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 the presentation of new results from Imeglimin Phase 2 and 3 clinical trials at the Japan Diabetes Society’s 64th Annual Meeting, which will be held virtually (May 20-22, 2021).
Imeglimin is a novel agent that acts on both of the major 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 received and presented by Poxel’s clinical development team in collaboration with its partner Sumitomo Dainippon Pharma and leading diabetologists in Japan.
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TIMES 2: Long-term efficacy and safety in phase 3 study with imeglimin as monotherapy and add-on therapy in Japanese T2DM: results of the TIMES-2 study
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Open, non-placebo-controlled, multicenter study to evaluate the long-term safety / efficacy of imeglimin over 52 weeks as a mono- and add-on to other available individual antidiabetic agents in Japanese T2DM patients
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Adverse events were generally mild and consistent with the known safety / tolerability profile. There was no severe hypoglycemia
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Changes from baseline in HbA1c ranged from -0.56 ± 0.08 to -0.92 ± 0.11% in patients receiving imeglimin added to other oral antidiabetic agents
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Post hoc analysis of phase 2 and phase 3 studies of imeglimin – efficacy and safety in patients of different backgrounds, including the elderly and those with renal impairment
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Further analysis of data from key subgroups – based on age, kidney function or body mass index (BMI) – from the completed Japanese phase 2b and TIMES1 phase 3 studies
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Treatment with imeglimin resulted in similar efficacy (HbA1c reduction) regardless of age, kidney function and BMI. The safety profile was also consistent across each subgroup and when compared to the wider population
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Post-hoc analyzes of phase 2 and phase 3 studies on the efficacy of imeglimin in patients with impaired insulin secretion or impaired insulin sensitivity
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Further analysis of data from the completed Japanese Phase 3b, TIMES 1, and TIMES 2 Phase 3 studies
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Subpopulations of patients with more or less severe insulin resistance and impaired insulin secretion were identified using standard indices (the value of HOMA-IR, QUICKI and HOMA-β at the start of the study or a combination of these indices).
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The effects of imeglimin in reducing HbA1c were similar in subgroups of patients with predominant insulin resistance or impaired insulin secretion
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“In TIMES 2, the largest of our major Phase 3 studies, we found that imeglimin, both as monotherapy and when added to other commonly used antidiabetic agents, produced a clinically meaningful and sustained reduction in HbA1c,” said Pascale Fouqueray, Executive Vice President of Clinical Development and Regulatory Affairs at Poxel. “Consistent with imeglimin’s dual mechanism of action, it was also important to confirm that imeglimin can perform well across the spectrum of pathophysiological defects in insulin action and secretion. We are also delighted that imeglimin appears to be similarly safe and effective in subgroups with greater unmet medical need – especially in the elderly and those with modest renal impairment. ”
Imeglimin will also be discussed on May 22nd at Symposium 21 “New therapies using metformin and simultaneous use of new drugs”.
“We are proud of our work in Japan and are particularly pleased about our strong partnership with Sumitomo Dainippon Pharma, the leading pharmaceutical company in Japan, when it comes to providing solutions for patients with diabetes,” commented Thomas Kuhn, CEO of Poxel. “We look forward to completing the J-NDA review of Imeglimin. Based on a typical 12 month review by the PMDA, we believe that Imeglimin could be approved in mid-2021 with an expected 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 know-how to develop innovative drugs for metabolic diseases with a focus on type 2 diabetes and non-alcoholic steatohepatitis (NASH) and selected rare hereditary diseases including adrenoleukodystrophy. The company is currently promoting three drug candidates in its mid- to late-stage pipeline. There are several earlier options as well. 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 under review 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 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 PXL770 as well 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 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, 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 that could potentially impact 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, about 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”, “May”, “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.
1 year is the fiscal year from April 2021 to March 2022, the fiscal year of Sumitomo Dainippon Pharma.
