- Imeglimin in combination with insulin was observed to
demonstrate consistent and sustained efficacy in the TIMES 3
36-week, open-label extension period
- These results build upon the positive results from the
16-week double-blind, placebo-controlled part of the TIMES 3 trial
announced in June 2019
- Imeglimin in combination with insulin was observed to show a
favorable safety and tolerability profile throughout the 52 weeks
of treatment in TIMES 3
- Phase 3 results from the TIMES 2 trial are anticipated
around the end of 2019
- Imeglimin Japanese New Drug Application (JNDA) targeted for
2020
Poxel will host an investor conference call today to discuss the
results at 1:00 pm EST (7:00 pm CET). To participate in the call,
please use the dial-in numbers: US: +1 646-722-4916 France: +33
172-727-403 UK: +44 207-194-3759 Access Code: 18698372#. For a
replay of the call, please use: US: +1 646-722-4969 FR: +33
170-710-160 UK: +44 203-364-5147 Access Code: 418889018#.
POXEL SA (Euronext – POXEL – FR0012432516), a biopharmaceutical
company focused on the development of innovative treatments for
metabolic disorders, including type 2 diabetes, announced today
positive topline Phase 3 results from the 36-week, open-label
extension period of the TIMES 3 trial, which evaluated Imeglimin in
combination with insulin for the treatment of type 2 diabetes.
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,
Department of Metabolism and Endocrinology, Juntendo University
Graduate School of Medicine, Tokyo, Japan. “Given the efficacy of
Imeglimin observed in this insulin-treated population combined with
the favorable safety and tolerability profile, I believe it has the
potential to provide a new treatment option to help manage glycemic
control in these patients.”
As previously announced, the 16-week, double-blind
placebo-controlled randomized portion of 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 the open-label extension period, which was not
placebo-controlled, 208 Japanese patients who completed the first
16 weeks of the study were administered 1,000 mg Imeglimin orally
twice-daily as well as insulin therapy for the next 36 weeks. The
HbA1c decrease observed at the end of the open-label extension
period was:
- -0.64% versus baseline in patients receiving Imeglimin and
insulin for 52 weeks (Imeglimin and insulin for 16 weeks followed
by Imeglimin and insulin for 36 weeks).
- -0.54% versus baseline in patients receiving Imeglimin and
insulin for the last 36 weeks only (placebo and insulin for 16
weeks followed by Imeglimin and insulin for 36 weeks).
- The results of this study were observed to demonstrate
sustained efficacy of Imeglimin as an add-on therapy to
insulin.
Overall, the safety and tolerability profile of Imeglimin was
observed to be favorable for the entire portion of the 52-week
trial. In the first 16-week double-blind placebo-controlled
treatment period, the incidence of treatment emergent adverse
events was similar to the placebo group. In the 36-week extension
period, the safety and tolerability profile was consistent with the
first part of the trial. There were no episodes of severe
hypoglycemia events and the majority of the hypoglycemia events
reported were mild.
"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. We are very pleased with the
sustained efficacy observed for Imeglimin over a one-year period in
combination with insulin," said Thomas Kuhn, CEO of Poxel. “These
data demonstrate efficacy with a favorable safety and tolerability
profile in a different patient population than the TIMES 1
monotherapy trial and we are looking forward to the TIMES 2 results
evaluating Imeglimin in combination with marketed therapies
available in Japan. We are continuing to work very closely with our
partner, Sumitomo Dainippon Pharma, in preparing for the Japanese
New Drug Application and the TIMES 3 results bring us one step
closer to achieving that goal.”
Poxel anticipates presenting full data results from the Phase 3
TIMES 3 trial at an upcoming scientific meeting.
About the Phase 3 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 is a joint development effort between
Poxel and Sumitomo Dainippon Pharma Co., Ltd. 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 countries1. 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
topline results were 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, glinide,
alpha-glucosidase inhibitor, thiazolidine and GLP1 receptor
agonist. The TIMES 2 topline results are expected around the end of
2019.
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. The
TIMES 3 16-week portion of the trial met its primary endpoint with
a favorable safety and tolerability profile observed and the
topline results were reported on June 25, 2019.
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 pancreas, muscles, and the liver, 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 is a dynamic biopharmaceutical
company that uses its extensive expertise in developing
innovative drugs for metabolic diseases, with a focus on
type 2 diabetes and non-alcoholic steatohepatitis
(NASH). In its mid-to-late stage pipeline, the Company is
currently advancing three drug candidates as well as earlier-stage
opportunities. Imeglimin, Poxel’s first-in-class lead
product, targets mitochondrial dysfunction. Together, with its
partner Sumitomo Dainippon Pharma, Poxel is conducting the Phase 3
Trials of IMeglimin for Efficacy and
Safety (TIMES) program for the treatment of type 2 diabetes
in Japan. Poxel also established a partnership with Roivant
Sciences for Imeglimin’s development and commercialization in
countries outside of the 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 clinical testing and being
developed for the treatment of NASH. Poxel also has additional
earlier-stage programs targeting metabolic, specialty and rare
diseases. The Company intends to generate further growth through
strategic partnerships and pipeline development. Listed on Euronext
Paris, Poxel is headquartered in Lyon, France, and has subsidiaries
in Boston, MA, and Tokyo, Japan. For more information, please
visit: www.poxelpharma.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.
1 including 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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version on businesswire.com: https://www.businesswire.com/news/home/20191125005733/en/
Poxel SA
Jonae R. Barnes Senior Vice President, Investor
Relations and Public Relations jonae.barnes@poxelpharma.com +1 617 818 2985
Aurélie Bozza Investor Relations & Communication Director
aurelie.bozza@poxelpharma.com +33 6 99 81 08 36
Investor relations / Media - EU/US Trophic Communications
Stephanie May or Joanne Tudorica may@trophic.eu or tudorica@trophic.eu +49 89 238 877 34 or +49 171
185 56 82
Investor relations / Media - France NewCap Alexia Faure /
Arthur Rouillé poxel@newcap.eu +33 1
44 71 94 94
Poxel (EU:POXEL)
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