RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) (“RedHill” or the
“Company”), a 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 that it has received from the Japan Patent Office a
Notice of Allowance for a new patent covering RHB-104 for the
treatment of multiple sclerosis (MS), which is expected to be valid
until 2032, once granted. This notice follows RedHill’s recent
announcement that the counterpart European patent application was
approved by the European Patent Office.
RHB-104 is a proprietary, orally-administered,
potentially groundbreaking antibiotic combination therapy with
potent intracellular, anti-mycobacterial and anti-inflammatory
properties. A first Phase III study with RHB-104 for the treatment
of Crohn’s disease is currently ongoing. RHB-104 is also being
evaluated as a treatment for relapsing-remitting multiple sclerosis
(RRMS), with top-line final results from a Phase IIa
proof-of-concept study expected in the coming weeks (the CEASE-MS
study).
The Phase IIa CEASE-MS open-label study was
initiated following several successful pre-clinical studies
conducted by RedHill and was designed to evaluate RHB-104 as an
add-on therapy to interferon beta-1a in patients treated for RRMS.
Patients enrolled in the study received 24 weeks of treatment with
RHB-104 as an add-on therapy to interferon beta-1a and were then
evaluated for an additional 24-week follow-up period during which
they were treated with interferon beta-1a alone. Top-line interim
results announced in March 2016, after completion of the 24-week
treatment period, demonstrated positive safety and efficacy
signals, including an encouraging relapse-free rate, Expanded
Disability Status Scale (EDSS) scores and MRI results, which
support further clinical development.
RedHill’s robust RHB-104 patent portfolio,
covering its oral antibiotic combination therapy, includes more
than 26 patents in many countries, including the U.S., Australia,
Canada, Japan and multiple European countries with additional
patent claims being pursued.
A first Phase III study with RHB-104 for the
treatment of Crohn’s disease is currently ongoing (the MAP US
study). The randomized, double-blind, placebo-controlled MAP US
study is planned to enroll a total of 410 subjects in up to 150
clinical sites in the U.S., Canada, Europe, Australia, New Zealand
and Israel. A safety-focused independent data and safety monitoring
board (DSMB) meeting is on track to take place in the fourth
quarter of 2016. A second independent DSMB meeting is expected in
the second quarter of 2017, after the first 205 patients complete
26 weeks of study participation. Patient 205 was randomized in
August 2016.
The second DSMB meeting in the MAP US study will
include safety and interim efficacy analysis and could potentially
provide the opportunity to expedite the data locking process for
the final analysis, once the study is complete. Importantly, this
independent DSMB meeting will evaluate the option of an early stop
for success, according to a pre-specified statistical significance
threshold for analysis requiring overwhelming efficacy of RHB-104
versus placebo in the primary endpoint.
RedHill recently announced several improvements
and enhancements to the Phase III Crohn’s disease program to
provide a more comprehensive assessment of RHB-104’s treatment
effect and bolster the likelihood of the study’s success even
further. No changes are planned to the MAP US Phase III study’s
primary endpoint or 90% power. Assuming enrollment of all 410
planned subjects, completion of patient recruitment is expected by
the end of 2017.
The MAP US Phase III study and the CEASE-MS
Phase IIa study 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 Multiple
Sclerosis: Multiple sclerosis (MS)
is a chronic inflammatory, demyelinating disease of the central
nervous system with an unknown etiology, believed to be
multifactorial. A dysfunctional immune system in MS patients causes
recurrent inflammatory attacks on the central nervous system (CNS),
leading to neurological disability. Diffuse inflammatory and
demyelinating lesions, also known as plaques, are the main
pathological finding in MS neural tissue. The lesions are primarily
found in the spinal cord, optic nerves, brainstem and
periventricular white matter. The symptoms of MS are dictated by
the location of the lesions within the CNS. Geographic variation in
MS distribution, which cannot be solely explained by population
genetics, supports the notion that environmental factors also hold
etiological importance. There is currently no known cure for MS and
available treatments are mainly intended to manage or prevent
relapses or reduce symptoms. In 2015, there were estimated to be
over 900,000 diagnosed patients with MS worldwide. Approximately
85% of MS patients initially exhibit relapse-remitting disease
(RRMS). The 2016 U.S. and worldwide sales of MS therapies are
estimated to exceed $12 billion and $18 billion,
respectively1.
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 antibiotic combination therapy, with
potent intracellular, anti-mycobacterial 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. RHB-104 is covered by several issued and pending
patents. RedHill is also conducting the CEASE-MS 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 (RRMS), with top-line
interim results announced and top-line final results expected in
the coming weeks.
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 gastrointestinal and inflammatory
diseases and 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®
(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; (vii)
RP101 - currently subject to an
option-to-acquire by RedHill, RP101 is a Phase II-stage
first-in-class, orally-administered Hsp27 inhibitor, targeting
pancreatic and other gastrointestinal cancers; (viii)
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; 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 GlobalData PharmaPoint report, August 2015.
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
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