Poxel Announces Initiation of TIMES 2 and TIMES 3 Trials for the Phase 3 Program for Imeglimin, an Investigational Therapeutic Agent for Type 2 Diabetes, in Japan

  • Imeglimin Phase 3 TIMES 1, TIMES 2 and TIMES 3 trials are underway
    in Japan
  • Japanese New Drug Application submission for Imeglimin targeted in
  • 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

(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 the initiation of the TIMES 2 and TIMES 3 trials
for the Phase 3 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 program in Japan includes three pivotal trials to
evaluate Imeglimin’s efficacy and safety in approximately 1,100 patients.

“Over the last few months, we have made significant progress advancing
the TIMES program for Imeglimin in Japan with the initiation of all
three pivotal Phase 3 trials. We are on track for the Phase 3 data
readout in 2019,” said Thomas Kuhn, CEO of Poxel. “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

The TIMES program is a joint development effort between Poxel and
Sumitomo Dainippon Pharma. The companies announced on October 30, 2017,
a strategic partnership for the development and commercialization of
Imeglimin in Japan, China, South Korea, Taiwan and nine other Southeast
Asian countries.2 Through this partnership, the TIMES 1 trial
in Japan was initiated in December 2017.

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., EU 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

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., EU and Japan.
Together, with our partner Sumitomo Dainippon Pharma, we are conducting
the Phase 3 TIMES program for the treatment of type 2 diabetes in Japan.
Our partner Roivant Sciences will be 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 in
Phase 1 and we plan on developing it for the treatment of NASH. We
intend to generate further growth through strategic partnerships and
pipeline development. (Euronext: POXEL, www.poxelpharma.com)

1Source: Oppenheimer & Co. estimates.
Indonesia, Vietnam, Thailand, Malaysia, The Philippines, Singapore,
Republic of the Union of Myanmar, Kingdom of Cambodia and Lao People’s
Democratic Republic.


Poxel SA
Jonae R. Barnes, +1 617-818-2985
Vice President, Investor Relations and Public Relations
relations / Media – EU/US

Trophic Communications
Schweitzer, +49 89 238 877 34
Stephanie May, +49 171 185 56
relations / Media – France

Florent Alba/Nicolas
Merigeau, +33 1 44 71 98 55