Poxel Presents New Results of Imeglimin Phase 2 & 3 Clinical Studies in Japan at the 64th Annual Meeting of the Japan Diabete...
May 20 2021 - 12:35PM
Business Wire
- Kaku et al. Long-term efficacy and safety in Phase 3 study
with Imeglimin as mono- and add-on therapy in Japanese T2DM
patients: results from TIMES 2 trial
- Hata et al. Post hoc analysis of Phase 2 and 3 studies of
Imeglimin – similar efficacy and consistent safety in patients with
different backgrounds, including elderly patients and those with
renal impairment
- Kondo et al. Post hoc analyses of Phase 2 and 3 studies of
Imeglimin – similar efficacy in patients with impaired insulin
secretion or impaired insulin sensitivity
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), today announced presentations of new
results from Imeglimin Phase 2 and 3 clinical studies at the 64th
Annual Meeting of the Japan Diabetes Society, which is being held
virtually (May 20-22, 2021).
Imeglimin is a novel agent that acts on both key defects in type
2 diabetes (T2DM) by improving insulin secretion in response to
glucose and insulin sensitivity through a unique mode of action.
These new results (summarized below) were obtained and presented by
Poxel’s clinical development team in collaboration with its
partner, Sumitomo Dainippon Pharma and leading diabetologists in
Japan.
- TIMES 2 : Long-term efficacy and safety in Phase 3 study
with Imeglimin as a mono- and add-on therapies in Japanese T2DM:
results from TIMES 2 trial
- Open-label, non-placebo controlled, multicenter study to assess
the long-term safety/efficacy of Imeglimin for 52 weeks as a mono-
and add-on to other available individual antidiabetic therapies in
Japanese T2DM patients
- Adverse events were generally mild and consistent with known
safety/tolerability profile; there was no severe hypoglycemia
- Changes from baseline in HbA1c ranged from -0.56 ± 0.08 to
-0.92 ± 0.11% in patients receiving Imeglimin added to other oral
antidiabetics
- Post hoc analysis of Phase 2 and 3 studies of Imeglimin –
efficacy and safety in patients with different backgrounds,
including elderly patients and those with renal impairment
- Further analysis of data derived from key subgroups - based on
age, renal function or body mass index (BMI) - from the completed
Japanese Phase 2b and TIMES1 Phase 3 trial
- Imeglimin treatment produced similar efficacy (HbA1c reduction)
regardless of age, renal function, and BMI; the safety profile was
also consistent in each subgroup and in comparison with the broader
population
- Post hoc analyses of Phase 2 and 3 studies of Imeglimin –
efficacy in patients with impaired insulin secretion or impaired
insulin sensitivity
- Further analysis of data derived from the completed Japanese
Phase 2b, TIMES 1 and TIMES 2 Phase 3 trials
- Subpopulations of patients with greater or lesser degrees of
insulin resistance and impaired insulin secretion were identified
using standard indices (the value of HOMA-IR, QUICKI and HOMA-β at
baseline, respectively or combination of these indices)
- The effect of Imeglimin to decrease HbA1c was similar in
patient subgroups with predominant insulin resistance or impaired
insulin secretion
“In TIMES 2, which was the largest of our pivotal Phase 3
trials, we found that Imeglimin produced clinically meaningful and
sustained reductions in HbA1c both as a monotherapy and when added
to other commonly used antidiabetics” said Pascale Fouqueray,
Executive Vice President of Clinical Development and Regulatory
Affairs at Poxel. “Consistent with Imeglimin’s dual mechanism of
action, it was also important to confirm that Imeglimin could
perform well across the spectrum of pathophysiologic defects in
insulin action and secretion. We are also very pleased that
Imeglimin appears similarly safe and effective in subgroups with
greater unmet medical need – in particular elderly patients and
those with modest degrees of reduced renal function.”
Imeglimin will be also discussed in Symposium 21 “New therapies
utilizing metformin and concomitant use of new drugs,” on May
22.
“We are proud of our work in Japan and we are especially pleased
by our strong partnership with Sumitomo Dainippon Pharma, the
leading pharmaceutical company in Japan when it comes to delivering
solutions to patients with diabetes,” commented Thomas Kuhn, CEO of
Poxel. “We look forward to the completion of the J-NDA review of
Imeglimin and based on a typical 12-month review by the PMDA, we
believe Imeglimin could be approved in mid-2021 with an anticipated
product launch by our partner Sumitomo Dainippon Pharma in Fiscal
Year 20211.”
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), and selected rare
inherited disorders including adrenoleukodystrophy. In its
mid-to-late-stage pipeline, the Company is currently advancing
three drug candidates; several earlier-stage opportunities are also
underway. Imeglimin, Poxel’s first-in-class lead product,
targets mitochondrial dysfunction. Poxel has a strategic
partnership with Sumitomo Dainippon Pharma for Imeglimin in Japan,
China, South Korea, Taiwan and nine other Southeast Asian
countries. A Japanese new drug application (J-NDA) is under review
by the Pharmaceuticals and Medical Devices Agency (PMDA) to request
approval for the manufacturing and marketing of Imeglimin for the
treatment of type 2 diabetes. After successfully completing a Phase
2a proof-of-concept trial for the treatment of NASH, which met its
primary endpoint and study objectives, for PXL770, a
first-in-class direct adenosine monophosphate-activated protein
kinase (AMPK) activator, Poxel plans to initiate a Phase 2b program
in the second half of 2021. PXL770 could also have the potential to
treat additional metabolic diseases. PXL065
(deuterium-stabilized R-pioglitazone), a MPC inhibitor, is in a
streamlined Phase 2 trial for the treatment of NASH. Poxel also has
additional earlier-stage programs from its AMPK activator and
deuterated TZD platforms targeting chronic and rare metabolic
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
In the context of the COVID-19 outbreak, which was declared a
pandemic by the World Health Organization (WHO) on March 12, 2020,
the Company is regularly reviewing the impact of the outbreak on
its business.
As of the date of this press release, and based on publicly
available information, the Company has not identified the
occurrence of any material negative effect on its business due to
the COVID-19 pandemic that remains unresolved. However, the Company
anticipates that the COVID-19 pandemic could have further material
negative impact on its business operations. The worldwide impact of
COVID-19 may notably affect the Company’s internal organization and
efficiency, particularly in countries where it operates and where
confinement measures are implemented by the authorities. In
addition, COVID-19 may impact market conditions and the Company’s
ability to seek additional funding or enter into partnerships.
Particularly, delays in the supply of drug substance or drug
products, in the initiation or the timing of results of preclinical
and/or clinical trials, as well as delays linked to the
responsiveness of regulatory authorities could occur, which could
potentially have an impact on the Company’s development programs
and partnered programs. The Company will continue to actively
monitor the situation.
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 Year noted is Fiscal Year from April 2021 to March 2022, which
is Sumitomo Dainippon Pharma’s Fiscal Year.
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Poxel SA Catherine David Investor Relations &
Communication Manager catherine.david@poxelpharma.com +33 7 64 57
61 78
Investor relations / Media - EU/US Trophic Communications
Stephanie May or Valeria Fisher poxel@trophic.eu +49 171 185 56 82
or +49 175 804 1816
Investor relations / Media - France NewCap Emmanuel Huynh
or Arthur Rouillé poxel@newcap.eu +33 1 44 71 94 94
Poxel (EU:POXEL)
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