- For strategic reasons, Metavant has decided not to advance
Imeglimin into a Phase 3 program
- Metavant will actively explore options for a potential
out-licensing of Imeglimin rights for a period of 60 days; Metavant
intends to return Imeglimin rights to Poxel if they are unable to
reach an agreement on material terms within this period
- No impact on Sumitomo Dainippon Pharma partnership;
Following successful completion of the Phase 3 program, a New Drug
Application for Imeglimin in Japan (J-NDA) is currently advancing
through regulatory review with a target product launch anticipated
in fiscal year 20211
- Imeglimin is a first-in-class drug candidate with a unique
dual mechanism of action with the potential to treat type 2
diabetes across several stages of the current treatment paradigm,
both as a monotherapy or as an add-on to other glucose lowering
therapies, and could be a treatment option for the sensitive
patient populations, such as those with chronic kidney
disease
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 that Metavant has conducted
a strategic review and has decided not to move forward with the
development of Imeglimin. This decision was not based on any
efficacy, safety or other data generated through the
partnership.
“As a novel first-in-class drug candidate that aims to address
type 2 diabetes across several stages of the current treatment
paradigm, Imeglimin has already successfully completed the Phase 3
TIMES program in Japan under a partnership with Sumitomo Dainippon
Pharma, and it is currently under regulatory review to request
approval for manufacturing and marketing for the treatment of type
2 diabetes in Japan. Based on the outcome of those trials, we see
this compound as a novel and innovative potential therapy that
could benefit patients with type 2 diabetes globally. Today’s
announcement does not impact the agreement for Imeglimin with
Sumitomo Dainippon Pharma. Moving forward, we are preparing to
explore various options to advance Imeglimin into a Phase 3
development program in the US, Europe and other countries currently
covered under the Metavant agreement,” said Thomas Kuhn, CEO of
Poxel. “In addition to advancing our two Phase 2 programs, PXL770
and PXL065, for the treatment of NASH, we remain fully committed to
Imeglimin and our vision of developing innovative drugs for
metabolic diseases.”
“Although we are not planning for continued development of
Imeglimin at this time, we continue to believe that Imeglimin has a
potentially unique profile with a novel mechanism of action, and we
are encouraged by the positive results generated by Metavant and by
Sumitomo Dainippon Pharma in Japan,” said Paul Strumph, MD, Chief
Medical Officer of Metavant.
Metavant will not be entitled to any payment from Poxel in the
event that rights to Imeglimin are returned to Poxel. Poxel
anticipates no impact to its projected cash runway and that its
cash and cash equivalents will continue to be sufficient to fund
operations through 2022 based on its current business plan. As of
September 30, 2020, Poxel had cash and cash equivalents of EUR 41.5
million (USD 48.6 million).
About Imeglimin
Imeglimin is a new chemical substance classified as a
tetrahydrotriazine compound, and the first clinical candidate in a
chemical class. Imeglimin has a unique dual 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 and Sumitomo Dainippon Pharma Strategic
Partnership
Poxel and Sumitomo Dainipppon Pharma have a strategic
partnership for the development and commercialization of Imeglimin
in Japan, China, South Korea, Taiwan and nine other Southeast Asian
countries.2 The Imeglimin Phase 3 TIMES program was successfully
completed in December 2019. On July 30, 2020, Poxel announced that
Sumitomo Dainippon Pharma submitted a J-NDA to the Pharmaceuticals
and Medical Devices Agency (PMDA) to request approval for
manufacturing and marketing of Imeglimin for the treatment of type
2 diabetes. The Imeglimin J-NDA is supported by numerous
preclinical and clinical trials, including the Phase 3 TIMES
(Trials of IMeglimin for Efficacy and
Safety) program in Japan. The TIMES program was a joint
development effort between Poxel and Sumitomo Dainippon Pharma Co.,
Ltd. and it included three pivotal trials to evaluate Imeglimin’s
efficacy and safety in over 1,100 patients. In all three trials,
Imeglimin met its primary endpoints and objectives and was observed
to exhibit a favorable safety and tolerability profile.
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. 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. 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
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.
2 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/20201119006403/en/
Poxel SA Jonae R. Barnes Senior Vice President, Investor
Relations, Corporate Communications 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 Valeria Fisher may@trophic.eu or fisher@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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