RedHill Biopharma Provides Update on Progress With RHB-104 Ongoing Phase III Program for Crohn's Disease Following FDA Meetin...
29 Januar 2015 - 1:13PM
- RedHill and Quest Diagnostics concluded a
pre-submission meeting with U.S. FDA regarding RedHill's companion
diagnostic test for the detection of MAP bacterium, an extension of
RedHill's ongoing RHB-104 Phase III Crohn's disease development
program
- Increasing evidence supports the hypothesis that
Crohn's disease is caused by MAP infection in susceptible patients;
Based of FDA's feedback, RedHill and Quest Diagnostics plan to
commence a study to assess the clinical utility of the diagnostic
test in Q2-Q3/2015
- A protocol amendment for the ongoing Phase III study of
RHB-104 in Crohn's disease has been filed with FDA and is expected
to significantly increase the number of patients eligible to enroll
in this study
- The RHB-104 Phase III MAP US study for Crohn's disease
is one of RedHill's three ongoing Phase III studies in the U.S.
with three of its drug candidates targeting gastrointestinal
diseases
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) ("RedHill" or the
"Company"), an Israeli biopharmaceutical company primarily focused
on late clinical-stage, proprietary, orally-administered drugs for
inflammatory and gastrointestinal diseases, including
gastrointestinal cancers, today provided an update on the progress
with the ongoing RHB-104 Phase III development program for the
treatment of Crohn's disease. The Company, together with Quest
Diagnostics, recently concluded a pre-submission meeting with the
FDA regarding the development path of a commercial companion
diagnostic test for the detection of Mycobacterium avium subspecies
paratuberculosis (MAP) in Crohn's disease patients. Following the
constructive FDA meeting, RedHill intends to initiate a study of
approximately 40 Crohn's disease patients to assess the clinical
utility of the companion diagnostic test during the second or third
quarter of 2015.
RedHill is collaborating with Quest Diagnostics for the
development of the potential companion diagnostic test, which is an
extension of RedHill's development program for the Company's
Crohn's disease drug, RHB-104, currently undergoing a first Phase
III study (the MAP US study). RHB-104 is a proprietary and
potentially groundbreaking antibiotic combination therapy in oral
capsule formulation, with potent intracellular, antimycobacterial
and anti-inflammatory properties. The development of RHB-104 and
the MAP companion diagnostic test is based on increasing evidence
supporting the hypothesis that Crohn's disease is caused by MAP
infection in susceptible patients. RedHill previously announced
that it acquired the rights to patented technologies from the
University of Minnesota and the University of Central Florida to
support the development of this diagnostic test. There is currently
no validated, FDA-approved, commercially available method of
detecting the presence or absence of MAP in patients suffering from
Crohn's disease and other diseases.
RedHill further announced that a protocol amendment has been
filed with the FDA to the approved IND in relation to the ongoing
Phase III MAP US study with RHB-104 for the treatment of Crohn's
disease. As part of the amendment, the number of subjects planned
to be enrolled in the study has been increased from 240 to 270 in
order to account for potential drop-outs from the study.
Additionally, the amendment allows for the inclusion of Crohn's
disease patients with moderate to severe disease despite current
treatment with anti-Tumor Necrosis Factor (anti-TNF) therapies
infliximab (Remicade®) and adalimumab (Humira®). The inclusion of
these concomitant medications significantly increases the number of
Crohn's disease patients potentially eligible to enroll in the
ongoing Phase III MAP US study. With 66 clinical sites actively
enrolling patients, RedHill also plans to increase the number of
clinical sites in the Phase III MAP US study, currently ongoing in
the U.S., Canada and Israel, from 100 to 120, including new sites
in Australia, New Zealand and Europe.
Ira Kalfus, MD, RedHill's Medical Director,
said: "We would like to thank CDRH, the FDA's Center for
Devices and Radiological Health, for the recent meeting regarding
the development path for the MAP companion diagnostic test. In
addition, we believe the filed protocol amendment of the MAP US
study with RHB-104 will significantly increase the eligible patient
population for our ongoing Crohn's disease study. We are working
diligently to develop this potentially groundbreaking therapy for
the patients affected by this disease. The filed protocol amendment
of the MAP US study in Crohn's disease will be presented at a North
American investigator meeting next week, with similar meetings
planned for Israel, Australia, New Zealand and Europe."
The RHB-104 Phase III MAP US study for Crohn's disease is one of
RedHill's three ongoing Phase III studies in the U.S. targeting
gastrointestinal diseases, together with the RHB-105 Phase III
study (the ERADICATE Hp study) for the treatment of H. pylori
infection (top-line results expected during the second quarter of
2015) and the RHB-102 (BEKINDA™) Phase III study (the GUARD Study)
for gastroenteritis and gastritis (top-line results expected
H2/2015).
The MAP US Phase III study is registered on ClinicalTrials.gov,
a web-based service by the U.S. National Institute of Health which
provides public access to information on publicly and privately
supported clinical studies:
https://clinicaltrials.gov/ct2/show/NCT01951326.
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 and
potentially groundbreaking antibiotic combination therapy in oral
capsule formulation, 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 the Mycobacterium avium subspecies paratuberculosis (MAP)
infection in susceptible patients. The RHB-104 formulation was
originally developed by Professor Thomas Borody, a leading
innovator of therapeutic approaches for treating gastrointestinal
tract diseases, who also developed the original triple therapy for
peptic ulcer disease associated with H. pylori. Several clinical
trials were conducted with earlier formulations of RHB-104,
including an Australian Phase III study conducted by 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.
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) is an emerging
Israeli biopharmaceutical company focused on the development and
acquisition of late clinical-stage, proprietary,
orally-administered drugs for the treatment of inflammatory and
gastrointestinal diseases, including gastrointestinal cancers.
RedHill's current pipeline of proprietary products includes: (i)
RHB-105 - an oral combination
therapy for the treatment of Helicobacter pylori infection, with an
ongoing 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; (iii)
BEKINDA™ (RHB-102)
- a once-daily oral pill formulation of
ondansetron with a Phase III study in the U.S. for acute
gastroenteritis and gastritis and a European marketing application
for chemotherapy and radiotherapy-induced nausea and vomiting
submitted in December 2014; (iv) RHB-106
- an encapsulated formulation for bowel
preparation licensed to Salix Pharmaceuticals, Ltd.; (v)
MESUPRON® - a Phase II-stage uPA inhibitor,
administered by oral capsule, targeting gastrointestinal and other
solid tumor cancers; (vi) RP101 -
currently subject to an option-to-acquire by RedHill, RP101 is a
Phase II-stage Hsp27 inhibitor, administered by oral tablet,
targeting pancreatic and other gastrointestinal cancers; (vii)
RIZAPORT™ (RHB-103) - an oral
thin film formulation of rizatriptan for acute migraines with a
U.S. NDA currently under discussions with the FDA and a European
marketing application submitted in October 2014; and (viii)
RHB-101 - a once-daily oral pill
formulation of the cardio drug carvedilol. For more information
please visit 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
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 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
interpretation of the properties and characteristics of the
Company's therapeutic candidates and of the results obtained with
its therapeutic candidates in preclinical studies or clinical
trials; (vii) the implementation of the Company's business model,
strategic plans for its business and therapeutic candidates; (viii)
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; (ix) parties
from whom the Company licenses its intellectual property defaulting
in their obligations to the Company; (x) estimates of the Company's
expenses, future revenues capital requirements and the Company's
needs for additional financing; and (xi) 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 25, 2014. 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.
CONTACT: Company contact:
Adi Frish
Senior VP Business Development & Licensing
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
IR contact (U.S.):
Lauren Kwiecinski
Senior Associate
The Trout Group
+1-646-378-2934
lkwiecinski@troutgroup.com
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