RedHill Biopharma Announces Positive Top-Line Results from Phase II Study of BEKINDA® in Patients with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

(Thomson Reuters ONE) -


* BEKINDA®i 12 mg Phase II study successfully met its primary endpoint,
improving primary efficacy outcome of stool consistency by an absolute
difference of 19.4% vs. placebo and comparing favorably with previously
reported outcomes from studies of Xifaxan® (rifaximin) and
Viberzi® (eluxadoline)ii
* IBS is one of the most common gastrointestinal disorders, affecting an
estimated 30 million Americans, of which over 50% are cases of IBS-D; The
U.S. market of IBS-D therapies grew by approximately 550% between 2013-2016
* RedHill intends to pursue Phase III studies with BEKINDA® 12 mg and plans to
meet with the FDA by early 2018 to discuss the path towards potential U.S.
marketing approval
* Top-line results remain subject to completion of the independent review and
analysis of the Clinical Study Report (CSR)
* In addition, following a successful first Phase III study and a positive
guidance meeting with the FDA, RedHill is designing a confirmatory Phase III
study to support a New Drug Application (NDA) for BEKINDA® 24 mg for acute
gastroenteritis and gastritis
* RedHill will host a conference call and webcast today, Tuesday, October
3, 2017, at 9:00 am EDT, to discuss the top-line results from the
BEKINDA® 12 mg Phase II study, dial-in details can be found below and on the
Company's website: http://ir.redhillbio.com/events.cfm

TEL-AVIV, Israel and RALEIGH, N.C., Oct. 03, 2017 (GLOBE NEWSWIRE) -- 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 positive top-line results from the Phase II

clinical study of BEKINDA® (RHB-102) 12 mg for the treatment of diarrhea-
predominant irritable bowel syndrome (IBS-D).

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 at 16
clinical sites in the U.S. Subjects were randomized 60:40 to receive either
BEKINDA® 12 mg or placebo, once daily, for a period of eight weeks.

BEKINDA® 12 mg Phase II study successfully met its primary endpoint, improving
the primary efficacy outcome of stool consistency response (per FDA guidance
definition) by an absolute difference of 19.4%, with 54.7% responders of
subjects treated with BEKINDA® (n=75) vs. 35.3% responders of the placebo
subjects (n=51) (p = 0.05). These top-line results compare favorably with
previously reported efficacy outcome values for stool consistency response from
two Phase III studies of Xifaxan® (rifaximin) 550 mg (averaged absolute
difference from Trial 1 and Trial 2 of 10.5%) and two Phase III studies of
Viberzi® 100 mg (eluxadoline) (averaged absolute difference of 13.5%)ii.

BEKINDA® 12 mg was also shown to be safe and well tolerated. No serious adverse
events, new or unexpected safety issues were noted in the study, suggesting the
potential of BEKINDA® 12 mg, if approved, to become a first-line standard of
care treatment for IBS-D.

Terry F. Plasse, MD, RedHill's Medical Director, said: "We are greatly
encouraged by the top-line results from the Phase II study which demonstrated
that BEKINDA® 12 mg could be an effective treatment for patients suffering from
IBS-D, and we look forward to discussing the path towards potential marketing
approval in the U.S. with the FDA. Despite recent new drug approvals for IBS-D,
there is still a clear unmet medical need for safe and effective new therapies
in this indication. I would like to thank the patients and physicians who took
part in our study. We will continue to work diligently to bring BEKINDA® 12 mg
to the market as quickly as possible."

June S. Almenoff, MD, PhD, a member of RedHill's Advisory Board and former
President and Chief Medical Officer of Furiex Pharmaceuticals, added: "BEKINDA®
12 mg demonstrated a very good safety profile in this study as well as
impressive efficacy. If both the safety and efficacy results are reproduced in
the planned pivotal studies, possibly powered to win on pain as well, BEKINDA®
12 mg has the potential, if approved, to become an important new therapy and
standard-of-care for IBS-D."

While not powered for statistical significance of the secondary efficacy
endpoints, the study suggested clinically meaningful improvement in both
secondary efficacy endpoints of abdominal pain response and overall response
(combined stool consistency and abdominal pain response). The secondary efficacy
endpoints results also compared favorably to the absolute difference observed
for these endpoints in reported studies of Xifaxan® and Viberzi®ii: Top-line
results from the Phase II study demonstrated that BEKINDA® 12 mg improved the
overall worst abdominal pain response rate by 11.5% vs. placebo (50.7% with
BEKINDA® 12 mg (n=75) vs. 39.2% with placebo (n=51); (p=0.28)), which compares
favorably with previously reported efficacy outcome values for abdominal pain
response from two Phase III studies of Xifaxan® 550 mg (averaged absolute
difference from Trial 1 and Trial 2 of 9.0%) and from two Phase III studies of
Viberzi® 100 mg (averaged absolute difference of 5.0%)ii. Furthermore, the
overall response rate (composite measure of stool consistency and abdominal pain
response) in the BEKINDA® 12 mg Phase II study demonstrated an absolute
difference of 15.8% in favor of the BEKINDA® 12 mg arm (41.3% with BEKINDA® 12
mg (n=75) vs. 25.5% with placebo (n=51); (p=0.10)), also comparing favorably
with previously reported efficacy outcome values for overall response from two
Phase III studies of Xifaxan®550 mg (averaged absolute difference from Trial 1
and Trial 2 of 9.5%) and from two Phase III studies of Viberzi® 100 mg (averaged
absolute difference of 10.5%)ii.

The theoretical comparison between the BEKINDA® 12 mg Phase II study results and
published data from studies of IBS-D-approved therapies Xifaxan® and Viberzi®
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 duration
and were not conducted head-to head in the same patient populationii.

RedHill will continue to analyze the data from the Phase II study with
BEKINDA® 12 mg, including all secondary endpoints. RedHill is also analyzing
drug allocation and pharmacokinetics in the study, including some aberrant
findings which are not expected to have a material impact on the final results.
The top-line results were provided to RedHill by an independent third party
following an independent analysis and remain subject to completion of the
independent review and analysis of the underlying data, including all safety,
secondary and other outcome measures, and completion of the Clinical Study
Report (CSR), expected in the first quarter of 2018. Detailed results from the
Phase II study will be submitted for presentation at upcoming scientific
conferences.

IBS is one of the most common gastrointestinal disordersiii. It is estimated
that up to 30 million Americans suffer from IBSiv, of which over 50% are cases
of IBS-Dv. 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 with a compound annual growth rate (CAGR) of 14% (2016 -
2022)vi.

BEKINDA® is a proprietary, bimodal extended-release, once-daily, oral pill
formulation of the antiemetic drug ondansetron, targeting several
gastrointestinal indications. 5-HT3 antagonists such as ondansetron, the active
pharmaceutical ingredient in BEKINDA®, have been shown to slow intestinal
transit time in humansvii. Alosetron (Lotronex®), 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 effectsviii. Other
products, including Xifaxanâ  and Viberziâ, have been approved for IBS-D, but
many patients do not benefit from these treatments. RedHill believes that
BEKINDA® 12 mg, 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® 12 mg Phase II IBS-D program, RedHill announced in
June 2017 positive top-line results from the Phase III GUARD study with
BEKINDA® 24 mg. The Phase III GUARD study successfully met its primary endpoint
of efficacy in the treatment of acute gastroenteritis and gastritis, and
BEKINDA® 24 mg was found to be safe and well tolerated in this indication.
RedHill recently met with the FDA to discuss the results of the Phase III GUARD
study and the clinical and regulatory path towards potential marketing approval
of BEKINDA® 24 mg in the U.S. Following the positive guidance meeting, the
Company is currently working with the FDA to design the confirmatory Phase III
study to support a New Drug Application (NDA) with BEKINDA® 24 mg for acute
gastroenteritis and gastritis.

The Company will host a conference call and webcast today, October 3, 2017, at
9:00 a.m. EDT to discuss the top-line results from the BEKINDA® Phase II study
for IBS-D.

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:
+1-877-280-2342; International: +1-646-254-3365; and Israel: +972-3-763-0146.
The access code for the call is 7238671.

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.
Positive 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. Positive top-line results from a Phase II study with
BEKINDA® 12 mg for the treatment of diarrhea-predominant irritable bowel
syndrome (IBS-D) were announced in October 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 three gastrointestinal
products in the U.S. - Donnatal®, a prescription oral adjunctive drug used in
the treatment of IBS and acute enterocolitis, EnteraGam®, a medical food
intended for the dietary management, under medical supervision, of chronic
diarrhea and loose stools, and 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. 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 a planned
pivotal Phase III study for nontuberculous mycobacteria (NTM) infections;
(iii) BEKINDA® (RHB-102) - a once-daily oral pill formulation of ondansetron
with successful top-line results from a Phase III study in acute gastroenteritis
and gastritis and from a Phase II study in 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 and projected cost savings from
any changes to these trials; (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) the Company's Expanded Access Program, which
allows patients with life-threatening diseases potential access, subject to
regulatory and other approvals, to RedHill's investigational new drugs that have
not yet received regulatory marketing approval, if a patient suffers an adverse
experience using such investigative drug, potentially adversely affecting the
clinical development program of that investigational product or the Company
generally; (xiv) 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(at)redhillbio.com

IR contact (U.S.):
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus(at)troutgroup.com

i BEKINDA® is an investigational new drug, not available for commercial
distribution.

ii 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® 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® 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® Phase III studies,
the referenced efficacy endpoints were evaluated over a period of 4 weeks after
2 weeks drug administration, and in the Viberzi® 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.

iii GlobalData PharmaPoint: Irritable Bowel Syndrome - Global Drug Forecast and
Market Analysis to 2023.

iv 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.

v GlobalData PharmaPoint: Irritable Bowel Syndrome - Global Drug Forecast and
Market Analysis to 2023.

vi EvaluatePharma - USA sales by indication (IBS-D) (July 2017).

vii Garsed K. et al, A randomised trial of ondansetron for the treatment of
irritable bowel syndrome with diarrhea, Gut (2014), 63(10): 1617-25.

viii www.fda.gov, post market drug safety information for patients and
providers.




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: RedHill Biopharma Ltd. via GlobeNewswire

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Datum: 03.10.2017 - 13:40 Uhr
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