- Top-line results are
expected in the third quarter of 2017
- The randomized,
double-blind, placebo-controlled Phase II study is evaluating the
safety and efficacy of BEKINDA® (RHB-102)
12 mg in 127 U.S. patients with diarrhea-predominant irritable
bowel syndrome (IBS-D)
- IBS is one of the most
common gastrointestinal disorders; it is estimated that at least 30
million Americans suffer from IBS, of which over 40% are cases of
IBS-D
- If approved,
BEKINDA® 12 mg
has the potential to be a preferred once-daily treatment for a
broad segment of patients suffering from
IBS-D, targeting a U.S.
potential market estimated to exceed $1 billion
by 2022
- Top-line results from a
Phase III study with BEKINDA® 24 mg
for acute gastroenteritis and gastritis (the GUARD study) are
expected in the second quarter of 2017
- RedHill will host an
R&D Day and live webcast on BEKINDA® on
Thursday, April 27, 2017 in NYC, discussing the product,
indications, potential markets and the ongoing Phase III and II
studies for acute gastroenteritis and IBS-D,
respectively
TEL-AVIV, Israel, April 24, 2017
(GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv
Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty
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 announced enrollment of the
last patient in the Phase II study with BEKINDA® (RHB-102)1 12
mg for the treatment of diarrhea-predominant irritable bowel
syndrome (IBS-D).
BEKINDA® is a
proprietary, bimodal extended-release, once-daily oral pill
formulation of ondansetron, targeting several gastrointestinal
indications.
The randomized, double-blind,
placebo-controlled Phase II study is evaluating the safety and
efficacy of BEKINDA® 12 mg in
adults over the age of 18 with IBS-D. The study enrolled 127
subjects in 16 U.S. clinical sites. Top-line results are expected
in the third quarter of 2017.
Subjects enrolled in the Phase II
IBS-D study were randomized 60:40 to receive either
BEKINDA® 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.
IBS is one of the most common
gastrointestinal disorders2. It is
estimated that at least 30 million Americans suffer from
IBS3, of which
over 40% are cases of IBS-D4. The U.S.
potential market for IBS-D treatments is estimated to exceed $1
billion by 20225.
5-HT3 antagonists such as
ondansetron, the active pharmaceutical ingredient in
BEKINDA®, have been
shown to slow intestinal transit time in humans6.
Alosetron (Lotronex®), a 5-HT3
antagonist of the same class of drugs as ondansetron, has been
approved by the FDA for the treatment of women with severe chronic
IBS-D, but is under a restricted prescribing (REMS) program due to
potential severe side effects7. Ondansetron,
approved by the FDA as an oncology support antiemetic, has
demonstrated activity in IBS-D in preliminary studies8 and, in
light of its 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.
Top-line results from the Phase
III study with BEKINDA® 24 mg
for acute gastroenteritis and gastritis (the GUARD study) are
expected in the second quarter of 2017. In February 2017, RedHill
announced that the last patient had completed the treatment course
and observation period in the randomized, double-blind,
placebo-controlled GUARD study, which treated 320 adults and
children over the age of 12 in 29 U.S. clinical sites.
The Phase II study and the Phase
III GUARD study with BEKINDA® are
registered on www.ClinicalTrials.gov, a web-based service
of the U.S. National Institutes of Health, which provides access to
information on publicly and privately supported clinical
studies.
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 patient treatment course and
observation period completed and top-line results expected in the
second quarter of 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 patient
enrollment completed and top-line results expected in the third
quarter of 2017.
About
RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL)
is a specialty 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 has a U.S. co-promotion agreement with
Concordia for Donnatal®, a
prescription oral adjunctive drug used in the treatment of IBS and
acute enterocolitis, as well as an exclusive license agreement with
Entera Health for EnteraGam®, a
medical food intended for the dietary management, under medical
supervision, of chronic diarrhea and loose stools. RedHill's
clinical-stage pipeline 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,
a completed proof-of-concept Phase IIa study for multiple sclerosis
and QIDP status for nontuberculous mycobacteria (NTM) infections;
(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 protease inhibitor, targeting pancreatic cancer
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 two EU member
states under the European Decentralized Procedure (DCP). More
information about the Company is available
at: www.redhillbio.com.
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 successfully market Donnatal® and
EnteraGam®, (vi) the
Company's ability to establish and maintain corporate
collaborations; (vii) 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;
(viii) 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; (ix) the implementation of the Company's business
model, strategic plans for its business and therapeutic candidates;
(x) 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; (xi) parties
from whom the Company licenses its intellectual property defaulting
in their obligations to the Company; and (xii) estimates of the
Company's expenses, future revenues capital requirements and the
Company's needs for additional financing; (xiii) competitive
companies and technologies within the Company's industry. 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 23,
2017. 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.
_________________________
1 BEKINDA® is
an investigational new drug, not available for commercial
distribution.
2 GlobalData
PharmaPoint: Irritable Bowel Syndrome - Global Drug Forecast and
Market Analysis to 2023.
3 Lovell
RM, Ford AC, Global prevalence of and risk factors for irritable
bowel syndrome: a meta-analysis, Clin Gastroenterol Hepatol (2012),
10(7)712-721; Saito YA et al, The epidemiology of irritable bowel
syndrome in North America: a systemic review, Am J Gastroenterol
(2002), 97(8): 1910-5.
4 GlobalData
PharmaPoint: Irritable Bowel Syndrome - Global Drug Forecast and
Market Analysis to 2023.
5 EvaluatePharma
- Irritable bowel syndrome Indication
Profile.
6 Garsed
K. et al, A randomised trial of ondansetron for the treatment of
irritable bowel syndrome with diarrhoea, Gut (2014), 63(10):
1617-25.
7 www.fda.gov,
post market drug safety information for patients and providers.
8 Steadman
CJ et al, Selective 5-hydroxytryptamine type 3 receptor antagonism
with ondansetron as treatment for diarrhea-predominant irritable
bowel syndrome: a pilot study, Mayo Clin Proc (1992),
67(8):732-8; Clayton NM et al, The pharmacological properties
of the novel selective 5-HT3 receptor antagonist, alosetron, and
its effects on normal and perturbed small intestinal transit in the
fasted rat, Neurogastroenterol (1999), 11: 207-217; Garsed K. et
al, A randomised trial of ondansetron for the treatment of
irritable bowel syndrome with diarrhoea, Gut (2014), 63(10):
1617-25.
Company contact:
Adi Frish
Senior VP Business Development &
Licensing
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
IR contact (U.S.):
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus@troutgroup.com
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: RedHill Biopharma Ltd. via Globenewswire
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