- Safety and tolerability profile observed, consistent with
prior clinical studies in the general type 2 diabetes
population
- Based on the results, Sumitomo Pharma is planning to conduct
discussions with the regulatory authorities in Japan, on revising
TWYMEEG® package insert in fiscal 2024 for patients with renal
impairment with eGFR less than 45 mL/min/1.73m2
Regulatory News:
Sumitomo Pharma Co., Ltd. (Head
Office: Osaka, Japan; Representative Director, President and CEO:
Toru Kimura) and POXEL SA (Euronext :
POXEL - FR0012432516), a clinical stage biopharmaceutical company
developing innovative treatments for chronic serious diseases with
metabolic pathophysiology, including non-alcoholic steatohepatitis
(NASH) and rare metabolic disorders, announced today topline
results obtained from a post-marketing clinical study, TWINKLE
(TWYMEEG® in diabetic patients with renal impairment: A post-marketing long-term
study) (“the Study”), in Japanese type 2 diabetic patients
with renal impairment for TWYMEEG® Tablets 500 mg (generic name:
imeglimin hydrochloride, “the Drug”) being sold in Japan,
based on the Risk Management Plan.
The Study was an open-label, uncontrolled, long-term study in 60
Japanese type 2 diabetic patients with renal impairment, who had no
experience of type 2 diabetes treatment other than diet and
exercise therapy or insufficient glycemic management in monotherapy
with a hypoglycemic agent excluding insulin formulation.
The Drug was administered at 500 mg twice-daily to patients with
moderate and severe renal impairment, characterized by an estimated
glomerular filtration rate (eGFR) between 15 mL/min/1.73 m2 or
higher to less than 45 mL/min/1.73 m2, or at 500 mg once-daily to
patients with end-stage renal disease, characterized by an eGFR
less than 15 mL/min/1.73m2, in monotherapy or in combination
therapy with a hypoglycemic agent excluding insulin formulation, to
evaluate safety and tolerability when administered orally for 52
weeks.
The Drug was observed to be safe and well tolerated in Japanese
type 2 diabetic patients with renal impairment and no significant
differences were found in the incidence of adverse events, their
types and severities in this study from previous clinical
studies.
Specifically, most of the adverse events were mild or moderate
in severity. The incidence of serious adverse events was 16.7% (10
of 60 subjects) and causality with the Drug could be ruled out in
all cases. Incidence of adverse events leading to study treatment
discontinuation was also limited (4 of 60 subjects).
At present, administration of the Drug is not recommended for
patients with renal impairment with eGFR less than 45
mL/min/1.73m2. Based on the results of the Study, Sumitomo Pharma
is planning to conduct discussions with the regulatory authorities
in Japan, on revising the package insert in fiscal 20241 for
patients with renal impairment with eGFR less than 45
mL/min/1.73m2.
About TWYMEEG®
TWYMEEG® is the first agent in a class of
tetrahydrotriazine-containing molecules. It is thought that the
Drug shows a glucose lowering effect by both a pancreatic action
that promotes glucose concentration-dependent insulin secretion and
an extra-pancreatic action that improves glucose metabolism in the
liver and skeletal muscle (suppression of gluconeogenesis and
improvement of glucose uptake), through acting on mitochondria. The
Drug has the potential to prevent endothelial and diastolic
dysfunction, which could provide protective effects on micro- and
macrovascular defects induced by diabetes. It may also have
protective effects on pancreatic β cell survival and function.
Owing to its unique mechanism of action, the Drug is widely used
for glucose lowering in the treatment of type 2 diabetes, either as
monotherapy or as an add-on to other therapies for this
purpose.
In October 2017, Sumitomo Pharma concluded a development and
commercialization partnership agreement for Japan, Chinese
mainland, Taiwan, Korea and nine Southeast Asian countries with
Poxel SA (Head Office: Lyon, France; CEO: Thomas Kuhn) and started
selling the Drug in Japan in September 2021.
About Sumitomo Pharma Co., Ltd.
Sumitomo Pharma Group defines its 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, the Group aims to
provide innovative and valuable pharmaceutical and healthcare
solutions to people in Japan and around the world in order to
realize its Mission. The Group will remain committed to research
and development with the aim of continually discovering excellent
pharmaceuticals, regenerative medicine/cell therapy,
non-pharmaceutical products, and others with a focus on the
Psychiatry & Neurology and Oncology as priority disease
areas.
For more detail, please visit our website.
(https://www.sumitomo-pharma.com)
About Poxel SA
Poxel is a clinical stage biopharmaceutical company
developing innovative treatments for chronic serious diseases
with metabolic pathophysiology, including non-alcoholic
steatohepatitis (NASH) and rare disorders. For the treatment of
NASH, PXL065 (deuterium-stabilized R-pioglitazone) met its
primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In
rare diseases, development of PXL770, a first-in-class
direct adenosine monophosphate-activated protein kinase (AMPK)
activator, is focused on the treatment of adrenoleukodystrophy
(ALD) and autosomal dominant polycystic kidney disease (ADPKD).
TWYMEEG® (Imeglimin), Poxel’s first-in-class product that
targets mitochondrial dysfunction, is marketed for the treatment of
type 2 diabetes in Japan by Sumitomo Pharma and Poxel expects to
receive royalties and sales-based payments. Poxel has a strategic
partnership with Sumitomo Pharma for Imeglimin in Japan, China, and
eleven other Asian countries. 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. The Company does not endorse or is
not otherwise responsible for the content of external hyperlinks
referred to in this press release.
1 Sumitomo Pharma fiscal year 2024 ends March 31, 2025.
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version on businesswire.com: https://www.businesswire.com/news/home/20240806261803/en/
Corporate Communications Sumitomo Pharma Co., Ltd. E-mail:
prir@sumitomo-pharma.co.jp
Investor relations / Media NewCap Nicolas Fossiez,
Aurélie Manavarere / Arthur Rouillé investor@poxelpharma.com +33 1
44 71 94 94
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