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Poxel Announces Completion of Patient Enrollment for TIMES 2 Trial in Phase 3 Registration Program for Imeglimin, an Investigational Therapeutic Agent for Type 2 Diabetes, in Japan

POXEL
SA (Euronext a?? POXEL - FR0012432516), a biopharmaceutical company
focused on the development of innovative treatments for metabolic
diseases, including type 2 diabetes and non-alcoholic steatohepatitis
(NASH), announced today that patient enrollment has been completed in
the TIMES 2 trial of the Phase 3 registration program for Imeglimin, an
investigational therapeutic agent for type 2 diabetes, in Japan.
Referred to as TIMES (Trials ofA IMeglimin forA Efficacy
andA Safety), the Imeglimin Phase 3 registration program in
Japan includes three pivotal trials to evaluate the efficacy and safety
of Imeglimin in over 1,100 patients. The TIMES 2 trial is a 52-week,
open-label, parallel-group study to assess the long-term safety and
efficacy of Imeglimin in Japanese patients with type 2 diabetes. In this
trial, Imeglimin is administrated as a monotherapy or combination
therapy to over 700 patients with existing hypoglycemic agents,
including a DPP4 inhibitor, SGLT2 inhibitor, biguanide, sulphonylurea
and GLP1 receptor agonist.


"In less than one year after signing the strategic partnership with
Sumitomo Dainippon Pharma, we have made substantial progress advancing
all three pivotal Phase 3 TIMES trials for Imeglimin in Japan. This
achievement is a direct result of our close collaboration with Sumitomo
Dainippon Pharma. We remain on track for the TIMES 1 data results in the
second quarter of 2019 and the TIMES 2 and TIMES 3 data results are
anticipated in the second half of 2019,a?? said Thomas Kuhn, CEO of Poxel.
"In addition to advancing the Imeglimin Phase 3 program in Japan, we
have recently established a subsidiary and expanded our team with the
appointment of Takashi Kaneko, MD, PhD, as Senior Vice President Medical
and President of Poxel Japan K.K.a??


"I am very pleased to report that the execution of the TIMES program,
which is being led by Poxel, has continued to progress in a very timely
manner and we have now completed enrollment of all three Phase 3 pivotal
studies, which includes over 1,100 patients,a?? said Christophe
Arbet-Engels, MD, PhD, Chief Medical Officer, Executive Vice President,
Late Development and Medical Affairs of Poxel. "We are committed to the
successful completion of the TIMES program and will continue to closely
collaborate with our colleagues at Sumitomo Dainippon Pharma to support
the Japanese New Drug Application submission anticipated in 2020. Our
near-term goal in Japan is to provide patients with a new, innovative
therapeutic option for type 2 diabetes.a??


The TIMES program is a joint development effort between Poxel and
Sumitomo Dainippon Pharma. The companies entered into a strategic
partnership in October 2017 for the development and commercialization of
Imeglimin in Japan, China, South Korea, Taiwan and nine other Southeast
and East Asian countries.2
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