DGAP-News: RedHill Biopharma Announces First Patients Dosed in Phase II Study with BEKINDA(TM) for IBS-D


DGAP-News: RedHill Biopharma Ltd. / Key word(s): Study
RedHill Biopharma Announces First Patients Dosed in Phase II Study with
BEKINDA(TM) for IBS-D

23.06.2016 / 14:13
The issuer is solely responsible for the content of this announcement.

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Press Release

RedHill Biopharma Announces First Patients Dosed in Phase II Study with
BEKINDA(TM) for IBS-D

  - The first patients have been dosed in the randomized, double-blind,
    placebo-controlled Phase II study with BEKINDA(TM) 12 mg for the
    treatment of diarrhea-predominant irritable bowel syndrome
    (IBS-D) in 120 subjects in 12 clinical sites in the U.S.

  - IBS is one of the most common gastrointestinal disorders, estimated to
    affect at least 30 million Americans of which over 50% suffer from IBS-
    D

  - A Phase III study with BEKINDA(TM) 24 mg for acute gastroenteritis and
    gastritis is ongoing in the U.S., with top-line results expected in
    late 2016

TEL-AVIV, Israel, June 23, 2016 RedHill Biopharma Ltd. (NASDAQ: RDHL)
(TASE: RDHL) ("RedHill" or the "Company"), a biopharmaceutical company
primarily focused on development and commercialization of late clinical-
stage, proprietary, orally-administered, small molecule drugs for
inflammatory and gastrointestinal diseases and cancer, today announced that
the first patients in the Phase II clinical study with BEKINDA(TM) 12 mg
for diarrhea-predominant irritable bowel syndrome (IBS-D) have been dosed.

The randomized, double-blind, placebo-controlled Phase II clinical study is
expected to enroll 120 subjects in 12 clinical sites in the U.S. and is
intended to evaluate the safety and efficacy of BEKINDA(TM) 12 mg in
patients with IBS-D.

BEKINDA(TM) is a proprietary, extended-release, once-daily oral pill
formulation of the antiemetic drug ondansetron, targeting multiple
gastrointestinal indications. RedHill is pursuing clinical studies with two
dose strengths of BEKINDA(TM), a 24 mg dose and a 12 mg dose, for two
different indications. A Phase III study of BEKINDA(TM) 24 mg for acute
gastroenteritis and gastritis is ongoing in the U.S. (the GUARD study),
with top-line results expected in late 2016.

Subjects enrolled in the Phase II study will be randomized 60:40 to receive
either BEKINDA(TM) 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 response in stool consistency as compared to
baseline, per FDA guidance definition. 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.

5-HT3 antagonists such as ondansetron, the active pharmaceutical ingredient
in BEKINDA(TM), have been shown to slow intestinal transit time in humans .
Alosetron (Lotronex(R)), a 5-HT3 antagonist of the same class of drugs as
ondansetron, has been approved 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 U.S. FDA as an
oncology support antiemetic, has demonstrated activity in IBS-D in
preliminary studies  and, in light of its good safety profile, RedHill
believes that BEKINDA(TM), if approved, has the potential to be a preferred
once-daily treatment for a broad segment of patients suffering from IBS-D.

IBS is a chronic multifactorial disorder characterized by recurrent
abdominal pain or discomfort associated with altered bowel function.
Diarrhea-predominant irritable bowel syndrome is the most common subtype of
IBS in the U.S.  Certain factors that may alter gastrointestinal function
can contribute to IBS symptoms, including stress, prior gastroenteritis and
changes in the gut microbiome. However, the etiology of IBS is not
understood and the underlying cause of IBS remains unknown. IBS negatively
impacts patients' quality of life and can affect patients physically,
emotionally, socially and economically.

IBS is one of the most common GI disorders; it is estimated that at least
30 million Americans suffer from IBS , of which over 50% are cases of IBS-
D4. The U.S. potential market for IBS-D treatments is estimated to exceed
$1.3 billion by 2020 .

About BEKINDA(TM) (RHB-102):
BEKINDA(TM) 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 of BEKINDA(TM) 24 mg formulation for acute
gastroenteritis and gastritis (the GUARD study) is ongoing in the U.S.,
with top-line results expected in late 2016. A Phase II study with
BEKINDA(TM) 12 mg formulation is ongoing in the U.S. for the treatment of
diarrhea-predominant irritable bowel syndrome (IBS-D). RedHill is also
pursuing marketing approval of BEKINDA(TM) in Europe for the prevention of
chemotherapy and radiotherapy-induced nausea and vomiting (CINV and RINV,
respectively), pending additional feedback from EU member states as to
whether additional clinical and CMC work is required.

About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) is a 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 inflammatory and gastrointestinal
diseases and cancer. RedHill's current pipeline of proprietary products
includes: (i) RHB-105 - an oral combination therapy for the treatment of
Helicobacter pylori infection with successful results from a first Phase
III study; (ii) RHB-104 - an oral combination therapy for the treatment of
Crohn's disease with an ongoing first Phase III study and an ongoing proof-
of-concept Phase IIa study for multiple sclerosis; (iii) BEKINDA(TM)
(RHB-102) - a once-daily oral pill formulation of ondansetron with an
ongoing Phase III study in the U.S. 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(TM)
(ABC294640) - a Phase II-stage, orally-administered, first-in-class SK2
selective inhibitor targeting multiple oncology, inflammatory and
gastrointestinal indications; (vi) MESUPRON(R) - a Phase II-stage first-in-
class uPA inhibitor, administered by oral capsule, targeting
gastrointestinal and other solid tumors; (vii) RP101 - currently subject to
an option-to-acquire by RedHill, RP101 is a Phase II-stage first-in-class
Hsp27 inhibitor, administered by oral tablet, targeting pancreatic and
other gastrointestinal cancers; (viii) RIZAPORT(TM) (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 Germany in October 2015; and (ix) RHB-101 - a once-daily oral
pill formulation of the cardio drug carvedilol.

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 establish
and maintain corporate collaborations; (vi) 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;
(vii) 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;
(viii) the implementation of the Company's business model, strategic plans
for its business and therapeutic candidates; (ix) 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; (x)
parties from whom the Company licenses its intellectual property defaulting
in their obligations to the Company; (xi) estimates of the Company's
expenses, future revenues capital requirements and the Company's needs for
additional financing; (xii) competitive companies and technologies within
the Company's industry; and (xiii) the impact of the political and security
situation in Israel on the Company's business. 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 25, 2016. 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.
<pre>

Company contact:                                      IR contact (U.S.):
Adi Frish                                             Marcy Nanus
Senior VP Business Development &                      Senior Vice President
Licensing                                             The Trout Group
RedHill Biopharma                                     +1-646-378-2927
+972-54-6543-112                                      Mnanus@troutgroup.com
adi@redhillbio.com


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23.06.2016 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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473865 23.06.2016