LYON, France–(BUSINESS WIRE)–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 presentations of new results from Imeglimin Phase 2 and 3 clinical studies at the 64th Annual Meeting of the Japan Diabetes Society, which is being held virtually (May 20-22, 2021).
Imeglimin is a novel agent that acts on both key defects in type 2 diabetes (T2DM) by improving insulin secretion in response to glucose and insulin sensitivity through a unique mode of action. These new results (summarized below) were obtained and presented by Poxels clinical development team in collaboration with its partner, Sumitomo Dainippon Pharma and leading diabetologists in Japan.
In TIMES 2, which was the largest of our pivotal Phase 3 trials, we found that Imeglimin produced clinically meaningful and sustained reductions in HbA1c both as a monotherapy and when added to other commonly used antidiabetics said Pascale Fouqueray, Executive Vice President of Clinical Development and Regulatory Affairs at Poxel. Consistent with Imeglimins dual mechanism of action, it was also important to confirm that Imeglimin could perform well across the spectrum of pathophysiologic defects in insulin action and secretion. We are also very pleased that Imeglimin appears similarly safe and effective in subgroups with greater unmet medical need in particular elderly patients and those with modest degrees of reduced renal function.
Imeglimin will be also discussed in Symposium 21 New therapies utilizing metformin and concomitant use of new drugs, on May 22.
We are proud of our work in Japan and we are especially pleased by our strong partnership with Sumitomo Dainippon Pharma, the leading pharmaceutical company in Japan when it comes to delivering solutions to patients with diabetes, commented Thomas Kuhn, CEO of Poxel. We look forward to the completion of the J-NDA review of Imeglimin and based on a typical 12-month review by the PMDA, we believe Imeglimin could be approved in mid-2021 with an anticipated product launch by our partner Sumitomo Dainippon Pharma in Fiscal Year 20211.
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), and selected rare inherited disorders including adrenoleukodystrophy. In its mid-to-late-stage pipeline, the Company is currently advancing three drug candidates; several earlier-stage opportunities are also underway. Imeglimin, Poxels 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 Companys 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 Companys 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 Companys 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 Companys 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 Companys control that could cause the Companys 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 Pharmas Fiscal Year.
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
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