drug Application (NDA)
for RHB-105.
About RHB-105:RHB-105 is a new
and proprietary fixed-dose oral combination therapy of two
antibiotics and a proton pump inhibitor (PPI) in an all-in-one oral
capsule with a planned indication for the treatment of H.
pylori infection. H. pylori bacterial infection is a
major cause of chronic gastritis, peptic ulcer disease, gastric
cancer and mucosa-associated lymphoid tissue (MALT) lymphoma. A
first Phase III study with RHB-105 was completed in the U.S. with
positive results (ERADICATE Hp study). The study demonstrated an
overall success rate of 89.4% in eradicating H. pylori, and met its
protocol-defined primary endpoint of superiority in eradication
of H. pylori infection over historical standard-of-care
efficacy levels of 70%, with high statistical significance
(p<0.001). A confirmatory Phase III study is planned to be
initiated in the U.S in the second quarter of 2017. Additional
studies may be required, subject to FDA review. RHB-105 has been
granted Qualifying Infectious Disease Product (QIDP) designation by
the FDA, providing a Fast-Track development pathway, as well as NDA
Priority Review status, potentially leading to a shorter NDA review
time by the FDA, if filed. If approved, RHB-105 will also receive
an additional five years of exclusivity, in addition to the
standard exclusivity period, for a total of 8 years of U.S. market
exclusivity.
About RedHill Biopharma
Ltd.:RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock
Exchange:RDHL) is a specialty biopharmaceutical company
headquartered in Israel, primarily focused on the development and
commercialization of late clinical-stage, proprietary,
orally-administered, small molecule drugs for the treatment of
gastrointestinal and inflammatory diseases and cancer. RedHill has
a U.S. co-promotion agreement with Concordia for
Donnatal®, a prescription oral adjunctive drug
used in the treatment of IBS and acute enterocolitis, as well as an
exclusive license agreement with Entera Health for
EnteraGam®, a medical food intended for the
dietary management, under medical supervision, of chronic diarrhea
and loose stools. RedHill’s clinical-stage pipeline includes: (i)
RHB-105 - an oral combination
therapy for the treatment of Helicobacter pylori infection with
successful results from a first Phase III study; (ii)
RHB-104 - an oral combination
therapy for the treatment of Crohn's disease with an ongoing first
Phase III study, a completed proof-of-concept Phase IIa study for
multiple sclerosis and QIDP status for nontuberculous mycobacteria
(NTM) infections; (iii) BEKINDA®
(RHB-102) - a once-daily oral
pill formulation of ondansetron with an ongoing Phase III study for
acute gastroenteritis and gastritis and an ongoing Phase II study
for IBS-D; (iv) RHB-106 - an
encapsulated bowel preparation licensed to Salix Pharmaceuticals,
Ltd.; (v) YELIVA® (ABC294640) - a
Phase II-stage, orally-administered, first-in-class SK2 selective
inhibitor targeting multiple oncology, inflammatory and
gastrointestinal indications; (vi) MESUPRON - a
Phase II-stage first-in-class, orally-administered protease
inhibitor, targeting pancreatic cancer and other solid tumors and
(vii) RIZAPORT® (RHB-103) - an oral thin film
formulation of rizatriptan for acute migraines, with a U.S. NDA
currently under discussion with the FDA and marketing authorization
received in two EU member states under the European Decentralized
Procedure (DCP). More information about the Company is available
at: www.redhillbio.com.
1 The poster was authored by Ira N. Kalfus,
MD, Medical Director, RedHill Biopharma; Gilead Raday, Chief
Operating Officer, RedHill Biopharma; Reza Fathi, PhD, Senior VP
R&D, RedHill Biopharma and David Y. Graham, MD, Professor of
Medicine, Molecular Virology and Microbiology, Baylor College of
Medicine.
This press release contains “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. Such statements may be preceded by the words
“intends,” “may,” “will,” “plans,” “expects,” “anticipates,”
“projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,”
“potential” or similar words. Forward-looking statements are based
on certain assumptions and are subject to various known and unknown
risks and uncertainties, many of which are beyond the Company’s
control, and cannot be predicted or quantified and consequently,
actual results may differ materially from those expressed or
implied by such forward-looking statements. Such risks and
uncertainties include, without limitation, risks and uncertainties
associated with (i) the initiation, timing, progress and results of
the Company’s research, manufacturing, preclinical studies,
clinical trials, and other therapeutic candidate development
efforts; (ii) the Company’s ability to advance its therapeutic
candidates into clinical trials or to successfully complete its
preclinical studies or clinical trials; (iii) the extent and number
of additional studies that the Company may be required to conduct
and the Company’s receipt of regulatory approvals for its
therapeutic candidates, and the timing of other regulatory filings,
approvals and feedback; (iv) the manufacturing, clinical
development, commercialization, and market acceptance of the
Company’s therapeutic candidates; (v) the Company’s ability to
successfully market Donnatal® and EnteraGam®, (vi) the Company’s
ability to establish and maintain corporate collaborations; (vii)
the Company's ability to acquire products approved for marketing in
the U.S. that achieve commercial success and build its own
marketing and commercialization capabilities; (viii) the
interpretation of the properties and characteristics of the
Company’s therapeutic candidates and of the results obtained with
its therapeutic candidates in research, preclinical studies or
clinical trials; (ix) the implementation of the Company’s business
model, strategic plans for its business and therapeutic candidates;
(x) the scope of protection the Company is able to establish and
maintain for intellectual property rights covering its therapeutic
candidates and its ability to operate its business without
infringing the intellectual property rights of others; (xi) parties
from whom the Company licenses its intellectual property defaulting
in their obligations to the Company; and (xii) estimates of the
Company’s expenses, future revenues capital requirements and the
Company’s needs for additional financing; (xiii) competitive
companies and technologies within the Company’s industry. More
detailed information about the Company and the risk factors that
may affect the realization of forward-looking statements is set
forth in the Company's filings with the Securities and Exchange
Commission (SEC), including the Company's Annual Report on Form
20-F filed with the SEC on February 23, 2017. All forward-looking
statements included in this Press Release are made only as of the
date of this Press Release. We assume no obligation to update any
written or oral forward-looking statement unless required by
law.
Company contact:
Adi Frish
Senior VP Business Development &
Licensing
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
IR contact (U.S.):
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus@troutgroup.com
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