RedHill Biopharma Announces Enrollment of Last Patient in the BEKINDA® Phase II Study for IBS-D
(Thomson Reuters ONE) -
* 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 disorders(2). It is estimated
that at least 30 million Americans suffer from IBS(3), of which over 40% are
cases of IBS-D(4). The U.S. potential market for IBS-D treatments is estimated
to exceed $1 billion by 2022(5).
5-HT3 antagonists such as ondansetron, the active pharmaceutical ingredient in
BEKINDA(®), have been shown to slow intestinal transit time in humans(6).
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 effects(7). Ondansetron, approved by the FDA as an
oncology support antiemetic, has demonstrated activity in IBS-D in preliminary
studies(8) 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(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 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
Datum: 24.04.2017 - 13:00 Uhr
Sprache: Deutsch
News-ID 537852
Anzahl Zeichen: 14511
contact information:
Town:
Tel-Aviv
Kategorie:
Business News
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