RedHill Biopharma Announces Enrollment of Last Patient in BEKINDA® Phase III Study for Acute Gastroenteritis
(Thomson Reuters ONE) -
* Top-line results are expected in the second quarter of 2017
* The randomized, double-blind, placebo-controlled Phase III study is
evaluating the safety and efficacy of BEKINDA(®) 24mg in patients with acute
gastroenteritis and gastritis (the GUARD study)
* Acute gastroenteritis and gastritis are inflammations of the mucus membranes
of the gastrointestinal tract which may lead to nausea, vomiting, diarrhea
or abdominal pain; Acute gastroenteritis is a common infectious disease,
with approximately 179 million cases annually in the U.S.
* If approved, BEKINDA(®) could become the first 5-HT3 antiemetic drug in the
U.S. indicated for the treatment of acute gastroenteritis and gastritis,
targeting a potential worldwide market estimated to exceed $650 million
annually
* Additionally, a Phase II study with BEKINDA(®) 12 mg 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
TEL-AVIV, Israel,, Feb. 13, 2017 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd.
(NASDAQ:RDHL) (TASE: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 III study with
BEKINDA(®) 24 mg for the treatment of acute gastroenteritis and gastritis (the
GUARD study).
The randomized, double-blind, placebo-controlled Phase III GUARD study with
BEKINDA(® )24 mg is conducted in 29 U.S. clinical sites and treated 320 adults
and children over the age of 12 who suffered from acute gastroenteritis and
gastritis. Top-line results are expected in the second quarter of 2017.
Robert A. Silverman, MD, MS, Emergency Medicine specialist at the Hofstra North
Shore-LIJ Medical Center, and Associate Professor at the Hofstra North Shore-LIJ
School of Medicine in New York, is the lead investigator for the study.
BEKINDA(®) is a proprietary, bimodal extended-release, once-daily oral pill
formulation of the antiemetic drug ondansetron, targeting multiple
gastrointestinal indications. BEKINDA(® )is intended to provide patients with
relief from nausea and vomiting symptoms for a full 24-hour period with a single
oral tablet.
The primary endpoint for the GUARD study is the absence of vomiting or the need
for rescue medications or intravenous hydration from 30 minutes through 24 hours
after the first dose of the study drug. 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 U.S. Food and Drug
Administration (FDA), RedHill believes that, subject to achieving highly
significant positive results, the Phase III GUARD study may be sufficient as a
single Phase III study to support potential future marketing application in the
U.S., conditional upon, among other things, future review and guidance from the
FDA.
Acute gastroenteritis and gastritis are inflammations of the mucus membranes of
the gastrointestinal tract leading to a combination of symptoms which include
nausea, vomiting, diarrhea or abdominal pain. Acute gastroenteritis is a common
infectious disease, with approximately 179 million cases annually in the
U.S.(1). It is caused by many different infectious agents, most commonly by
viral infections, accounting for up to 70% of cases. Noroviruses cause the most
outbreaks of non-bacterial acute gastroenteritis in all age groups and often
occur in epidemic outbreaks in schools, nursing homes and other group
settings(2). Gastroenteritis and gastritis are major causes of emergency room
visits, with up to 474,000 estimated hospitalizations annually in the U.S.
alone(1). Dehydration is the most frequent and dangerous complication of acute
gastroenteritis(3). Oral rehydration is the preferred therapy in mild to
moderate dehydration, whereas intravenous fluids are recommended in more severe
cases(4). Adding ondansetron, the active ingredient in BEKINDA(®), to the
standard intravenous rehydration therapy has shown to significantly reduce the
amount of vomiting in children with gastroenteritis(3), however, to the best of
RedHill's knowledge, its efficacy in adults has not been studied in a randomized
clinical trial in the U.S.
Ondansetron is used as an antiemetic in patients suffering from chemotherapy and
radiotherapy-induced nausea and vomiting and from postoperative nausea and
vomiting(5). BEKINDA(®) may decrease the frequency of vomiting, improve the
success and compliance of oral rehydration therapy and decrease the rate of
intravenous therapy in patients suffering from gastroenteritis. It may also
decrease the number of emergency room visits, and therefore reduce health care
costs. If approved for marketing by the FDA, BEKINDA® could become the first 5-
HT3 antiemetic drug in the U.S. indicated for the treatment of acute
gastroenteritis and gastritis, targeting a potential worldwide market estimated
to exceed $650 million annually(6).
BEKINDA(®) is being studied for additional indications. A randomized, double-
blind, placebo-controlled Phase II study with BEKINDA(®) 12 mg is currently
ongoing in the U.S. for the treatment of diarrhea-predominant irritable bowel
syndrome (IBS-D). The Phase II study is evaluating the safety and efficacy of
BEKINDA(® )12 mg in adults over the age of 18 who suffer from IBS-D at 16
clinical sites in the U.S. 96 of the planned total of 120 subjects have been
enrolled to date. Top-line results are expected in mid-2017.
The Phase III GUARD study and the Phase II 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 enrollment 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 top-line results expected in mid-2017.
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE: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. 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 uPA inhibitor, targeting gastrointestinal 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 Germany in October 2015. More
information about the Company is available at: www.redhillbio.com.
(1) Scallan E, Griffin PM, Angulo FJ, Tauxe RV, Hoekstra RM, Foodborne Illness
Acquired in the United States - Unspecified Agents, Emerg Infect Dis.
2011;17(1):16-22.
(2) Graves S. Nancy, Acute Gastroenteritis, Prim Care Clin Office Pract 40
(2013) 727-741.
(3) Elliott, Elizabeth Jane, Acute Gastroenteritis in Children, BMJ, 334.7583
(2007): 35-40. PMC. Web. 8 Feb. 2017.
(4) Reeves JJ, Shannon MW, Fleisher GR, Ondansetron decreases vomiting
associated with acute gastroenteritis: a randomized, controlled trial,
Pediatrics. 2002;109(4):e62.
(5) Ondansetron prescribing information
(6) Graves S. Nancy, Acute Gastroenteritis, Prim Care Clin Office Pract 40
(2013) 727-741.
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 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: 13.02.2017 - 14:00 Uhr
Sprache: Deutsch
News-ID 523725
Anzahl Zeichen: 14429
contact information:
Town:
Tel-Aviv
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 226 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"RedHill Biopharma Announces Enrollment of Last Patient in BEKINDA® Phase III Study for Acute Gastroenteritis"
steht unter der journalistisch-redaktionellen Verantwortung von
RedHill Biopharma Ltd. (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
