RedHill Biopharma Provides 2016 Semi-Annual R&D Update

(Thomson Reuters ONE) -


TEL-AVIV, Israel, Aug. 11, 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 provided an update
on select research and development potential milestones and estimated timelines.

"RedHill continues to pursue its multiple-shots-on-goal strategy with a focus on
advancing its three ongoing gastroenterology Phase III programs in the U.S.,
RHB-105 for H. pyloriinfection, RHB-104 for Crohn's disease and BEKINDA(®) for
gastroenteritis, as well as additional Phase II programs, supported by a strong
and debt-free balance sheet," stated Mr. Dror Ben-Asher, RedHill's Chief
Executive Officer. "We continue to further enhance the overall robustness of our
flagship Phase III programs and increase data collection in support of future
potential new drug applications, while maintaining a substantially consistent
cash burn through the end of 2017." Mr. Ben-Asher added, "In light of strong
recruitment rates in the ongoing Phase II study with BEKINDA(®) for IBS-D, we
are pleased to provide guidance, for the first time, on the estimated timing for
top-line results, which are anticipated in mid-2017. RedHill is well-positioned
for continued solid growth and we look forward to several Phase III and Phase II
data points and other important milestones and potential catalysts expected in
the coming months."

RHB-105 - H. pylori bacterial infection (confirmatory Phase III)

* Following the positive FDA meeting in April 2016, and in light of guidance
received on the potential path for marketing approval, preparations continue
for the confirmatory Phase III study with RHB-105 for the treatment of H.

pylori infection. The two-arm, randomized, double-blind, active comparator
confirmatory Phase III study is planned to be initiated in the fourth
quarter of 2016 or in the first quarter of 2017, following completion of a
supportive pharmacokinetic (PK) program. The study is planned to enroll
approximately 440 patients in up to 50 clinical sites in the U.S.

The planned confirmatory Phase III study, along with the results from the
successfully completed first Phase III study (the ERADICATE Hp study) and
data to be obtained from a supportive PK program, are expected to support a
U.S. New Drug Application (NDA) for RHB-105. The first Phase III clinical
study with RHB-105 successfully met its primary endpoint of superiority over
historical standard-of-care (SoC) eradication rate of 70%, with high
statistical significance (p<0.001). The Phase III ERADICATE Hp study results
demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-
105. Notably, subsequent open-label treatment with SoC therapies of patients
in the placebo arm of the Phase III ERADICATE Hp study demonstrated only
63% eradication rate, further supporting the potential superior efficacy of
RHB-105 over SoC.

RHB-104 - Crohn's disease (Phase III) and multiple sclerosis (Phase IIa)

Crohn's disease - first Phase III study ongoing

* Approximately 200 subjects out of the planned total of 270 have been
enrolled to date in the randomized, double-blind, placebo-controlled first
Phase III study with RHB-104 for Crohn's disease (the MAP US study).

Interim data and safety monitoring board (DSMB) analysis is on track to take
place in the fourth quarter of 2016 and RedHill remains blinded to the
interim and ongoing results.

RedHill is currently reviewing a possible amendment to the Phase III MAP US
study protocol intended to further enhance the overall robustness of the
study, provide a more precise assessment of RHB-104's treatment effect,
collect additional endoscopic mucosal healing data, further evaluate the
Crohn's disease population enrolled and address retention and early
terminations. No changes are planned to the primary endpoint of remission at
week 26 or the study's 90% power. Taking into account a potential protocol
amendment, completion of recruitment is expected in 2017 with no anticipated
material impact on the Company's overall cash burn rate through the end of
2017. The Company expects to provide further details in the coming weeks,
once plans are finalized.

Multiple sclerosis - Phase IIa study ongoing

* Top-line final results from the Phase IIa CEASE-MS study with RHB-104 for
relapsing-remitting multiple sclerosis (RRMS) are expected in the fourth
quarter of 2016, following the recently announced last patient follow-up
visit in the study. In the first 24 weeks, patients enrolled in the CEASE-MS
study received treatment with RHB-104 as an add-on therapy to interferon
beta-1a and were then evaluated for an additional 24-week follow-up period
during which they were treated with interferon beta-1a alone. Top-line
interim results announced in March 2016, after completion of the 24-week
treatment period, demonstrated positive safety and efficacy signals,
including an encouraging relapse-free rate, Expanded Disability Status Scale
(EDSS) scores and MRI results, which support further clinical development.

BEKINDA(® )(RHB-102) - acute gastroenteritis (Phase III) and IBS-D (Phase II)

Acute gastroenteritis and gastritis - Phase III study ongoing

* RedHill has implemented a protocol amendment to the ongoing Phase III study
with BEKINDA(® )24 mg for acute gastroenteritis (the GUARD study) to
increase the safety data collected, so that the study results may support a
potential NDA filing, as per FDA's recommendation. The study protocol now
requires patients to remain in the emergency room for a longer follow-up
period and perform an ECG (electrocardiogram) at the end of follow-up and
prior to discharge. In light of this amendment, completion of patient
enrollment in the randomized, double-blind, placebo-controlled Phase III
GUARD study is currently expected in early 2017.

IBS-D - Phase II study ongoing

* Completion of patient enrollment in the ongoing randomized, double-blind,
placebo-controlled Phase II study with BEKINDA(®) 12 mg for the treatment of
diarrhea-predominant irritable bowel syndrome (IBS-D) is expected in the
first half of 2017, with top-line results expected mid-2017.

YELIVA((TM) )- Phase I/II studies for multiple oncology and inflammatory
indications

* A Phase I/II study with YELIVA((TM)), a first-in-class SK2 selective
inhibitor, for the treatment of refractory or relapsed multiple myeloma is
planned to be initiated later this year at Duke University Medical Center.
The study is supported by a $2 million grant from the National Cancer
Institute (NCI) awarded to Apogee Biotechnology Corp. (Apogee) in
conjunction with Duke University, with additional support from RedHill.

* A Phase II study with YELIVA((TM)) for the treatment of advanced
hepatocellular carcinoma is planned to be initiated later this year. The
study will be conducted at the Medical University of South Carolina (MUSC)
Hollings Cancer Center and additional clinical centers in the U.S. It is
supported by a $1.8 million grant from the NCI awarded to MUSC, intended to
fund a broad range of studies on the feasibility of targeting sphingolipid
metabolism for the treatment of a variety of solid tumor cancers, including
the Phase II study with YELIVA((TM)), and will be further supported by
additional funding from RedHill.

* A Phase I/II clinical study to evaluate YELIVA((TM)) as a radioprotectant to
prevent mucositis in cancer patients undergoing therapeutic radiotherapy is
planned to be initiated later this year.

* A Phase I/II clinical study evaluating YELIVA((TM)) in patients with
refractory/relapsed diffuse large B-cell lymphoma (DLBCL) was initiated at
the Louisiana State University Health Sciences Center (LSUHSC) in New
Orleans in June 2015 and was recently put on administrative hold, pending a
protocol amendment aimed at improving overall recruitment prospects. The
study is supported by a grant awarded to Apogee from the NCI, as well as
additional support from RedHill.

* Following the successful Phase I study with YELIVA((TM) )in patients with
advanced solid tumors, and in light of the drug's novel mechanism of action,
RedHill is evaluating potential clinical studies for additional oncology and
inflammatory indications, as well as potential collaboration opportunities
to evaluate YELIVA((TM)) as an add-on therapy.

RHB-106 - encapsulated bowel preparation, exclusive worldwide rights licensed to
Salix Pharmaceuticals (now Valeant Pharmaceuticals International)

* The exclusive worldwide rights to RedHill's RHB-106 encapsulated bowel
cleanser, as well as additional related rights (RHB-106 Program), were
licensed to Salix Pharmaceuticals Ltd. in 2014, which was acquired by
Valeant Pharmaceuticals International Inc. (Valeant) in 2015. Valeant
remains fully responsible for the development of the RHB-106 Program and for
future potential commercialization. RedHill has recently been informed by
Valeant that, as a result of Valeant's greater focus on R&D investment, the
development of the RHB-106 Program continues to be explored.

* Earlier this week, Valeant highlighted their commitment to bolstering their
R&D and commercial offering and enhance their gastrointestinal business with
the acquisition of the North American rights to a powder for oral solution
bowel cleanser (NER1006) from Norgine B.V.

Ebola virus disease therapy (RedHill's proprietary experimental therapy) - NIH
collaboration

* Initiation of the research collaboration with the U.S. National Institute of
Allergy and Infectious Diseases (NIAID), part of the National Institutes of
Health (NIH), is expected in the fourth quarter of 2016. The new study is
intended to evaluate RedHill's proprietary experimental therapy for the
treatment of Ebola virus disease and follows encouraging results from
preliminary non-clinical studies conducted in conjunction with NIAID. Top-
line results from the study are expected in 2017.


RIZAPORT(®) (RHB-103) - acute migraines (approved for marketing in Germany)

* Re-submission of the RIZAPORT(®) U.S. NDA to the FDA is expected in the
first half of 2017. RIZAPORT(®) was approved for marketing in Germany under
the European Decentralized Procedure (DCP) in October 2015 and a first
commercialization agreement was recently signed with Grupo JUSTE S.A.Q.F for
Spain and additional potential territories.

RedHill continues discussions with additional potential commercialization
partners for RIZAPORT(®) in the U.S., Europe and other territories.

MESUPRON - First-in-class small molecule for oncology indications (Phase II-
stage)

* RedHill's current development program for MESUPRON includes nonclinical
studies as well as re-analysis of certain prior clinical data. MESUPRON is a
first-in-class, orally-administered uPA inhibitor targeting gastrointestinal
and other solid tumors. MESUPRON completed a total of ten Phase I and Phase
II clinical studies, and the ongoing development program is intended to
better define the molecular markers and patient population for future
clinical studies. RedHill plans to initiate a Phase II development program
with MESUPRON in 2017, subject to a successful outcome in the ongoing
nonclinical studies.

RP101 - First-in-class small molecule for oncology indications (Phase II-stage)

* RedHill has extended the term of the August 2014 exclusive option agreement
with RESprotect GmbH for RP101, a first-in-class, orally-administered Hsp27
inhibitor, for an additional nine months period until May 2017. The Company
intends to conduct additional nonclinical studies with RP101 before
concluding whether to advance its development or terminate the option
agreement with RESprotect GmbH.

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 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(®) (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((TM)) (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; (vii) RP101 - currently subject to an
option-to-acquire by RedHill, RP101 is a Phase II-stage first-in-class, orally-
administered Hsp27 inhibitor, , targeting pancreatic and other gastrointestinal
cancers; (viii) 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; 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.

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




This announcement is distributed by GlobeNewswire on behalf of
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.

Source: RedHill Biopharma Ltd. via GlobeNewswire
[HUG#2034667]

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Datum: 11.08.2016 - 15:00 Uhr
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