RedHill Biopharma Announces Final Results from Phase II Study with BEKINDA® for IBS-D
January 16 2018 - 8:00AM
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 and cancer, today announced top-line final results1 from
the Phase II clinical study with BEKINDA® 12 mg (RHB-102)2 for the
treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).
- An independent review and analysis of the final results,
provided to the Company, confirmed that 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). The final top-line results improve upon the
previously announced top-line results (absolute difference of
19.4%, p-value=0.05).
- Results from the BEKINDA® Phase II study suggest that they
compare favorably with previously reported efficacy outcome values
from studies of Xifaxan® (rifaximin) and Viberzi® (eluxadoline)
across all three efficacy endpoints3.
- The randomized, double-blind, placebo-controlled Phase II study
evaluated the efficacy and safety of BEKINDA® 12 mg in 126
subjects over 18 years old in the U.S., who received either
BEKINDA® 12 mg or placebo, once daily, for a period of eight
weeks.
- IBS is one of the most common gastrointestinal disorders4,
affecting an estimated 30 million Americans, of which approximately
40% are estimated to be cases of IBS-D5; The U.S. market of IBS-D
therapies grew by approximately 550% between 2013-20166.
- RedHill plans to meet with the FDA in the first half of 2018 to
discuss the design for one or two 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. A 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) also successfully met its primary endpoint.
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 and cancer. RedHill 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) - an oral
combination therapy for the treatment of Helicobacter pylori
infection with an ongoing confirmatory Phase III study and
successful results from a first Phase III study ; (ii)
RHB-104 - an oral combination
therapy with an ongoing first Phase III study for Crohn's disease
and a planned pivotal Phase III study for nontuberculous
mycobacteria infections(NTM); (iii) YELIVA®
(ABC294640) - an orally-administered,
first-in-class SK2 selective inhibitor with an ongoing Phase IIa
study for cholangiocarcinoma; (iv) BEKINDA®
(RHB-102) - a once-daily oral
pill formulation of ondansetron with positive final results from a
Phase III study in acute gastroenteritis and gastritis and positive
top-line final results from a Phase II study in IBS-D; (v)
RHB-106 - an encapsulated bowel
preparation licensed to Salix Pharmaceuticals, Ltd. and (vi)
RHB-107 (MESUPRON) - a Phase
II-stage first-in-class, orally-administered protease inhibitor,
targeting pancreatic 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 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 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 23, 2017. 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.
|
|
Company
contact:Adi FrishSenior VP Business Development &
Licensing RedHill Biopharma+972-54-6543-112adi@redhillbio.com |
IR contact
(U.S.): Marcy NanusSenior Vice President The Trout
Group+1-646-378-2927Mnanus@troutgroup.com |
__________________
1 Final top-line results remain subject to the Clinical Study
Report (CSR).
2 BEKINDA® is an investigational new drug, not available for
commercial distribution.
3 For more details see RedHill’s press release
dated October 3, 2017. 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.
4 GlobalData PharmaPoint: Irritable Bowel
Syndrome – Global Drug Forecast and Market Analysis to 2023.
5 Lovell RM, Ford AC, Global prevalence of and
risk factors for irritable bowel syndrome: a meta-analysis, Clin
Gastroenterol Hepatol (2012), 10(7)712-721; Saito YA et al, The
epidemiology of irritable bowel syndrome in North America: a
systemic review, Am J Gastroenterol (2002), 97(8): 1910-5.
6 EvaluatePharma – USA sales by indication
(IBS-D) (July 2017).
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