RedHill Biopharma Initiates Phase II Study of BEKINDA(TM) for Irritable Bowel Syndrome
(Thomson Reuters ONE) -
* The randomized, double-blind, 2-arm parallel group Phase II study of
BEKINDA(TM) 12 mg is expected to enroll 120 patients suffering from
diarrhea-predominant irritable bowel syndrome (IBS-D) in 12 clinical sites
in the U.S.
* The U.S. potential market for IBS-D treatments is estimated to exceed $1.3
billion by 2020
* A Phase III study with BEKINDA(TM) 24 mg for acute gastroenteritis and
gastritis is ongoing in the U.S., with top-line results expected in the
second half of 2016
TEL-AVIV, Israel, April 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 inflammatory
and gastrointestinal diseases, including cancer, today announced that it has
initiated a randomized, double-blind, 2-arm parallel group Phase II clinical
study in the U.S. evaluating the safety and efficacy of BEKINDA(TM) 12 mg in
patients with diarrhea-predominant irritable bowel syndrome (IBS-D).
"We are excited to initiate this study of BEKINDA(TM) for IBS-D, a debilitating
disorder affecting millions of people worldwide with few approved therapies and
a significant unmet medical need," said Gilead Raday, RedHill's Chief Operating
Officer. "This study follows publications demonstrating that ondansetron, the
active ingredient in BEKINDA(TM), may be an effective and safe treatment for
IBS-D. We also continue to advance the Phase III GUARD study of BEKINDA(TM) for
acute gastroenteritis and gastritis, currently ongoing in the U.S., with top-
line results expected during the second half of this year."
BEKINDA(TM) is a proprietary, extended-release, once-daily oral pill formulation
of the antiemetic drug ondansetron, targeting multiple gastrointestinal
indications. RedHill is pursuing clinical studies with two dose strengths of
BEKINDA(TM), a 24 mg dose and a 12 mg dose. 5-HT3 antagonists such as
ondansetron, the active pharmaceutical ingredient in BEKINDA(TM), have been
shown to slow intestinal transit time in humans1. Alosetron (Lotronex®), a 5-HT3
antagonist of the same class of drugs as ondansetron, the active ingredient in
BEKINDA(TM), 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 effects2. Ondansetron, approved by the U.S. FDA as an oncology
support antiemetic, has demonstrated activity in IBS-D in preliminary
studies3 and, in light of its good safety profile, RedHill believes that
BEKINDA(TM), if approved, has the potential to be a preferred once-daily
treatment for a broad segment of patients suffering from IBS-D.
The randomized, double-blind, 2-arm parallel group Phase II clinical study is
designed to evaluate the safety and efficacy of BEKINDA(TM) 12 mg in patients
suffering from IBS-D. The study is expected to be conducted in 12 clinical sites
in the U.S. and to enroll 120 patients who will be randomized 60:40 to receive
either BEKINDA(TM) 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.
Irritable bowel syndrome (IBS) is a chronic multifactorial disorder
characterized by recurrent abdominal pain or discomfort associated with altered
bowel function. Diarrhea-predominant irritable bowel syndrome (IBS-D) is the
most common subtype of IBS in the U.S.4 Certain factors that may alter
gastrointestinal function can contribute to IBS symptoms, including stress,
prior gastroenteritis and changes in the gut microbiome. However, the etiology
of IBS is not well-understood and the underlying cause of IBS in many cases
remains unknown. IBS negatively impacts patients' health-related quality of life
and can affect patients physically, emotionally, socially and economically.
IBS is one of the most common GI disorders; it is estimated that at least 30
million Americans suffer from IBS5, 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 20206.
About BEKINDA(TM) (RHB-102):
BEKINDA(TM) is a patent-protected, extended-release (24 hours) oral pill
formulation of ondansetron. A Phase III clinical study of BEKINDA(TM) for acute
gastroenteritis and gastritis (the GUARD study) is ongoing in the U.S., with
top-line results expected in the second half of 2016. A Phase II study has been
initiated with BEKINDA(TM) for the treatment of diarrhea-predominant irritable
bowel syndrome (IBS-D). RedHill is also pursuing marketing approval of
BEKINDA(TM) 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 inflammatory and gastrointestinal
diseases, including 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(TM) (RHB-102) - a once-
daily oral pill formulation of ondansetron with an ongoing Phase III study in
the U.S. for acute gastroenteritis and gastritis and a Phase II study for IBS-D;
(iv) RHB-106 - an encapsulated bowel preparation licensed to Salix
Pharmaceuticals, Ltd.; (v) YELIVA(TM) (ABC294640) - an orally-administered
first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory
and gastrointestinal indications with a Phase I/II study initiated for
refractory/relapsed diffuse large B-cell lymphoma (DLBCL); (vi) MESUPRON® - a
Phase II-stage first-in-class uPA inhibitor, administered by oral capsule,
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 Hsp27 inhibitor, administered by oral tablet, targeting pancreatic and
other gastrointestinal cancers; (viii) RIZAPORT(TM) (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.
1 Garsed K. et al, A randomised trial of ondansetron for the treatment of
irritable bowel syndrome with diarrhoea, Gut (2014), 63(10): 1617-25.
2 www.fda.gov, post market drug safety information for patients and providers.
3 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.
4 GlobalData PharmaPoint: Irritable Bowel Syndrome - Global Drug Forecast and
Market Analysis to 2023.
5 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.
6 EvaluatePharma - Irritable bowel syndrome Indication Profile
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
GlobeNewswire clients. The owner of this announcement warrants that:
(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#2002406]
Datum: 11.04.2016 - 15:00 Uhr
Sprache: Deutsch
News-ID 463095
Anzahl Zeichen: 14372
contact information:
Town:
Tel-Aviv
Kategorie:
Business News
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