Lyon, France – (BUSINESS WIRE) – POXEL SA (Euronext – POXEL – FR0012432516), a biopharmaceutical company focused on developing innovative therapies for metabolic disorders such as type 2 diabetes and non-alcoholic steatohepatitis (NASH), today announced its attendance at the 64th Annual Meeting of Japan Diabetes Society (May 20-22, 2021).
Three presentations on imeglimin will be included in an oral session for large clinical trials on the afternoon (8:30 p.m. to 3:40 p.m. JST) of May 20. These presentations will focus on the analysis and interpretation of clinical data from the Phase 2 and Phase 3 (TIMES program) studies of Imeglimin, Poxel’s novel anti-diabetic drug, in which Japanese patients with type 2 diabetes (T2DM) were enrolled and studied:
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TIMES 2: Long-term phase 3 study with imeglimin as monotherapy and add-on therapy in Japanese T2DM
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Phase 2 and TIMES post hoc analysis of clinical trials in Japan: efficacy and safety by age, kidney function and body mass index
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Phase 2 and TIMES post-hoc analysis of clinical trials in Japan: efficacy due to lack of insulin secretion or insulin resistance
Imeglimin will also be discussed on May 22nd (8:30 am to 11:30 am JST) at Symposium 21 “New Therapies Using Metformin and Concomitant Use of New Drugs”.
The event is dedicated to diabetes care and research. To find out more about the event: https://site.convention.co.jp/64jds/en/
About Poxel SA
Poxel is a dynamic biopharmaceutical company that uses its extensive know-how to develop innovative drugs for metabolic diseases, with a focus on type 2 diabetes and non-alcoholic steatohepatitis (NASH). The company is currently funding three drug candidates and early-stage opportunities in its mid- to late-stage pipeline. Imeglimin, Poxel’s premium 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 currently being reviewed by the Pharmaceuticals and Medical Devices Agency (PMDA) for approval to manufacture and commercialize imeglimin for the treatment of type 2 diabetes. Upon successful completion of a Phase 2a proof of concept study in the treatment of NASH that meets its primary endpoint and study objectives for PXL770, Poxel’s world-class direct adenosine monophosphate activated protein kinase (AMPK) activator, Poxel plans to use PXL770 could also have the potential to treat additional metabolic disorders. PXL065 (deuterium-stabilized R-pioglitazone), an MPC inhibitor, is in an optimized phase 2 study for the treatment of NASH. Poxel also has additional early stage programs of its AMPK activator and deuterated TZD platforms that target chronic and rare metabolic diseases. The company intends to generate further growth through strategic partnerships and pipeline development. Poxel is listed on Euronext Paris and is headquartered in Lyon, France, with offices 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 unresolved COVID-19 pandemic. However, the company believes that the COVID-19 pandemic could have other material adverse effects on its business. The global impact of COVID-19 can particularly affect the company’s internal organization and efficiency, especially in countries where it operates and where authorities are taking containment measures. In addition, COVID-19 can affect market conditions and the company’s ability to raise additional funding or enter into partnerships. In particular, there may be delays in the delivery of medicines or drugs, in the initiation or timing of the results of preclinical and / or clinical studies, and delays related to the responsiveness of regulators, which could potentially affect the Company’s development programs and partner programs. The company will continue to actively monitor the situation.
All statements in this press release, other than historical facts, contained in relation to future events are (i) subject to change without notice and (ii) factors over which the company has no control. These statements may contain, without limitation, any statements that are preceded by words such as “aim”, “believe”, “expect”, “aim”, “intend”, “may”, “anticipate”, “estimate”, followed by or “Plan”, “Project”, “Will”, “Can”, “Probably”, “Should”, “Would”, “Could” and other words and terms with similar meanings or their negatives. 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 by such forward-looking statements.
