Poxel presents new preclinical data on the improvement of the diastolic function pa…

Data from a model of metabolic syndrome suggest a protective effect of the Imeglimine against diabetic cardiomyopathy

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Lyon, France, June 12, 2017 – 8: 00am – POXEL SA (Euronext – POXEL – FR0012432516), a biopharmaceutical company specializing in the development of innovative treatments against metabolic diseases, including type 2 diabetes, today announced that new preclinical data on the Imeglimine, showing a protective effect against diabetic cardiomyopathy in a model of metabolic syndrome in the rat, have been presented in the form of a poster at the 77th scientific session of the ADA (American Diabetes Association) at the San Diego Convention Center in San Diego, California.

“The diabetic cardiomyopathy is a complication of significant cardiovascular type 2 diabetes which is characterized by diastolic dysfunction. This complication affects approximately 40% of the population affected by type 2 diabetes and is associated with increased morbidity and mortality*. The available treatments of diabetic cardiomyopathy are limited, and these promising results show that the Imeglimine could improve diastolic function and reduce the impact of this important complication of cardiovascular type 2 diabetes, ” said Thomas Kuhn, ceo of Poxel. “These results complement the data previously presented on the protective effect of the Imeglimine on endothelial dysfunction, which is the first step in the development of cardiovascular complications associated to type 2 diabetes. ”

Results of the study with the Imeglimine

The preclinical study in a model of metabolic syndrome in rats was designed to investigate the protective effects of the Imeglimine on diabetic cardiomyopathy. Rats obese Zucker fa/fa, known to develop cardiac dysfunction similar to the cardiomyopathy observed in patients with type 2 diabetes, were treated with 150 mg/kg of Imeglimine twice a day for 9 or 90 days. The effects of the Imeglimine were evaluated on key parameters of left ventricular function (by echocardiography and MRI) and the exploration of hemodynamic (by catheterization of the left ventricle). The study has shown that, very quickly after the start of treatment, the Imeglimine was associated with a significant improvement of all parameters of diastolic dysfunction of the left ventricle in treated rats, compared to untreated controls, suggesting a net beneficial effect on the progression of diabetic cardiomyopathy. Moreover, in this model, the Imeglimine was also associated with an improvement in glucose tolerance. These results corroborate the mechanism of action of the Imeglimine and confirm its protective effect previously highlighted against endothelial dysfunction, an early sign of the complication, cardiovascular disease, and in animal models of diabetes (EASD 2016). These effects newly demonstrated on diastolic dysfunction, in a model of metabolic syndrome, strengthen the therapeutic profile of the Imeglimine in type 2 diabetes, a disease for which heart failure remains a major complication for which few treatments are available.

The poster presented at the meeting of the ADA is available on the Company’s web site or by clicking on this link. (” Imeglimin Protects from Diabetic Cardiomyopathy in the Obese Zucker Rat, protective Effect of the Imeglimine against diabetic cardiomyopathy in rats obese Zucker “).

Phases 1 and 2 of the development of the Imeglimine conducted in approximately 1,200 subjects in the United States, in the EU and Japan are completed, and the Company expects to initiate the Phase 3 program in Japan in the fourth quarter of 2017.

About the Imeglimine
The first representative of a new chemical class of oral agents, the Glimines. The Imeglimine acts on three main target organs involved in glucose homeostasis : the liver, muscles and pancreas. The Imeglimine has a unique mechanism of action which targets the mitochondrial bioenergetics. The result is a potential effect in reducing blood sugar levels, as well as the potential to prevent endothelial dysfunction, which may have protective effects against the micro-and macrovascular complications induced by diabetes, and the benefits of the protection and beta-cell function, which may slow down the progress of the disease. This mode of action distinct from that of existing treatments for type 2 diabetes because of the Imeglimine a candidate of choice as monotherapy and as an adjunct to other treatments such as metformin, or sitagliptin.

About Poxel – www.poxel.com
Poxel is based on its level of development expertise in metabolism to develop and enhance a portfolio of drug candidates, currently focused on type 2 diabetes. We have completed the development of phase 2 in the United States and Europe our product is the most advanced, the Imeglimine, the first of a new class of therapeutic targeting of the mitochondrial dysfunction, and which entered into clinical development to phase 2b in japanese patients. We are continuing the development of our 2nd program, the PXL770, an activator direct AMPK. We intend to generate growth through strategic partnerships and the development of our portfolio.

* Fitchett et al., European Journal of Heart Failure (2017)

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