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2016-12-13

RedHill Biopharma Announces Positive and Unanimous DSMB Recommendation for Continuation of Phase III Study with RHB-104 for Crohn’s Disease

RedHill Biopharma Ltd.
Press release

RedHill Biopharma Announces Positive and Unanimous DSMB Recommendation for
Continuation of Phase III Study with RHB-104 for Crohn’s Disease

-- Following a pre-planned review of safety data, RedHill has received a
unanimous recommendation from the independent Data and Safety Monitoring
Board (DSMB) to continue the MAP US Phase III study with RHB-104 for
Crohn’s disease as planned, without any modifications
-- A second DSMB meeting, expected in Q2/2017, will include an interim
efficacy analysis and will evaluate the option of an early stop for success
for overwhelming efficacy, according to a pre-specified statistical
significance threshold

TEL-AVIV, Israel, Dec. 13, 2016 (GLOBE NEWSWIRE) -- 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
gastrointestinal and inflammatory diseases and cancer, today reported that,
following a pre-planned review of safety data from its ongoing Phase III study
with RHB-104 for Crohn’s disease (the MAP US study) by an independent Data and
Safety Monitoring Board (DSMB), it has received a unanimous recommendation to
continue the study as planned, without any modifications.

RHB-104 is a proprietary and potentially groundbreaking antibiotic combination
therapy in oral capsule formulation, with potent intracellular,
anti-mycobacterial and anti-inflammatory properties. The development of RHB-104
is based on increasing evidence supporting the hypothesis that Crohn’s disease,
and potentially other autoimmune diseases, are related to Mycobacterium avium
subspecies paratuberculosis (MAP) infection in susceptible patients. The
development of RHB-104 is consistent with the growing awareness of the
possibility that a bacterially-induced dysregulated immune system may
contribute to the pathogenesis of various autoimmune diseases of unknown
etiology.

The ongoing MAP US study is a randomized, double-blind, placebo-controlled
first Phase III study intended to evaluate the safety and efficacy of RHB-104
in patients with moderately to severely-active Crohn’s disease (defined as
Crohn’s Disease Activity Index (CDAI) between 220 and 450). To date, 242
patients have been enrolled out of a planned total of 410 patients in up to 150
clinical sites in the U.S, Canada, Europe, Israel, Australia and New Zealand.

Subjects enrolled in the MAP US study are randomized 1:1 to receive RHB-104 or
a placebo, with a primary endpoint of disease remission, defined as reduction
in CDAI to less than 150 at week 26. Secondary and exploratory endpoints
include, among others, state of response at week 26, maintenance of remission
through week 52, endoscopic evaluation of mucosal healing and efficacy outcome
measures in relation to the presence of MAP bacterial infection. Additional
studies will be required to support a U.S. New Drug Application (NDA) for
RHB-104.

Two additional independent DSMB meetings are expected to take place in the MAP
US study after 50% and after 75% of the 410 patients planned to be enrolled in
the study will complete 26 weeks of study participation. The second independent
DSMB meeting is expected in the second quarter of 2017 after the first 205
patients are expected to complete 26 weeks of study participation (patient 205
was randomized in August 2016).

The second DSMB meeting will include safety and interim efficacy analysis and
could potentially provide the opportunity to expedite the data locking process
for the final analysis, once the study is complete. Importantly, this
independent DSMB meeting will evaluate the option of an early stop for success
for overwhelming efficacy, according to a pre-specified statistical
significance threshold for analysis of RHB-104 versus placebo in the primary
endpoint. If the pre-specified threshold is met at the second DSMB meeting, the
study could be stopped for efficacy or inefficacy. If the pre-specified
threshold is not met during the interim analysis, the MAP US study is planned
to continue through randomization of all 410 patients and follow-up at week 26.

Taking into account the increase in the total number of patients planned in the
MAP US study, and assuming the study is not stopped for success or inefficacy
following the DSMB meeting in the second quarter of 2017, completion of
recruitment is expected by the end of 2017.

RedHill is advancing its preparation to initiate an open-label extension study
for all patients who have completed 26 weeks of treatment in the MAP US study
and failed to achieve remission at week 26, the study’s primary endpoint.
Patients with a Crohn’s Disease Active Index (CDAI) score of greater than 150
at week 26 will be offered the opportunity to receive treatment with active
drug (RHB-104) for a 52-week period. This study is considered separate from the
MAP US study and data collected will be supplemental to the MAP US study data.

About RHB-104:
Currently in a first Phase III study for the treatment of Crohn’s disease (the
MAP US study), RHB-104 is a proprietary and potentially groundbreaking oral
antibiotic combination therapy, with potent intracellular, anti-mycobacterial
and anti-inflammatory properties. RHB-104 is based on increasing evidence
supporting the hypothesis that Crohn’s disease is caused by Mycobacterium avium
subspecies paratuberculosis (MAP) infection in susceptible patients. Clinical
trials conducted with earlier formulations of RHB-104 include an Australian
Phase III study conducted by Pharmacia/Pfizer. RedHill has conducted several
supportive studies with the current formulation of RHB-104 and a long-term
population pharmacokinetic (pop-PK) study is ongoing as part of the Phase III
MAP US study. RHB-104 is covered by several issued and pending patents. RedHill
has also completed a Phase IIa, proof-of-concept clinical study, evaluating
RHB-104 as an add-on therapy to interferon beta-1a in patients treated for
relapsing-remitting multiple sclerosis (the CEASE MS study). Top-line final
results from the CEASE MS study suggest meaningful positive safety and clinical
signals upon 24 weeks treatment with RHB-104 as an add-on therapy, thereby
supporting further clinical development.

About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (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 gastrointestinal and inflammatory
diseases and cancer. RedHill’s 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 a completed proof-of-concept Phase IIa study
for multiple sclerosis; (iii) BEKINDA® (RHB-102) -a once-daily oral pill
formulation of ondansetron with an ongoing 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® (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 uPA inhibitor, targeting gastrointestinal
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 Germany in
October 2015.

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-l...

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