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 its participation at the 64th Annual Meeting of the Japan Diabetes Society (May 20-22, 2021).
Three presentations on Imeglimin will be included in an oral session for large clinical studies in the afternoon (2:30 pm to 3:40 pm JST) of May 20. These presentations will be focused on the analysis and interpretation of clinical data derived from Phase 2 and Phase 3 (TIMES program) trials with Imeglimin, Poxel's novel antidiabetic investigational drug, where Japanese patients with type 2 diabetes (T2DM) were enrolled and studied:
- TIMES 2: Long-term Phase 3 study with Imeglimin as a mono- and add-on therapies in Japanese T2DM
- Phase 2 and TIMES Post-hoc analysis of clinical studies in Japan: efficacy safety by age, kidney function and body mass index
- Phase 2 and TIMES Post-hoc analysis of clinical studies in Japan: efficacy by insulin secretion deficiency or insulin resistance
Further, Imeglimin will also be discussed in Symposium 21, "New therapies utilizing metformin and concomitant use of new drugs" on May 22 (8:30 am to 11:30 am JST).
The event is dedicated to diabetes care and research. To learn more about the event: https://site.convention.co.jp/64jds/en/
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. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210511005905/en/
Contacts:
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
