Market Overview

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

Share:
  • Phase 3 TIMES data readout is on track for 2019
  • Japanese New Drug Application submission for Imeglimin targeted in
    2020
  • Diabetes is a fast-growing market in Asia and Japan is the second
    largest single market for type 2 diabetes outside of the U.S.; it is
    expected to grow to approximately $6 billion in 2020
    1

POXEL
SA
(Euronext – 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 3 trial of the Phase 3 registration program for Imeglimin, an
investigational therapeutic agent for type 2 diabetes, in Japan.
Referred to as TIMES (Trials of IMeglimin for Efficacy
and Safety), the Imeglimin Phase 3 registration program in
Japan includes three pivotal trials to evaluate the efficacy and safety
of Imeglimin in approximately 1,100 patients. The TIMES 3 trial is a
double-blind, placebo-controlled, randomized study with an open-label
extension period to evaluate the efficacy and safety of Imeglimin in
combination with insulin in over 200 Japanese patients with type 2
diabetes and inadequate glycemic control on insulin therapy.

"We continue to make progress advancing all three pivotal Phase 3 TIMES
trials for Imeglimin in Japan. We have completed patient enrollment for
the TIMES 1 and TIMES 3 trials, and we are on track for the TIMES 1 data
readout in the second quarter of 2019 and the TIMES 2 and TIMES 3 data
readouts in the second half of 2019," said Thomas Kuhn, CEO of Poxel.
"Enrollment of the TIMES 2 trial is anticipated to be completed during
the second half of 2018. Our near-term focus in Japan is the successful
execution of TIMES, and, to this end, we are working closely with our
colleagues at Sumitomo Dainippon Pharma to support the Japanese New Drug
Application submission anticipated in 2020."

"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," said Christophe Arbet-Engels, MD, PhD, Chief Medical Officer,
Executive Vice President, Late Development and Medical Affairs of Poxel.
"The completion of patient enrollment for the TIMES 3 study is one
additional step that brings us potentially closer to providing a new and
differentiated therapeutic option for Japanese patients with type 2
diabetes."

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
Asian countries.2

Imeglimin is an orally-available drug candidate with a novel mechanism
of action that has been observed in clinical studies to demonstrate
glucose lowering benefits by simultaneously targeting all three key
organs, which play an important role in the treatment of type 2
diabetes, the liver, muscles and the pancreas. Imeglimin has
demonstrated in preclinical studies the potential to address
mitochondrial dysfunction, which is believed to be at the core of type 2
diabetes pathophysiology. Imeglimin has completed Phase 1 and Phase 2
development in over 1,200 subjects in the U.S., Europe and Japan.

About the TIMES Program
TIMES (Trials of Imeglimin
for Efficacy and Safety), the Phase 3 program
for Imeglimin for the treatment of type 2 diabetes in Japan, consists of
three pivotal trials involving approximately 1,100 patients. The TIMES
program includes the following three trials that will be performed using
the dose of 1,000 mg twice daily:

TIMES 1: A Phase 3, 24-week, double-blind placebo-controlled,
randomized, monotherapy study to assess the efficacy, safety and
tolerability of Imeglimin in Japanese patients with type 2 diabetes,
using the change in HbA1c as the primary endpoint. Secondary endpoints
of the trial will include other standard glycemic and non-glycemic
parameters.

TIMES 2: A Phase 3, 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 study, Imeglimin will be administrated orally
as a monotherapy or combination therapy with existing hypoglycemic
agents, including a DPP4 inhibitor, SGLT2 inhibitor, biguanide,
sulphonylurea and GLP1 receptor agonist.

TIMES 3: A Phase 3, 16-week, double-blind, placebo-controlled,
randomized study with a 36-week open-label extension period to evaluate
the efficacy and safety of Imeglimin in combination with insulin in
Japanese patients with type 2 diabetes and inadequate glycemic control
on insulin therapy.

About Imeglimin
Imeglimin is the first clinical candidate in
a new chemical class of oral agents called Glimins by the World Health
Organization. Imeglimin has a unique mechanism of action ("MOA") that
targets mitochondrial bioenergetics. Imeglimin acts on all three key
organs which play an important role in the treatment of type 2 diabetes:
the liver, muscles and the pancreas, and it has demonstrated glucose
lowering benefits by increasing insulin secretion in response to
glucose, improving insulin sensitivity and suppressing gluconeogenesis.
This MOA has the potential to prevent endothelial and diastolic
dysfunction, which can provide protective effects on micro- and
macro-vascular defects induced by diabetes. It also has the potential
for protective effect on beta-cell survival and function. This unique
MOA offers the potential opportunity for Imeglimin to be a candidate for
the treatment of type 2 diabetes in almost all stages of the current
anti-diabetic treatment paradigm, including monotherapy or as an add-on
to other glucose lowering therapies.

About Poxel SA
Poxel uses its development expertise in
metabolism to advance a pipeline of drug candidates focused on the
treatment of metabolic disorders, including type 2 diabetes and
non-alcoholic steatohepatitis (NASH). We have successfully completed the
Phase 2 clinical program for our first-in-class lead product, Imeglimin,
which targets mitochondrial dysfunction, in the U.S., Europe and Japan.
Together, with our partner Sumitomo Dainippon Pharma, we are conducting
the Phase 3 Trials of IMeglimin for Efficacy
and Safety (TIMES) program for the treatment of type 2
diabetes in Japan. Our partner Roivant Sciences
is responsible for Imeglimin's development and commercialization in
countries outside of Poxel's partnership with Sumitomo Dainippon Pharma,
including the U.S. and Europe. Our second program, PXL770, a first in
class direct adenosine monophosphate-activated protein kinase (AMPK)
activator, is advancing into a Phase 2a proof-of-concept program for the
treatment of NASH. PXL770 could also have the potential to treat
additional metabolic diseases. We intend to generate further growth
through strategic partnerships and pipeline development. (Euronext:
POXEL, www.poxelpharma.com)

1Source: Oppenheimer & Co. estimates.

2including: Indonesia, Vietnam, Thailand, Malaysia, The
Philippines, Singapore, Republic of the Union of Myanmar, Kingdom of
Cambodia and Lao People's Democratic Republic.

View Comments and Join the Discussion!