RedHill Biopharma Announces Positive Pre-Clinical Results for Lupus With RHB-104
10 September 2013 - 2:00PM
- The Company is assessing the possibility of a Phase IIa
proof of concept study in systemic lupus erythematosus as a next
step
- RedHill expects to commence a Phase III study
with RHB-104 for Crohn's disease
in the U.S. during the third quarter of 2013 (the MAP US study),
and plans a second Phase III study for Crohn's in Europe (the MAP
Europe study)
- Patients recruitment is underway in a Phase IIa study
with RHB-104 for multiple sclerosis (MS)
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL)
(the "Company" or "RedHill"), an emerging Israeli biopharmaceutical
company focused primarily on the development and acquisition of
late clinical-stage, proprietary formulations and combinations of
existing drugs, today announced positive results from a
pre-clinical study with RHB-104 for the treatment of systemic lupus
erythematosus (SLE), a systemic autoimmune disease causing
inflammation and damage to tissues in various parts of the body. In
light of the positive results, the Company is currently assessing
the next steps in the clinical development program, including a
possible Phase IIa clinical study.
The pre-clinical study was designed to evaluate the potential
therapeutic effects of RHB-104 on disease development in an
experimental SLE model when administered orally.
The results from the pre-clinical study demonstrated that
disease severity and overall disease development were reduced in
the RHB-104 arm, indicating that RHB-104 was efficacious in
reducing the development of SLE in this study.
SLE is an autoimmune disease in which the body's immune system
attacks healthy cells and tissues resulting in inflammation and
possible harm to multiple organs and organ systems including
joints, skin, kidneys, blood, brain, heart and lungs. Symptoms of
SLE may vary accordingly. The underlying cause of SLE is unknown
and there is no cure for the disease, thus available therapies are
aimed at controlling the symptoms. Worldwide sales of SLE therapies
are estimated to have exceeded $370 million in 20121.
RHB-104 is a patent protected combination therapy of three
antibiotics in a single oral capsule. It is a multifaceted drug
with potentially distinct anti-inflammatory and neuroprotective
properties, in addition to its antibacterial activity against
intracellular infections. RHB-104 is being evaluated for the
treatment of Crohn's disease - with a phase III clinical study
planned to commence in the third quarter of 2013 in the U.S.,
Canada and Israel (the MAP US study) and a planned Phase III study
in Europe (the MAP Europe study), the treatment of multiple
sclerosis - with an ongoing phase IIa proof of concept study, and
the treatment of rheumatoid arthritis - with a planned Phase IIa
proof of concept study.
Dr. Reza Fathi, RedHill's Senior VP R&D,
commented: "We are very pleased with the results of the
pre-clinical study conducted with RHB-104 in the treatment of
systemic lupus erythematosus. The results of this study are
consistent with the hypothesis that a dysregulated immune system
response to bacterial origin in genetically predisposed individuals
plays a role in the pathogenesis of various autoimmune diseases for
which there is no available cure, such as Crohn's disease, multiple
sclerosis, rheumatoid arthritis and lupus. We are currently
assessing next steps in the development program, including the
possibility of a Phase IIa proof of concept clinical study with
RHB-104 for the treatment of systemic lupus erythematosus."
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) is an emerging
Israeli biopharmaceutical company focused primarily on the
development and acquisition of late clinical-stage, proprietary
formulations and combinations of existing drugs. The Company's
current product pipeline includes: (i) RHB-101 - a
once-daily formulation of a leading congestive heart failure and
high blood pressure drug, with a planned NDA submission in the U.S.
subject to further CMC and PK work, and a planned Marketing
Authorization Application (MAA) in Europe subject to further CMC
work; (ii) RHB-102 - a once-daily formulation of a
leading chemotherapy and radiotherapy-induced nausea and vomiting
prevention drug, planned for U.S. NDA submission in the first
quarter of 2014; (iii) RHB-103 - an oral thin film
formulation of a leading drug for the treatment of acute migraine,
with a U.S. NDA accepted for review by the FDA in June 2013 and a
PDUFA date of February 3, 2014; (iv) RHB-104 - a
combination therapy for the treatment of Crohn's disease, planned
to commence a first Phase III trial in the third quarter of 2013,
multiple sclerosis (MS), with a Phase IIa proof of concept trial
currently underway, rheumatoid arthritis (RA), with plans for a
Phase IIa proof of concept trial, and systemic lupus erythematosus;
(v) RHB-105 - a combination therapy for
Helicobacter pylori infection, planned to commence a phase II/III
trial in the third quarter of 2013, and (vi)
RHB-106 - an encapsulated formulation for bowel
preparation (laxative) ahead of colonoscopy and other GI
procedures. 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 not guarantees of
future performance, are based on certain assumptions and the
Company's current and best understanding of the regulatory status
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 and approvals; (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 under their respective licensing
agreements; (x) estimates of the Company's expenses, future
revenues, capital requirements and the Company's needs for
additional financing; (xi) competitive companies and technologies
within the Company's industry; and (xii) 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 From 20-F filed with the SEC on February 19, 2013,
and its Reports on Form 6-K. Investors and security holders are
urged to read these documents free of charge on the SEC's web site
at http://www.sec.gov. 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 made by us or on our behalf as a result
of new information, future events or other factors.
1 EvaluatePharma - 2013 worldwide sales by indication
CONTACT: PR contact (US):
Lauren Glaser
Vice President
The Trout Group
+1-646-378-2972
lglaser@troutgroup.com
Company contact:
Adi Frish
Senior VP Business Development & Licensing
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
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