- Imeglimin in combination with insulin Phase 3 TIMES 3
16-week, double-blind, placebo-controlled, randomized part of the
trial met its primary endpoint with a favorable safety and
tolerability profile
- TIMES 3 16-week data is the second positive readout from the
three pivotal trials of the TIMES program in Japan
- Phase 3 results from the TIMES 2 and 36-week open-label
extension part of TIMES 3 are anticipated around the end of
2019
- Imeglimin Japanese New Drug Application (JNDA) targeted for
2020
- The Japanese diabetes market is fast-growing and anticipated
to reach approximately $6B by 20201
POXEL SA (Euronext – POXEL - FR0012432516), a biopharmaceutical
company focused on the development of innovative treatments for
metabolic disorders, including type 2 diabetes and non-alcoholic
steatohepatitis (NASH) and Sumitomo Dainippon Pharma Co., Ltd (Head
Office: Osaka, Japan; Representative Director, President and CEO:
Hiroshi Nomura; Securities Code: 4506, First Section of TSE),
announced today positive top-line Phase 3 data results for the
Imeglimin TIMES 3 16-week, double-blind, placebo-controlled,
randomized part of the trial for the treatment of 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 over 1,100 patients.
“I am very excited to contribute to the development of a new and
innovative potential treatment option for Japanese patients with
type 2 diabetes,” said Professor Hirotaka Watada, MD, PhD,
Professor, Department of Medicine, Metabolism and Endocrinology,
Juntendo University Graduate School of Medicine, Tokyo, Japan.
“Imeglimin’s safety profile combined with its unique mechanism of
action that targets very important deficiencies occurring in
diabetes, could be helpful for Japanese patients treated with
insulin to further manage their advanced disease.”
The TIMES 3 16-week, double-blind, placebo-controlled,
randomized part of the trial evaluated efficacy and safety of
Imeglimin in 215 patients. In this trial, Imeglimin 1,000 mg was
orally administered twice-daily in combination with insulin in
Japanese patients with type 2 diabetes and inadequate glycemic
control on insulin therapy versus patients administered placebo and
insulin. The TIMES 3 trial was observed to demonstrate efficacy and
achieved statistical significance (p<0.0001) for its primary
endpoint, defined as a change of glycated hemoglobin A1c (HbA1c)
from baseline versus placebo at week 16, with a mean HbA1c
placebo-corrected change from baseline of -0.60%.
In this trial, the overall safety and tolerability of Imeglimin
was similar to placebo. A similar number of patients experienced
hypoglycemia with Imeglimin compared to the placebo group with a
fixed insulin daily dose as defined in the protocol. There were no
severe hypoglycemia events and the majority of the hypoglycemia
events reported were mild. In addition, the adverse event profile
was similar to placebo and consistent with what was observed in the
Phase 3 TIMES 1 monotherapy trial and other Imeglimin clinical
trials. Additional analyses of the trial, including secondary
endpoints, is ongoing and the results of the 36-week open-label
extension part of TIMES 3 are anticipated around the end of
2019.
"Despite efforts to manage type 2 diabetes with diet and oral
agents, many patients transition to insulin therapy as a natural
part of the disease progression. For patients with type 2 diabetes
who are inadequately controlled on insulin alone, TIMES 3 data show
that Imeglimin has the potential to be a new treatment option that
could significantly reduce HbA1c with a favorable safety and
tolerability profile," said Christophe Arbet-Engels, MD, PhD, Chief
Medical Officer, Executive Vice President Late Development and
Medical Affairs at Poxel. “The TIMES 3 16-week results are the
second positive readout from the three pivotal trials in the TIMES
program and follow the positive TIMES 1 monotherapy results
announced in April 2019. We are working very closely with our
partner Sumitomo Dainippon Pharma in preparing for the Japanese New
Drug Application and these results bring us one step closer to
achieving that goal.”
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
“Our commitment to diabetes patients is to continue to innovate
and provide new therapeutic options to help them manage their
disease. We are very pleased with the positive results for TIMES 1
and the TIMES 3 16-week part of the trial, and to be working
closely with Poxel on the TIMES clinical trials,” said Nobuhiko
Tamura, Member, Board of Directors, Senior Executive Officer; Drug
Development Division of Sumitomo Dainippon Pharma. “Diabetes is a
significant area for our company in Japan and we believe that
Imeglimin will be a very important addition to our existing
diabetes franchise.”
Poxel anticipates presenting full data results from the Phase 3
TIMES 3 16-week portion of the trial at an upcoming scientific
meeting.
Poxel will host a conference call to discuss the results later
today. To access the information please click this link or refer to
Poxel’s website.
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 over 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 trial 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 include fasting plasma
glucose, other standard glycemic and non-glycemic parameters. The
TIMES 1 trial met its primary and secondary endpoints and the
top-line data was reported on April 9, 2019.
TIMES 2: A Phase 3, 52-week, open-label, parallel-group
trial to assess the long-term safety and efficacy of Imeglimin in
Japanese patients with type 2 diabetes. In this trial, 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 trial 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. PXL770, a first in class direct adenosine
monophosphate-activated protein kinase (AMPK) activator, is in a
Phase 2a proof-of-concept program for the treatment of NASH. PXL770
could also have the potential to treat additional metabolic
diseases. PXL065 (deuterium-stabilized R-pioglitazone), a
mitochondrial pyruvate carrier (MPC) inhibitor, is in Phase 1 and
being developed for the treatment of NASH. Poxel also has
additional earlier-stage programs, including deuterated drug
candidates for metabolic, specialty and rare diseases. We intend to
generate further growth through strategic partnerships and pipeline
development. (Euronext: POXEL, www.poxelpharma.com)
About Sumitomo Dainippon Pharma
Sumitomo Dainippon
Pharma defines its corporate mission as "to broadly contribute to
society through value creation based on innovative research and
development activities for the betterment of healthcare and fuller
lives of people worldwide". By pouring all our efforts into the
research and development of new drugs, we aim to provide innovative
and effective pharmaceutical solutions to people not only in Japan
but also around the world in order to realize our corporate
mission. Sumitomo Dainippon Pharma aims to create innovative
pharmaceutical products in the Psychiatry & Neurology area, the
Oncology area and Regenerative Medicine & Cell Therapy, which
have been designated as the focus research areas. Sumitomo
Dainippon Pharma has also positioned Psychiatry & Neurology,
Diabetes and Specialty as our focus marketing areas in Japan. For
more detail, please visit our website.
(https://www.ds-pharma.com/)
All statements other than statements of historical fact included
in this press release about future events are subject to (i) change
without notice and (ii) factors beyond the Company’s control. These
statements may include, without limitation, any statements preceded
by, followed by or including words such as “target,” “believe,”
“expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,”
“project,” “will,” “can have,” “likely,” “should,” “would,” “could”
and other words and terms of similar meaning or the negative
thereof. Forward-looking statements are subject to inherent risks
and uncertainties beyond the Company’s control that could cause the
Company’s actual results or performance to be materially different
from the expected results or performance expressed or implied by
such forward-looking statements.
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.
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Poxel SA Jonae R. Barnes Senior Vice President, Investor
Relations and Public Relations jonae.barnes@poxelpharma.com +1 617
818 2985
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Sumitomo Dainippon Pharma Co., Ltd. Corporate
Communications Tel: +81-6-6203-1407 (Osaka); +81-3-5159-3300
(Tokyo)