LYON, France & OSAKA, Japan – (BUSINESS WIRE) – POXEL SA (Euronext – POXEL – FR0012432516), a biopharmaceutical company focused on developing innovative treatments for metabolic disorders, including type 2 diabetes and non-alcoholic steatohepatitis (NASH), and Sumitomo Dainippon Pharma Co., Ltd. (Headquarters: Osaka, Japan; Representative Director, President and CEO: Hiroshi Nomura; Securities Code: 4506, First Section of TSE), announced today that a new drug application for TWYMEEG® Tablets 500mg3 (International Nonproprietary Name (INN): Imeglimin hydrochloride) for the treatment of type 2 diabetes was approved in Japan on June 23. Japan is the first country in the world to allow Imeglimin. The TWYMEEG approval is supported by numerous preclinical and clinical studies, including the TIMES phase 3 program (Trials of IMeglimin for Efficacy and Safety), which is jointly administered by Poxel and Sumitomo Dainippon Pharma, and three pivotal studies to evaluate the efficacy and Security from TWYMEEG in over 1,100. included patients. In all three studies, TWYMEEG met its primary endpoints and goals and demonstrated a favorable safety and tolerability profile.
“The TWYMEEG approval in Japan is an important milestone for Poxel and the culmination of several years of clinical development work. This approval is a strong confirmation of our R&D capabilities and our international presence. Our vision as a company is focused on developing and commercializing innovative drugs for metabolic diseases.” said Thomas Kuhn, CEO of Poxel. “We will continue to support Sumitomo Dainippon Pharma in establishing TWYMEEG as the key therapy for type 2 diabetes in Japan and other countries where” Sumitomo Dainippon Pharma owns the rights to the product. Our efforts are also focused on our two First-in-class programs to treat NASH, PXL770 and PXL065, as well as to promote earlier opportunities for our adenosine monophosphate activated protein kinase (AMPK) activator and deuterated thiazolidinedione (TZD) platforms in the field of rare metabolic diseases. ”
The TIMES Phase 3 program was a joint development between Poxel and Sumitomo Dainippon Pharma. The companies entered into a strategic partnership in October 2017 to develop and commercialize TWYMEEG in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries. 9 million) 5 milestone payment to Poxel. In addition, post-launch Poxel will be entitled to rising double-digit royalties on net sales and revenue-based payments of up to JPY26.5 billion (approximately $ 200 million, US $ 230 million) 6 in accordance with sales targets.
“We believe that TWYMEEG is an important addition to our existing diabetes franchise due to its differentiated dual mechanism of action and its favorable efficacy and safety profile. Based on the clinical data obtained in phases 2 and 3, we believe that it has the potential to be used as monotherapy and in combination with other existing therapies, specifically to complement our existing infrastructure in type 2 diabetes. This approval of TWYMEEG allows us to give patients with type 2 diabetes the option of greater flexibility in their treatment regimens, ”said Koichi Kozuki, executive officer, Drug Development Division of Sumitomo Dainippon Pharma. “We strive to provide new therapeutic options to help patients cope with their illness.”
About TWYMEEG (INN: Imeglimine Hydrochloride)
Imeglimin is the first active ingredient in a new chemical class of tetrahydrotriazine-containing molecules. It is believed that TWYMEEG exhibits a blood sugar lowering effect through both a pancreatic effect, which promotes glucose concentration-dependent insulin secretion, and an extrapancreatic effect, which improves glucose metabolism in the liver and skeletal muscles (suppresses gluconeogenesis and improves glucose uptake) through an action on mitochondria . This mechanism of action (MOA) has the potential to prevent endothelial and diastolic dysfunction, which could have a protective effect on micro- and macrovascular defects caused by diabetes. It also has the potential for protective effects on beta cell survival and function. This unique MOA offers imeglimin the potential opportunity to be a candidate for the treatment of type 2 diabetes at almost all stages of the current antidiabetic treatment paradigm, including monotherapy or as an adjunct to other hypoglycemic therapies.
Via 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 studies in over 1,100 patients, of whom the non-control subjects received the 1,000 mg dose twice Every day. Preliminary results from the three studies were released in April press releases. 4, 2019 (TIMES1), December 20, 2019 (TIMES2) and June 25, 2019 (TIMES3).
– TIMES1: A 24-week, double-blind, placebo-controlled, randomized, phase 3 monotherapy study evaluating the efficacy, safety, and tolerability of imeglimin in Japanese patients with type 2 diabetes.
– TIMES2: A 52-week, open-label, phase 3, parallel-group study to evaluate the long-term safety and efficacy of imeglimin in Japanese patients with type 2 diabetes. In this study, imeglimin was administered orally as a combination therapy with approved antidiabetic drugs, including a DPP-4 inhibitor, an SGLT2 inhibitor, metformin, a sulfonylurea, a glinide, an alpha-glucosidase inhibitor, a thiazolidinedione, and a GLP1 receptor agonist or as monotherapy.
– TIMES3: A 16-week, double-blind, placebo-controlled, randomized phase 3 study with a 36-week open-label extension phase to evaluate the efficacy and safety of imeglimin in combination with insulin in Japanese patients with type 2 diabetes and Japanese patients with Type 2 diabetes on insulin therapy with insufficient glycemic control.
About Poxel SA
Poxel is a dynamic biopharmaceutical company that uses its extensive know-how in the development of innovative drugs for metabolic diseases with a focus on type 2 diabetes and non-alcoholic steatohepatitis (NASH) as well as selected rare hereditary diseases such as adrenoleukodystrophy. The company is currently developing three drug candidates in its mid- to late-stage pipeline; several options in earlier stages are also underway. Imeglimin, Poxel’s leading top product, targets mitochondrial dysfunction. Poxel has a strategic partnership with Sumitomo Dainippon Pharma for TWYMEEG (Imeglimin) in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries. In Japan, a new drug application for TWYMEEG for the treatment of type 2 diabetes was approved. After successfully completing a phase 2a feasibility study for the treatment of NASH that met its primary endpoint and study objectives for PXL770, a world-class direct adenosine monophosphate activated protein kinase (AMPK) activator, Poxel plans to launch a phase in the second half of 2021 2b program to be initiated. PXL770 may also have the potential to treat other metabolic disorders. PXL065 (deuterium-stabilized R-pioglitazone) is in an optimized phase 2 study for the treatment of NASH. Poxel also has other early-stage programs in its AMPK Activator and Deuterated Thiazolidinediones (TZD) platforms that target chronic and rare metabolic disorders. The company intends to generate further growth through strategic partnerships and the development of pipelines. Poxel is listed on Euronext Paris and is headquartered in Lyon, France with subsidiaries in Boston, MA and Tokyo, Japan. Further information is available at: www.poxelpharma.com
In connection with 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 any material adverse effects on its business from the still unresolved COVID-19 pandemic. However, the company believes that the COVID-19 pandemic could have further material adverse effects on its business. The global impact of COVID-19 could have a significant impact on the company’s internal organization and efficiency, particularly in countries where it operates and where containment measures are being taken by the authorities. In addition, COVID-19 can affect market conditions and the company’s ability to seek additional funding or partner up. In particular, there may be delays in the provision of medicines or drugs, in the initiation or timing of the results of preclinical and / or clinical studies, as well as delays related to the responsiveness of regulatory authorities that may affect the Company’s development programs and partner programs. The company will continue to actively monitor the situation.
About Sumitomo Dainippon Pharma
Sumitomo Dainippon Pharma defines its corporate mission as “contributing broadly to society by creating value based on innovative research and development activities to improve health care and lead a more fulfilling life for people around the world”. By directing our efforts into the research and development of new drugs, we want to realize our mission and offer innovative and effective pharmaceutical solutions not only in Japan but worldwide. The goal of Sumitomo Dainippon Pharma is to develop innovative pharmaceutical products in the research areas of psychiatry and neurology, oncology and regenerative medicine / cell therapy. Please visit our website for more details. (URL: https://www.ds-pharma.com)
All statements in this press release about future events that are not historical facts are (i) subject to change without notice and (ii) factors beyond the control of the company. These statements may include, without limitation, all statements that are preceded, followed by, or contain words such as “aim”, “believe”, “expect”, “aim”, “intend”, “may”, “anticipate”, “estimate” “,“ Plan ”,“ project ”,“ will ”,“ can ”,“ likely ”,“ should ”,“ would ”,“ could ”and other words and terms with a similar or negative meaning. Forward-looking statements are subject to inherent risks and uncertainties that are beyond the control of the company and that could cause actual results or performance of the company to differ materially from the expected results or performance expressed or implied in such forward-looking statements.
1 Converted at the exchange rate on June 21, 2021.
The second year is the fiscal year from April to March, which is the fiscal year of Sumitomo Dainippon Pharma.
3 Dosage and use: In general, 1,000 mg imeglimine hydrochloride is administered orally twice daily in the morning and evening for adults.
4 Including Indonesia, Vietnam, Thailand, Malaysia, the Philippines, Singapore, the Republic of the Union of Myanmar, the Kingdom of Cambodia and the People’s Democratic Republic of Laos.
5 Converted at the exchange rate on June 21, 2021.
6 Converted at the exchange rate on the day the contract was concluded.