- Subject to a successful
outcome and any additional regulatory feedback,
the confirmatory Phase III
study (ERADICATE Hp 2) is
expected to complete the package required for a potential U.S. NDA
for RHB-105, newly branded as TALICIA(TM)
- The two-arm, randomized,
double-blind, active comparator, confirmatory Phase III 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., with a primary endpoint of
eradication of H. pyloriinfection at 42
through 70 days after initiation of
treatment
- The first Phase III study
with TALICIA(TM) (RHB-105)
(ERADICATE Hp) successfully demonstrated 89.4% efficacy in
eradicating H. pylori infection
(p<0.001), supporting the potential superior efficacy of
TALICIA(TM) (RHB-105)
over current standard-of-care (SoC)
therapies
- TALICIA(TM) (RHB-105)
was granted QIDP designation by the FDA under the GAIN Act,
including Fast-Track development, NDA Priority Review and extended
U.S. market exclusivity, for a total of eight
years
- H.
pylori bacterial infection
is a major cause of chronic gastritis, peptic ulcer disease,
gastric cancer and mucosa-associated lymphoid tissue (MALT)
lymphoma and is estimated to affect over half of the adult
population worldwide
- 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 in group 2 high-priority bacteria for which new
treatments are urgently needed
- The 2015 global and U.S.
market potential for H.
pylori eradication therapies at current branded prices,
were estimated at approximately $4.83 billion and $1.45 billion,
respectively
TEL-AVIV, Israel and RALEIGH,
N.C., June 15, 2017 (GLOBE NEWSWIRE) -- 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(TM)1, for the
treatment of H. pylori infection
(the ERADICATE Hp 2 study).
TALICIA(TM) (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(TM) (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(TM) (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. pyloriinfection 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(TM) (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(TM) (RHB-105).
The first Phase III study with
TALICIA(TM) (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(TM) (RHB-105).
Notably, the 89.4% efficacy in eradicating H. pylori infection with TALICIA(TM)(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(TM) (RHB-105)
as a treatment forH. pylori infection.
Treatment with TALICIA(TM) (RHB-105)
appeared to be safe and well tolerated.
TALICIA(TM) (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(TM) (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(TM) (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(TM) (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(TM) (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(TM) (RHB-105):
RHB-105, newly branded as TALICIA(TM), 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(TM) (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(TM) (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(TM) (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(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) 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(TM) 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
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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