DGAP-News: RedHill Biopharma Announces Successful PK Study with BEKINDA(TM) 12 mg and Submission to FDA of IBS-D Phase II Study Protocol


DGAP-News: RedHill Biopharma Ltd. / Key word(s): Study results
RedHill Biopharma Announces Successful PK Study with BEKINDA(TM) 12 mg and
Submission to FDA of IBS-D Phase II Study Protocol

11.02.2016 / 18:00
The issuer is solely responsible for the content of this announcement.

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Press Release

RedHill Biopharma Announces Successful PK Study with BEKINDA(TM) 12 mg and
Submission to FDA of IBS-D Phase II Study Protocol 
 
  - RedHill recently concluded a successful first-in-man pharmacokinetic
    (PK) study with BEKINDA(TM) 12 mg (RHB-102) proprietary formulation, to
    support the planned Phase II study for the treatment of
    diarrhea-predominant irritable bowel syndrome (IBS-D)

  - RedHill submitted to the FDA the protocol for the Phase II IBS-D study
    under the existing BEKINDA(TM) IND file and plans to initiate the study
    in the coming weeks

  - 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 the
    second half of 2016

TEL-AVIV, Israel, February 11, 2016 RedHill Biopharma Ltd. (NASDAQ/TASE:
RDHL) ("RedHill" or the "Company"), an Israeli biopharmaceutical company
primarily focused on the development and commercialization of late
clinical-stage, proprietary, orally-administered, small molecule drugs for
inflammatory and gastrointestinal diseases, including cancer, announced
today the successful completion of a first-in-man pharmacokinetic (PK)
study of BEKINDA(TM) 12 mg formulation, intended to be administered in the
Phase II study for the treatment of diarrhea-predominant irritable bowel
syndrome (IBS-D). RedHill further announced the submission to the U.S. Food
and Drug Administration (FDA) of the Investigational New Drug (IND)
protocol for the Phase II clinical study with BEKINDA(TM) 12 mg for IBS-D,
planned to be initiated in the coming weeks, subject to final preparations.

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

The randomized, double-blind, 2-arm parallel group Phase II clinical study
is designed to evaluate the safety and efficacy of BEKINDA(TM) 12 mg in
patients suffering from IBS-D. The study will be conducted in 12 clinical
sites in the U.S. and is expected to enroll 120 patients who 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, per FDA guidance definition.

RedHill recently concluded a first-in-man pharmacokinetic (PK) study with 
BEKINDA(TM) 12 mg proprietary formulation, intended to be administered in
the Phase II study for IBS-D. The PK study compared the PK profile of
BEKINDA(TM) 12 mg formulation with that of the previously studied
BEKINDA(TM) 24 mg to determine the relative bioavailability and
dose-linearity between the two. The PK study confirmed the results of
earlier RedHill studies demonstrating equivalent dose-adjusted
bioavailability and dose-linearity between the two strengths.

Gilead Raday, RedHill Senior VP Corporate and Product Development, said:
"We are very pleased about adding IBS-D to the indications targeted by
BEKINDA(TM) and believe that there is a clear need for better therapies for
IBS-D patients. The potential of BEKINDA(TM) 12 mg to provide an effective
and safe once-daily treatment is exciting, and is supported by clinical
research conducted with ondansetron. A successful outcome in the Phase II
study, planned to be initiated in the coming weeks, could potentially
position BEKINDA(TM) 12 mg as a preferred therapy in the IBS-D U.S. market
estimated to exceed $1 billion by 2020."


Irritable bowel syndrome (IBS) is a chronic multifactorial disorder
characterized by recurrent abdominal pain or discomfort associated with
altered bowel function. Diarrhea-predominant irritable bowel syndrome
(IBS-D) is the most common subtype of IBS in the U.S.  Certain factors that
may alter gastrointestinal function can contribute to IBS symptoms include
stress, prior gastroenteritis and changes in the gut microbiome. However,
the etiology of IBS is not well-understood and the underlying cause of IBS
in many cases remains unknown. IBS negatively impacts patients'
health-related 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 may suffer
from IBS , of which over 50% are cases of IBS-D . The U.S. potential market
for IBS-D treatments is estimated to exceed $1.25 billion by 2020.

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, has been approved for the
treatment of IBS in women with severe chronic IBS-D but is under a
restricted prescribing 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 patients
suffering from IBS-D.

About BEKINDA(TM) (RHB-102):
BEKINDA(TM) is a patent-protected, extended-release (24 hours) oral pill
formulation of the active ingredient ondansetron. RedHill is developing
BEKINDA(TM) for the treatment of acute gastroenteritis and gastritis as
well as for diarrhea-predominant irritable bowel syndrome (IBS-D) and for
the prevention of chemotherapy and radiotherapy-induced nausea and vomiting
(CINV and RINV, respectively). A Phase III clinical study with BEKINDA(TM)
for acute gastroenteritis and gastritis is ongoing in the U.S., with
top-line results expected in mid-late 2016. RedHill plans to initiate a
Phase II study with BEKINDA(TM) for the treatment of diarrhea-predominant
irritable bowel syndrome (IBS-D). RedHill is also pursuing marketing
approval of BEKINDA(TM) in Europe for the oncology support indications of
CINV and RINV prevention, 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 an emerging Israeli
biopharmaceutical company 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, including 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 top-line 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 a planned Phase II study for
IBS-D; (iv) RHB-106 - an encapsulated bowel preparation licensed to Salix
Pharmaceuticals, Ltd.; (v) YELIVA(TM) (ABC294640) - an orally-administered
first-in-class SK2 selective inhibitor targeting multiple oncology,
inflammatory and gastrointestinal indications with a Phase I/II study
initiated for refractory/relapsed diffuse large B-cell lymphoma (DLBCL);
(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 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; (vii) the implementation of the
Company's business model, strategic plans for its business and therapeutic
candidates; (viii) 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; (ix) parties from whom the Company
licenses its intellectual property defaulting in their obligations to the
Company; (x) estimates of the Company's expenses, future revenues capital
requirements and the Company's needs for additional financing; (xi)
competitive companies and technologies within the Company's industry; and
(xii) 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 26, 2015. 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.
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Company contact:                                      IR contact (U.S.):
Adi Frish                                             Marcy Nanus
Senior VP Business Development &                      Senior Vice President
                                                      The Trout Group
Licensing                                             +1-646-378-2927
RedHill Biopharma                                     Mnanus@troutgroup.com
+972-54-6543-112
adi@redhillbio.com


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11.02.2016 Dissemination of a Corporate News, transmitted by DGAP - a
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The issuer is solely responsible for the content of this announcement.

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436729 11.02.2016