- The independent Data and
Safety Monitoring Board (DSMB) reviewed safety and efficacy data,
of which RedHill remains blinded, from the first 222 subjects who
have completed week 26 assessments in the Phase III MAP US
study
- To date, over 300 of the
planned 410 subjects, have been randomized in the Phase III MAP US
study
- An open-label extension
Phase III study (the MAP US2 study) is ongoing in parallel in
patients who remain out of remission after 26 weeks of blinded
study therapy in the MAP US study
TEL-AVIV, Israel and RALEIGH,
N.C., July 31, 2017 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd.
(NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the
"Company"), a specialty biopharmaceutical company primarily focused
on late clinical-stage development and commercialization of
proprietary, orally-administered, small molecule drugs for
gastrointestinal and inflammatory diseases and cancer, today
reported, following a second pre-planned meeting to assess the
safety and efficacy data from its ongoing first Phase III study
with RHB-104 for Crohn's disease (the MAP US study) by an
independent Data and Safety Monitoring Board (DSMB), that it has
received a unanimous positive recommendation from the DSMB to
continue the study as planned.
The independent DSMB reviewed
safety and efficacy data, of which RedHill remains blinded, from
the first 222 subjects who have completed week 26 assessments in
the Phase III MAP US study. In December 2016, a first pre-planned
independent DSMB meeting reviewed safety data from the MAP US study
and provided a unanimous recommendation to continue the study as
planned.
Ira Kalfus, MD, Medical
Director at RedHill, said:
"RHB-104 is a potentially ground-breaking new therapy for Crohn's
disease. The DSMB has reviewed the unblinded interim safety and
activity results of the Phase III MAP US study, and we are very
encouraged by its unanimous recommendation to continue the study
through randomization of all planned 410 subjects, with no changes
to the protocol, investigator's brochure, study conduct or informed
consent form. We continue to enroll subjects and expect to complete
enrollment in the study in the first half of 2018. I would like to
thank the DSMB members for their professional and independent
assessment of the study data and for their positive
recommendation."
RHB-104 is a proprietary,
orally-administered, potentially ground-breaking, antibiotic
combination therapy with potent intracellular, antimycobacterial
and anti-inflammatory properties, targeting a suspected underlying
bacterial infectious cause of Crohn's disease, Mycobacterium avium subspecies
paratuberculosis (MAP).
The MAP US study is a randomized,
double-blind, placebo-controlled first Phase III study evaluating
the safety and efficacy of RHB-104 in patients with moderately to
severely active Crohn's disease (defined as CDAI between 220 and
450). The MAP US study is being conducted in up to 150 clinical
sites in the U.S, Canada, Europe, Israel, Australia and New
Zealand. Additional clinical data will need to be generated to
support a U.S. New Drug Application (NDA) for RHB-104. The primary
endpoint of the MAP US study is disease remission, defined as a
reduction in Crohn's Disease Activity Index (CDAI) to less than 150
at week 26.
To date, over 300 of the planned
410 subjects, have been randomized in the MAP US study. A third,
safety-focused, independent DSMB meeting is expected to be held
when 75% of the planned 410 subjects have completed 26 weeks of
study participation. Completion of recruitment for the MAP US study
is expected in the first half of 2018.
Additionally, an open-label
extension Phase III study (the MAP US2 study) is ongoing to further
assess the safety and efficacy of RHB-104 in patients who
remain out of remission (CDAI greater than or equal to 150)
after 26 weeks of blinded study therapy in the ongoing Phase III
MAP US study.
The clinical studies with RHB-104 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
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 ground-breaking 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 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. 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 Phase III study (the MAP US2 study) is ongoing to assess
the safety and efficacy of RHB-104 in subjects who have
completed week 26 assessments in the ongoing Phase III MAP US study
and remain with active Crohn's disease (CDAI greater than or
equal to 150) at week 26. RHB-104 is covered by several issued
and pending patents. RedHill also completed a Phase IIa,
proof-of-concept clinical study, evaluating RHB-104 as an add-on
therapy to interferon beta-1a in subjects treated for
relapsing-remitting multiple sclerosis (the CEASE MS study), with
top-line final results suggesting meaningful positive safety and
clinical signals upon 24 weeks of treatment with RHB-104 as an
add-on therapy, thereby supporting further clinical development.
RHB-104 was granted Qualified Infectious Disease Product (QIDP)
designation by the U.S. FDA for the treatment of nontuberculous
mycobacteria (NTM) infections, providing a Fast-Track development
pathway, as well as NDA Priority Review and an additional five
years of U.S. market exclusivity, if approved. RedHill is in
discussions with the FDA regarding the development of RHB-104
development program for NTM infections.
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 promotes two gastrointestinal products
in the U.S. - Donnatal®, a
prescription oral adjunctive drug used in the treatment of IBS and
acute enterocolitis, and 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) TALICIA(TM) (RHB-105) - an
oral combination therapy for the treatment of Helicobacter pylori infection with successful
results from a first Phase III study and an ongoing confirmatory
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 successful
top-line results in a 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) the Company's
Expanded Access Program, which allows patients with
life-threatening diseases potential access, subject to regulatory
and other approvals, to RedHill's investigational new drugs that
have not yet received regulatory marketing approval, if a patient
suffers an adverse experience using such investigative drug,
potentially adversely affecting the clinical development program of
that investigational product or the Company generally; (xiv)
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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