RedHill Biopharma to Host Conference Call on Successful Phase III Top-Line Results with BEKINDA® for Acute Gastroenteritis
19 June 2017 - 8:00PM
RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL)
(“RedHill” or the “Company”), a specialty biopharmaceutical company
primarily focused on late clinical-stage development and
commercialization of proprietary, orally-administered, small
molecule drugs for gastrointestinal and inflammatory diseases and
cancer, today announced that the Company will host a conference
call to review the recently announced successful Phase III GUARD
study top-line results with BEKINDA® (RHB-102)1 for acute
gastroenteritis and gastritis.
RedHill announced last week that the Phase III
GUARD study with BEKINDA® 24 mg successfully met its primary
endpoint of efficacy in treatment of acute gastroenteritis, and
that BEKINDA® was found to be safe and well tolerated in this
indication.
The conference call and webcast call will be
held on Wednesday June 21, 2017 at 8:00 a.m.
EDT.
The conference call,
including a slide presentation, will be
broadcasted live and available for replay on the Company's
website, http://ir.redhillbio.com/events.cfm, for 30
days. Please access the Company's website at least 15 minutes ahead
of the conference call to register, download, and install any
necessary audio software.
Participants who wish to ask questions
during the event can do so by telephone. To participate in
the conference call, please dial the following numbers 5-10 minutes
prior to the start of the call: United States:
+1-877-280-1254; International: +1-646-254-3362; and Israel:
+972-3-763-0147. The access code for the call is
1536634.
About
BEKINDA® (RHB-102):BEKINDA® is
a proprietary, bimodal extended-release (24 hours) oral pill
formulation of ondansetron, covered by several issued and pending
patents. Successful top-line results from a Phase III clinical
study of BEKINDA® 24 mg in the U.S. for acute gastroenteritis
and gastritis (the GUARD study) were announced in June 2017. A
Phase II study with BEKINDA® 12 mg is ongoing in the U.S. for the
treatment of diarrhea-predominant irritable bowel syndrome (IBS-D),
with patient enrollment completed and top-line results expected in
September 2017.
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
promotes two gastrointestinal products in the U.S. -
Donnatal®, a prescription oral adjunctive drug
used in the treatment of IBS and acute enterocolitis, and
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)
TALICIA™ (RHB-105)
- an oral combination therapy for the treatment of
Helicobacter pylori infection with successful results from a first
Phase III study and an ongoing confirmatory 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 successful top-line results in
a 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.
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.
1 BEKINDA® is an investigational new drug,
not available for commercial distribution.
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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