Bli medlem
Bli medlem

Du är här

2016-11-03

RedHill Biopharma Ltd. : RedHill Biopharma Provides Update on Ongoing Phase III and Phase II studies with BEKINDA® and Expected Timing of Top-Line Results

* Top-line results from both the ongoing Phase III clinical study for acute
gastroenteritis and gastritis and the ongoing Phase II clinical study for
diarrhea-predominant irritable bowel syndrome (IBS-D) are expected in
mid-2017
* Over two-thirds of the planned total of 320 subjects have been enrolled to
date in the Phase III clinical study with BEKINDA ® 24 mg for acute
gastroenteritis and gastritis in the U.S. (the GUARD study)
* Approximately half of the planned total of 120 subjects have been enrolled
to date in the Phase II clinical study with BEKINDA ® 12 mg for the
treatment of IBS-D in the U.S.
* Worldwide potential market for gastroenteritis and gastritis treatments are
estimated to exceed $650 million annually
* U.S. potential market for IBS-D treatments is estimated to exceed $1.3
billion by 2020

TEL-AVIV, Israel, Nov. 03, 2016 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd.
(NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), a biopharmaceutical
company primarily focused on the 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 its ongoing Phase III and Phase II clinical studies with BEKINDA®
for the treatment of acute gastroenteritis and gastritis and for
diarrhea-predominant irritable bowel syndrome (IBS-D), respectively.

BEKINDA® is a proprietary, extended-release, once-daily oral pill formulation
of the antiemetic drug ondansetron, targeting multiple gastrointestinal
indications. A Phase III study with BEKINDA® 24 mg for acute gastroenteritis
and gastritis is ongoing in the U.S. (the GUARD study). A Phase II study with
BEKINDA® 12 mg is also ongoing in the U.S. for the treatment of
diarrhea-predominant irritable bowel syndrome (IBS-D). Top-line results from
both studies are expected in mid-2017.

Acute gastroenteritis and gastritis - Phase III study

The ongoing randomized, double-blind, placebo-controlled GUARD Phase III study
with BEKINDA® 24 mg for acute gastroenteritis and gastritis is being
conducted at up to 30 sites in the U.S. and is enrolling adults and children
over the age of 12 who suffer from acute gastroenteritis and gastritis. 226
subjects, over two-thirds of the planned total of 320 subjects, have been
enrolled in the study to date, and top-line results are expected in mid-2017.

The primary endpoint for the study is the absence of vomiting and the absence
of the need for rescue medications or intravenous hydration after 30 minutes
and through 24 hours after the first dose of the study medication. Secondary
endpoints include, among others, frequency of vomiting, severity and time to
resolution of nausea and time to resumption of normal activities.

As previously announced, in light of discussions with the FDA RedHill believes
that, subject to achieving highly significant positive results, the Phase III
GUARD study may be sufficient as a single study to support potential future
marketing applications in the U.S., conditional upon, among other things,
future review and guidance from the FDA.

BEKINDA® is intended to provide patients with relief from nausea and vomiting
symptoms for a full 24-hour period with a single oral tablet and, if
approved, may also reduce the burden on health systems by reducing hospital
readmissions.

According to one estimate, there are over 179 million cases of gastroenteritis
and gastritis annually in the U.S. alone1. The worldwide potential market for
gastroenteritis and gastritis treatments is estimated to exceed $650 million
annually2.

IBS-D - Phase II study

The ongoing randomized, double-blind, placebo-controlled Phase II clinical
study is intended to evaluate the safety and efficacy of BEKINDA® 12 mg in
adults over the age of 18 who suffer from IBS-D, at up to 16 clinical sites
in the U.S. Approximately half of the total 120 planned subjects have been
enrolled in the study to date, and top-line results are expected in mid-2017.

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.

IBS is one of the most common gastrointestinal disorders. It is estimated that
at least 30 million Americans suffer from IBS3, 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 20204.

5-HT3 antagonists such as ondansetron, the active pharmaceutical ingredient in
BEKINDA®, have been shown to slow intestinal transit time in humans5.
Alosetron (Lotronex®), 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 effects6. Ondansetron, approved by the FDA as an oncology support
antiemetic, has demonstrated activity in IBS-D in preliminary studies7 and,
in light of its good safety profile, RedHill believes that BEKINDA®, if
approved, has the potential to be a preferred once-daily treatment for a
broad segment of patients suffering from IBS-D.

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. A
Phase III clinical study of BEKINDA® 24 mg formulation for acute
gastroenteritis and gastritis (the GUARD study) is ongoing in the U.S., with
top-line results expected in mid-2017. A Phase II study with BEKINDA® 12 mg
formulation is ongoing in the U.S. for the treatment of diarrhea-predominant
irritable bowel syndrome (IBS-D), with top-line results expected in mid-2017.
RedHill is also pursuing a potential marketing approval of BEKINDA® 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: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 im...

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.