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 the initiation of a confirmatory Phase III study
with RHB-105, newly branded as TALICIA™1, for the treatment of H.
pylori infection (the ERADICATE Hp 2 study).
TALICIA™ (RHB-105) is a proprietary, fixed-dose,
oral combination therapy of two antibiotics and a proton pump
inhibitor (PPI) in an all-in-one oral capsule for the eradication
of H. pylori infection.
The two-arm, randomized, double-blind, active
comparator confirmatory Phase III ERADICATE Hp 2 study will compare
TALICIA™ (RHB-105) against a dual therapy amoxicillin and
omeprazole regimen at equivalent doses. The study is planned to
enroll 444 non-investigated dyspepsia patients with
confirmed H. pylori infection in up to 65 clinical sites
in the U.S. Subjects will be randomized in a 1:1 ratio to receive
four capsules, three times daily, of either TALICIA™ (RHB-105) or
the active comparator, for a period of 14 days. Subjects will be
assessed for the study’s primary endpoint of eradication of H.
pylori infection at 42 through 70 days after initiation of
treatment.
Subject to its successful outcome and any
additional regulatory feedback, the confirmatory Phase III study,
along with the results from the successfully completed first Phase
III study with TALICIA™ (RHB-105) (the ERADICATE Hp study) and data
from the completed supportive PK program, are expected to support a
potential U.S. New Drug Application (NDA) for TALICIA™
(RHB-105).
The first Phase III study with TALICIA™
(RHB-105) successfully met its protocol-defined mITT primary
endpoint of superiority over historical standard-of-care (SoC)
eradication rate of 70%, with high statistical significance
(p<0.001). The study results demonstrated 89.4% efficacy in
eradicating H. pylori infection with TALICIA™ (RHB-105).
Notably, the 89.4% efficacy in eradicating H. pylori infection
with TALICIA™ (RHB-105) was also superior to subsequent open-label
treatment with SoC therapies of patients in the placebo arm of the
ERADICATE Hp study, which demonstrated 63% eradication rate in the
mITT population (p=0.006), further supporting the potential
efficacy of TALICIA™ (RHB-105) as a treatment for H.
pylori infection. Treatment with TALICIA™ (RHB-105) appeared
to be safe and well tolerated.
TALICIA™ (RHB-105) was granted Qualifying
Infectious Disease Product (QIDP) designation by the U.S. Food and
Drug Administration (FDA), providing a Fast-Track development
pathway, as well as NDA Priority Review status, potentially leading
to a shorter NDA review time by the FDA, if filed. If approved,
TALICIA™ (RHB-105) is entitled to receive, thanks to its QIDP
status, an additional five years of U.S. market exclusivity, in
addition to the standard exclusivity period, for a total of 8 years
of U.S. market exclusivity.
RedHill is pursuing with TALICIA™ (RHB-105) an
indication of first-line treatment of H. pylori infection,
regardless of ulcer status, a significantly broader indication than
current standard treatments for H. pylori, which are
typically indicated only for patients with active or recent history
of duodenal ulcer disease. If approved, TALICIA™ (RHB-105) may be
the first H. pylori eradication therapy in the U.S. to
target this broader indication, which would significantly expand
the potential patient population for this drug candidate.
H. pylori bacterial infection is a major
cause of chronic gastritis, peptic ulcer disease, gastric cancer
and mucosa-associated lymphoid tissue (MALT) lymphoma. H. pylori
infection is estimated to affect over half of the adult population
worldwide2. The growing resistance of the H. pylori bacteria to
metronidazole and clarithromycin has resulted in increasing failure
rates of current SoC for H. pylori eradication, reaching an
estimated 30%3. Despite the strong unmet medical need, no new drug
has been approved by the FDA for this indication in over a decade.
The World Health Organization (WHO) recently published a global
priority list of 12 life-threatening multidrug-resistant bacteria,
in which H. pylori infection was classified as a high-priority
bacteria for which new treatments are urgently needed4.
The 2015 global and U.S. market potential
for H. pylori eradication therapies at branded prices,
were estimated at approximately $4.83 billion and $1.45 billion,
respectively, and could potentially grow with increasing awareness
of the health risks associated with H. pylori infection
and the benefits of its eradication5.
The confirmatory Phase III ERADICATE Hp 2 study
with TALICIA™ (RHB-105) will be 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 TALICIA™
(RHB-105):RHB-105, newly branded as TALICIA™, is a new and
proprietary fixed-dose oral combination therapy of two antibiotics
and a proton pump inhibitor (PPI) in an all-in-one oral capsule
with a planned indication for the treatment of H.
pylori infection. H. pylori bacterial infection is a
major cause of chronic gastritis, peptic ulcer disease, gastric
cancer and mucosa-associated lymphoid tissue (MALT) lymphoma. A
first Phase III study with TALICIA™ (RHB-105) (the ERADICATE Hp
study) was completed in the U.S. with positive results. The study
demonstrated an overall success rate of 89.4% in eradicating H.
pylori, and met its protocol-defined primary endpoint of
superiority in eradication of H. pylori infection over
historical standard-of-care efficacy levels of 70%, with high
statistical significance (p<0.001). A confirmatory Phase III
study (ERADICATE Hp 2 study) has been initiated in the U.S.
Additional studies may be required, subject to FDA review. TALICIA™
(RHB-105) has been granted Qualifying Infectious Disease Product
(QIDP) designation by the FDA, providing a Fast-Track development
pathway, as well as NDA Priority Review status, potentially leading
to a shorter NDA review time by the FDA, if filed. If approved,
TALICIA™ (RHB-105) will also receive an additional five years of
exclusivity, in addition to the standard exclusivity period, for a
total of 8 years of U.S. market exclusivity.
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™ (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) 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.
_____________________________
1 TALICIA™ is an investigational new drug, not available
for commercial distribution.
2 Hunt, R. H., et al. "Helicobacter pylori in developing
countries." World Gastroenterology Organisation Global Guidelines
(2010): 1-15.
3 Malfertheiner P. et al. Management of Helicobacter
pylori infection - the Maastricht IV/ Florence Consensus
Report, Gut 2012;61:646-664.
4 WHO report - Global priority list of antibiotic-resistant
bacteria to guide research, discovery, and development of new
antibiotics:
http://www.who.int/medicines/publications/global-priority-list-antibiotic-resistant-bacteria/en/
5 Jerry Rosenblatt, Ph.D., a member of RedHill’s Advisory
Board and Partner at Foster Rosenblatt, RedHill
Biopharma press release: RedHill Biopharma’s Investor
Webcast Forum Provides Update on the RHB-105 Phase III
Program and Potential H. Pylori Eradication Market,
May 18, 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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