Kaku et al. Long-term efficacy and safety in the phase 3 study with Imeglimin as monotherapy and add-on treatment in Japanese T2DM patients: results from the TIMES 2 trial
Hata et al. Post hoc analysis of phase 2 and 3 studies with Imeglimin – similar efficacy and consistent safety in patients of different history, including elderly patients and those with renal impairment
Kondo et al. Post-Project Analysis of Phase 2 and 3 Imeglimin Studies – Similar Effectiveness in Patients with Impaired Insulin Secretion or Impaired Insulin Sensitivity
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), today announced the presentation of new results from Imeglimin’s 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 new agent that works on the two main defects of 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 Poxel’s 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 meglimin produced clinically significant and sustained reductions in HbA1c both as monotherapy and in combination with other commonly antidiabetic drugs. used, ”said Pascale Fouqueray, Executive Vice President of Clinical Development and Regulatory Affairs at Poxel. “Consistent with the dual mechanism of action of Imeglimin, it was also important to confirm that Imeglimin could function well across the spectrum of pathophysiological abnormalities in insulin action and secretion. We are also very glad that Imeglimin appears to be equally safe and effective in subgroups with high need – particularly elderly patients and those with modest kidney function. “
Imeglimin will also be discussed in Symposium 21 “New Therapies Using Metformin and Concomitant Use of New Drugs” on May 22.
“We are proud of our work in Japan and are particularly pleased with our strong partnership with Sumitomo Dainippon Pharma, the pharmaceutical industry leader in Japan in providing solutions to patients with diabetes,” commented Thomas Kuhn, CEO of Poxel. “We look forward to the completion of the Imeglimin J-NDA review and based on a typical 12 month PMDA review, we believe the Imeglimin could be approved in mid-2021 with a product launch planned by our partner Sumitomo Dainippon Pharma in Fiscal Year 20211. “
About Poxel SA
Poxel is a dynamic biopharmaceutical company which uses its vast expertise in the development innovative drugs for metabolic diseases, with particular attention to Type 2 diabetes and non-alcoholic steatohepatitis (NASH), and some rare inherited disorders, including adrenoleukodystrophy. In its intermediate to advanced pipeline, the Company is currently promoting three drug candidates; several early stage opportunities are also underway. Imeglimin, Poxel’s first flagship product, targets mitochondrial dysfunction. Poxel has a strategic partnership with Sumitomo Dainippon Pharma for Imeglimin in Japan, China, South Korea, Taiwan and nine other countries in Southeast Asia. A new Japanese drug application (J-NDA) is being reviewed by the Pharmaceuticals and Medical Devices Agency (PMDA) to seek approval to manufacture and market 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 and study objectives, to PXL770, the first direct activator of adenosine monophosphate activated protein kinase (AMPK), Poxel plans to launch a phase 2b program in the second half of 2021. PXL770 may also have the potential to treat other metabolic diseases. PXL065 (Deuterium stabilized R-pioglitazone), an MPC inhibitor, is in a streamlined Phase 2 trial for the treatment of NASH. Poxel also has additional early stage programs of its AMPK activator and deuterated TZD platforms targeting chronic and rare metabolic diseases. The Company intends to generate additional 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 epidemic, which was declared a pandemic by the World Health Organization (WHO) on March 12, 2020, the Company regularly reviews the impact of the epidemic on its activities.
As of the date of this press release, and based on publicly available information, the Company has not identified any significant adverse effects on its business due to the COVID-19 pandemic which is still unresolved. However, the company predicts that the COVID-19 pandemic could have a significant negative impact on its business operations. The global impact of COVID-19 may in particular affect the internal organization and efficiency of the Company, in particular in the countries where it operates and where containment measures are implemented by the authorities. Additionally, COVID-19 may impact market conditions and the company’s ability to seek additional funding or enter into partnerships. In particular, delays in the supply of drug substance or drug products, in the launch or timing of the results of preclinical and / or clinical trials, as well as delays related to the responsiveness of regulatory authorities could occur, which could have an impact on the company’s development programs and partnership programs. The Company will continue to actively monitor the situation.
All statements other than statements of historical fact included in this press release regarding future events are subject to (i) change without notice and (ii) factors beyond the control of the Company. These statements may include, but are not limited to, all statements preceded, followed or including words such as “target”, “believe”, “expect”, “aim”, “intend”, “may “,” anticipate “,” estimate “,” “plan”, “plan”, “will”, “may have”, “likely”, “should”, “would”, “could” and other words and terms have a similar meaning or their negative. Forward-looking statements are subject to inherent risks and uncertainties beyond the control of the company which could cause the actual results or performance of the company to differ materially from the expected results or performance expressed or implied by these forward-looking statements;
1 The year shown is the fiscal year from April 2021 to March 2022, which is the fiscal year of Sumitomo Dainippon Pharma.
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