- A first randomized,
double-blind, placebo-controlled Phase III clinical study with
RHB-104 for the treatment of Crohn's disease (the MAP US study) is
ongoing in the U.S. and additional countries
- The open-label extension
study (the MAP US2 study) is intended to assess the safety and
efficacy of RHB-104 in patients who have completed 26 weeks of
treatment in the ongoing MAP US Phase III study and remain with
active Crohn's disease (CDAI>150); these patients have the
opportunity to receive treatment with RHB-104 for a 52-week period
in the open-label extension study
- The MAP US2 open-label
extension study is considered separate from the ongoing MAP US
Phase III study and data collected will be supplemental to the MAP
US study data
- A second independent DSMB
meeting for the MAP US Phase III study is expected in mid-2017,
including an interim efficacy analysis and an evaluation of an
option for early stop for success for overwhelming
efficacy
- RHB-104 is a proprietary,
orally-administered, potentially groundbreaking antibiotic
combination therapy with potent intracellular, antimycobacterial
and anti-inflammatory properties
TEL-AVIV, Israel, March 21, 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 dosing of the
first patient in the open-label extension study to the Phase III
study with RHB-104 for the treatment of Crohn's Disease (the MAP US
study).
RHB-104 is a proprietary,
orally-administered, potentially groundbreaking antibiotic
combination therapy with potent intracellular, antimycobacterial
and anti-inflammatory properties.
The MAP US study is a randomized,
double-blind, placebo-controlled first Phase III study, intended to
evaluate the safety and efficacy of RHB-104 in patients with
moderately to severely-active Crohn's disease (defined as Crohn's
Disease Activity Index (CDAI) between 220 and 450). To date, 266
patients out of a planned total of 410 patients have been enrolled
in the study, which is being conducted in up to 150 clinical sites
in the U.S, Canada, Europe, Israel, Australia and New Zealand. A
long-term population pharmacokinetic (pop-PK) study is also ongoing
as part of the MAP US study. Additional studies will be required to
support a U.S. New Drug Application (NDA) for RHB-104.
The open-label extension study
(the MAP US2 study) is intended to assess the safety and efficacy
of RHB-104 in patients who have completed 26 weeks of treatment in
the ongoing MAP US Phase III study and remain with active Crohn's
disease (CDAI>150) at week 26, the MAP US study's primary
endpoint. These patients have the opportunity to receive treatment
with RHB-104 for a 52-week period in the open-label extension
study. This study is considered separate from the ongoing MAP US
Phase III study, and data collected will be supplemental to the MAP
US study data. The open-label extension study's primary endpoint is
disease remission at week 16, defined as CDAI less than 150. The
open-label extension MAP US2 study is planned to enroll
approximately 100 subjects in up to 150 clinical sites in the U.S.,
Canada, Europe, Israel, Australia and New Zealand. Additional
open-label studies with RHB-104 for Crohn's disease are being
planned by RedHill, to provide further supportive clinical data for
potential future marketing applications.
A second independent Data and
Safety Monitoring Board (DSMB) meeting of the MAP US Phase III
study, expected in mid-2017, will include an interim efficacy
analysis and will evaluate the option for an early stop for success
for overwhelming efficacy, according to a pre-specified statistical
significance threshold. Assuming the study is not stopped for
success or inefficacy following the DSMB meeting in mid-2017,
completion of recruitment for the MAP US study is expected by the
end of 2017. In December 2016, a first, pre-planned independent
DSMB meeting reviewed safety data from the ongoing MAP US study and
provided a unanimous recommendation to continue the study as
planned.
The development of RHB-104 is
based on increasing evidence supporting the hypothesis that Crohn's
disease, and potentially other autoimmune diseases, are related
to Mycobacterium avium subspecies
paratuberculosis (MAP) infection in susceptible patients.
The development of RHB-104 is consistent with the growing awareness
of the possibility that a bacterially-induced dysregulated immune
system may contribute to the pathogenesis of various autoimmune
diseases of unknown etiology.
The MAP US Phase III study is 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
RHB-104:
Currently in a first Phase III study for the treatment of Crohn's
disease (the MAP US study), RHB-104 is a proprietary,
orally-administered, potentially groundbreaking oral antibiotic
combination therapy, with potent intracellular, antimycobacterial
and anti-inflammatory properties. RHB-104 is based on increasing
evidence supporting the hypothesis that Crohn's disease is caused
by Mycobacterium avium subspecies
paratuberculosis (MAP) infection in susceptible patients.
Clinical trials conducted with earlier formulations of RHB-104
include an Australian Phase III study conducted by
Pharmacia/Pfizer. RedHill has conducted several supportive studies
with the current formulation of RHB-104 and a long-term population
pharmacokinetic (pop-PK) study is ongoing as part of the Phase III
MAP US study. Additionally, an open-label extension study (the MAP
US2 study) is ongoing to assess the safety and efficacy of RHB-104
in patients who have completed 26 weeks of treatment in the ongoing
Phase III MAP US study and remain with active Crohn's disease
(CDAI>150) at week 26. RHB-104 is covered by several issued and
pending patents. RedHill has also completed a Phase IIa,
proof-of-concept clinical study, evaluating RHB-104 as an add-on
therapy to interferon beta-1a in patients treated for
relapsing-remitting multiple sclerosis (the CEASE MS study).
Top-line final results from the CEASE MS study suggest meaningful
positive safety and clinical signals upon 24 weeks of treatment
with RHB-104 as an add-on therapy, thereby supporting further
clinical development.
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 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 Germany in October
2015. 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®, (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.
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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