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DGAP-News: RedHill Biopharma Ltd. / Key word(s): Study
RedHill Biopharma Announces Last Patient Visit in BEKINDA(R) Phase II Study
2017-07-17 / 15:56
The issuer is solely responsible for the content of this announcement.
*RedHill Biopharma Announces Last Patient Visit in BEKINDA(R) Phase II Study
? *Top-line results are expected in September 2017 *
? *The randomized, double-blind, placebo-controlled Phase II study is
evaluating the safety and efficacy of BEKINDA(R) (RHB-102) 12 mg in 127
U.S. patients with diarrhea-predominant irritable bowel syndrome (IBS-D),*
*with a primary endpoint of response in stool consistency as compared to
? *IBS is one of the most common gastrointestinal disorders, with up to 30
million American sufferers, of which over 50% are cases of IBS-D; The U.S.
market for IBS-D therapies grew by approximately 550% between 2013-2016,
to an estimated $473 million in 2016, and is expected to continue to grow
by approximately 14% annually (2016 - 2022)*
? *If approved, BEKINDA(R) 12 mg has the potential to be a preferred
once-daily treatment for a broad segment of patients suffering from IBS-D*
? *Positive top-line results from the Phase III GUARD study with
BEKINDA(R) 24 mg for acute gastroenteritis and gastritis indicated that
the study successfully met its primary endpoint, and BEKINDA(R) 24 mg was
shown to be effective, safe and well tolerated in patients with acute
gastroenteritis and gastritis *
*TEL-AVIV, Israel / RALEIGH, NC, July 17, 2017* 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 last patient
enrolled in the Phase II study with BEKINDA(R) (RHB-102) 12 mg for the
treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) has
completed the treatment course and follow-up visit. Top-line results are
expected in September 2017.
BEKINDA(R) is a proprietary, bimodal extended-release, once-daily, oral pill
formulation of the antiemetic drug ondansetron, targeting several
The randomized, double-blind, placebo-controlled Phase II study is
evaluating the efficacy and safety of BEKINDA(R) 12 mg in adults, 18 years
and older, who suffer from IBS-D. The study enrolled 127 subjects at 16
clinical sites in the U.S.
Subjects enrolled in the study were randomized 60:40 to receive either
BEKINDA(R) 12 mg or a placebo, once daily, for a period of eight weeks. The
primary endpoint for the study is the proportion of patients in each
treatment group with stool consistency response as compared to baseline, per
FDA guidance definition (a decrease of >=50% in the number of days per week
with at least one stool that has a consistency of 6 or 7 per the Bristol
stool scale and no increase in abdominal pain over the week). Secondary
endpoints include the proportion of patients in each treatment group who are
pain responders and the proportion of patients in each treatment group who
are responders to the combined endpoints of stool consistency and pain, per
FDA guidance definition.
IBS is one of the most common gastrointestinal disorders. It is estimated
that up to 30 million Americans suffer from IBS, of which over 50% are
cases of IBS-D. The U.S. market for IBS-Dtherapies grew by approximately
550% between 2013-2016, to an estimated $473 million in 2016, and is
expected to continue to grow with a compound annual growth rate (CAGR) of
14% (2016 - 2022).
5-HT3 antagonists such as ondansetron, the active pharmaceutical ingredient
in BEKINDA(R), have been shown to slow intestinal transit time in humans.
Alosetron (Lotronex(R)), a different 5-HT3 antagonist of the same class of
drugs as ondansetron, has been approved by the FDA for the treatment of
women with severe chronic IBS-D, but is under a restricted prescribing
(REMS) program due to potential severe side effects. Ondansetron,
approved by the FDA as an oncology support antiemetic, has demonstrated
activity in IBS-D in preliminary studies and, in light of its safety
profile, RedHill believes that BEKINDA(R), if approved, has the potential to
be a preferred once-daily treatment for a broad segment of patients
suffering from IBS-D.
In addition to the BEKINDA(R) 12 mg Phase II IBS-D program, RedHill recently
announced positive top-line results from the Phase III GUARD study with
BEKINDA(R) 24 mg, a different formulation of BEKINDA(R). The Phase III GUARD
study successfully met its primary endpoint of efficacy in the treatment of
acute gastroenteritis and gastritis, and BEKINDA(R) 24 mg was found to be
safe and well tolerated in this indication.
The Phase II study and the Phase III GUARD study with BEKINDA(R) are
registered on www.ClinicalTrials.gov , a web-based service of the U.S.
National Institutes of Health, which provides access to information on
publicly and privately supported clinical studies.
*About BEKINDA*(R) *(RHB-102):*
BEKINDA(R) is a proprietary, bimodal extended-release (24 hours) oral pill
formulation of ondansetron, covered by several issued and pending patents.
Positive top-line results from a Phase III clinical study of BEKINDA(R) 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(R) 12 mg is
ongoing in the U.S. for the treatment of diarrhea-predominant irritable
bowel syndrome (IBS-D), with patient treatment 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(R)*, a prescription oral
adjunctive drug used in the treatment of IBS and acute enterocolitis, and
*EnteraGam(R)*, 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(TM) (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(R)
(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(R) (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(R) (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:
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(R)and
EnteraGam(R), (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
(MORE TO FOLLOW) Dow Jones Newswires
July 17, 2017 09:56 ET (13:56 GMT)
PRESS RELEASE: RedHill Biopharma Announces Last Patient Visit in BEKINDA(R) Phase II Study for IBS-D| Quelle: Dow Jones Newswire Web
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