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 drugs for gastrointestinal
diseases, today announced a presentation of Phase II results of
BEKINDA® for diarrhea-predominant irritable bowel syndrome
(IBS-D) at Digestive Disease Week® (DDW) 2018, being held June 2-5
in Washington, DC.
The poster1 (abstract number: Su1188), entitled
‘Randomized, double-blind, placebo-controlled, Phase 2 trial of
ondansetron 12 mg bimodal release tablets for diarrhea-predominant
irritable bowel syndrome (IBS-D)’, was selected as a poster of
distinction and for highlighting in an oral presentation at DDW
2018.
Data from the poster will be presented by Dr.
Terry F. Plasse, Medical Director at RedHill, as part of the IBS
ePoster tour on Monday, June 4, 2018, at 12:00 PM EDT, at the DDW
2018 ePosters Theater. ePosters tours, curated by society experts,
highlight the latest science featured in the Poster Hall in a small
theater setting. The poster will also be presented for general
viewing on Sunday, June 3, 2018, from 12:00 PM to 2:00 PM EDT in
Hall C, at Walter E. Washington Convention Center, Washington,
DC.
The abstract describes positive results of the
Phase II study with BEKINDA® (RHB-102)2 12 mg for IBS-D. The Phase
II study with BEKINDA® 12 mg successfully met its primary endpoint,
improving the primary efficacy outcome of stool consistency (per
FDA guidance definition) by an absolute difference of 20.7% vs.
placebo (p-value=0.036). Results from the BEKINDA® Phase II study
suggest that they compare favorably with previously reported
efficacy outcome values from studies with Xifaxan® (rifaximin) and
Viberzi® (eluxadoline) across all three efficacy endpoints3.
RedHill plans to meet with the FDA in the third quarter of 2018 to
discuss the design for possible pivotal Phase III studies with
BEKINDA® 12 mg for IBS-D.
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 and targets several gastrointestinal indications. A
first Phase III clinical study with BEKINDA® 24 mg for the
treatment of acute gastroenteritis and gastritis (the GUARD study)
successfully met its primary endpoint. A Phase II study with
BEKINDA® 12 mg for the treatment of diarrhea-predominant
irritable bowel syndrome (IBS-D) successfully met its primary
endpoint. The path to potential approval of BEKINDA® for the
intended indications of gastroenteritis and IBS-D is currently
under discussion with the FDA.
About Digestive Disease Week
2018:Digestive Disease Week® (DDW) is the largest
international gathering of physicians, researchers and academics in
the fields of gastroenterology, hepatology, endoscopy and
gastrointestinal surgery. Jointly sponsored by the American
Association for the Study of Liver Diseases (AASLD), the American
Gastroenterological Association (AGA) Institute, the American
Society for Gastrointestinal Endoscopy (ASGE) and the Society for
Surgery of the Alimentary Tract (SSAT), DDW takes place June 2-5,
2018, at Walter E. Washington Convention Center. The meeting
showcases more than 5,000 abstracts and hundreds of lectures on the
latest advances in GI research, medicine and technology. More
information can be found at www.ddw.org.
About RedHill Biopharma
Ltd.: RedHill Biopharma Ltd.
(NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) is a specialty
biopharmaceutical company, primarily focused on the development and
commercialization of late clinical-stage, proprietary drugs for the
treatment of gastrointestinal diseases. RedHill commercializes and
promotes three gastrointestinal products in the U.S.:
Donnatal® - a prescription oral
adjunctive drug used in the treatment of IBS and acute
enterocolitis; Esomeprazole Strontium
Delayed-Release Capsules 49.3 mg - a prescription
proton pump inhibitor indicated for adults for the treatment of
gastroesophageal reflux disease (GERD) and other gastrointestinal
conditions; and EnteraGam® - a
medical food intended for the dietary management, under medical
supervision, of chronic diarrhea and loose stools. RedHill’s key
clinical-stage development programs include: (i) TALICIA®
(RHB-105) for the treatment of
Helicobacter pylori infection with an ongoing confirmatory Phase
III study and positive results from a first Phase III study; (ii)
RHB-104, with an ongoing first Phase III study for
Crohn's disease; (iii) RHB-204, with a planned
pivotal Phase III study for nontuberculous mycobacteria (NTM)
infections; (iv) BEKINDA®
(RHB-102), with positive results from a Phase III
study for acute gastroenteritis and gastritis and positive results
from a Phase II study for IBS-D; (v) YELIVA®
(ABC294640), a first-in-class SK2 selective inhibitor,
targeting multiple oncology, inflammatory and gastrointestinal
indications, with an ongoing Phase IIa study for
cholangiocarcinoma; (vi) RHB-106, an encapsulated
bowel preparation licensed to Salix Pharmaceuticals, Ltd. and (vii)
RHB-107 (formerly MESUPRON), a Phase II-stage
first-in-class, serine protease inhibitor, targeting cancer and
inflammatory gastrointestinal diseases. 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 promote Donnatal® and Esomeprazole Strontium
Delayed-Release Capsules 49.3 mg and commercialize 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 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; (xii) estimates of the
Company’s expenses, future revenues, capital requirements and needs
for additional financing; (xiii) the effect of patients suffering
adverse experiences using investigative drugs under the Company's
Expanded Access Program; and (xiv) competition from other 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 22, 2018. All forward-looking statements
included in this press release are made only as of the date of this
press release. The Company assumes no obligation to update any
written or oral forward-looking statement, whether as a result of
new information, future events or otherwise, unless required by
law.
_____________________________
1 The abstract was authored by Terry Plasse, MD,
Danielle Abramson, PhD, Gilead Raday, MSc, Reza Fathi, PhD and Ira
Kalfus, MD from RedHill Biopharma; Gary Barton, MD from Arkansas
Gastroenterology; Evelyne Davidson, MD from New Phase Research
& Development and Louis Velez, MD from Applied Research Center
of Arkansas.2 BEKINDA® (RHB-102) is an investigational new drug,
not available for commercial distribution.3 For more details, see
RedHill’s press releases dated October 3, 2017 and January 16,
2018. Xifaxan® (rifaximin) prescribing information:
www.accessdata.fda.gov/drugsatfda_docs/label/2010/022554lbl.pdf;
Viberzi® (eluxadoline) prescribing information:
www.accessdata.fda.gov/drugsatfda_docs/label/2015/206940s000lbl.pdf;
Average absolute difference from reported Phase III studies; the
theoretical comparison between the BEKINDA® 12 mg Phase II study
results and reported data from studies of IBS-D-approved therapies
serves as a general benchmark for the effect size observed with
BEKINDA® 12 mg and should not be construed as a direct and/or equal
comparison given that the studies were not identical in design,
patient population and treatment period. For example, in the
Xifaxan® 550 mg Phase III studies, the referenced efficacy
endpoints were evaluated over a period of 4 weeks after 2 weeks
drug administration, and in the Viberzi® 100 mg Phase III studies
the referenced efficacy endpoints were evaluated after drug was
administered and evaluated for 12 weeks. The studies were not
conducted head-to head in the same patient
population.
Company contact:
Adi Frish
Senior VP Business Development & Licensing
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
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