·
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™
·
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. pylori infection at 42 through 70 days after initiation
of treatment
·
The first Phase III study with TALICIA™ (RHB-105)
(ERADICATE Hp) successfully demonstrated 89.4% efficacy in eradicating H.
pylori infection (p<0.001), supporting the potential superior
efficacy of TALICIA™ (RHB-105) over current standard-of-care
(SoC) therapies
·
TALICIA™ (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 16 (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™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.
