POXEL Poxel SA

Poxel Presents New Preclinical Imeglimin Data on Improvement in Diastolic Function at the American Diabetes Association Meeting

POXEL SA (Euronext – POXEL - FR0012432516), a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders, including type 2 diabetes, announced today that new preclinical Imeglimin data showing protective effects for diabetic cardiomyopathy in a rat model of metabolic syndrome was presented in a poster session at the 77th American Diabetes Association (ADA) Scientific Session at the San Diego Convention Center in San Diego, California.

“Diabetic cardiomyopathy is characterized by diastolic dysfunction, which is a significant cardiovascular complication affecting approximately 40 percent of the type 2 diabetic population and is associated with an increase in morbidity and mortality.* Treatment options for this condition are limited and these exciting results show that Imeglimin has the potential to improve diastolic function and may reduce the burden of this prominent cardiovascular complication in type 2 diabetes patients,” commented Thomas Kuhn, CEO of Poxel. “These results are additive to previously presented data showing Imeglimin’s protective effect on endothelial dysfunction, which is the first step in the development of vascular disease in the context of cardiovascular complications resulting from type 2 diabetes.”

Imeglimin Results

The preclinical study in a rat model of metabolic syndrome was designed to investigate Imeglimin’s protective effects on diabetic cardiomyopathy. Obese Zucker fa/fa rats, which are known to develop cardiac dysfunction very similar to cardiomyopathy observed in type 2 diabetes patients, were treated with 150 mg/kg Imeglmin twice-daily for 9 and 90 days. The effects of Imeglimin were evaluated through key parameters of both left ventricular (LV) function (echocardiography, MRI) and hemodynamic (LV catheterization). The study demonstrated that very early in the course of treatment, Imeglimin strongly improved all the parameters of LV diastolic dysfunction in the rats compared to untreated controls, suggesting a clear beneficial effect on the progression of diabetic cardiomyopathy. In addition, Imeglimin was also shown to improve glucose tolerance in this model. These results are consistent with its mechanism of action and with previous data showing protective effects on endothelial dysfunction, an early sign of cardiovascular complication, in diabetic animal models (EASD 2016). These newly demonstrated effects on diastolic dysfunction, in a model of metabolic syndrome, further strengthen Imeglimin’s therapeutic profile in type 2 diabetes where heart failure remains a key complication with limited therapeutic options.

The poster presented at the ADA meeting is available on the Company’s website under “Scientific Publications” or by using the link http://poxel.com/ourscience/scientific.php.

  • “Imeglimin Protects from Diabetic Cardiomyopathy in the Obese Zucker Rat”

Imeglimin has completed Phase 1 and Phase 2 development in over 1,200 subjects in the U.S, EU and Japan, and the Company anticipates that it will be in the position to initiate the Phase 3 program in Japan during the fourth quarter of 2017.

About Imeglimin

Imeglimin is the first clinical candidate in a new chemical class of oral agents called the Glimins. Imeglimin has a unique mechanism of action (MOA) that targets mitochondrial bioenergetics. Imeglimin acts on the three main target organs involved in glucose homeostasis: the liver, muscle, and the pancreas. This MOA has the potential for glucose lowering benefits, as well as the potential to prevent endothelial dysfunction, which can provide protective effects on micro- and macro-vascular defects induced by diabetes. The additional protective effect on beta-cell survival and function may lead to a delay in disease progression. This unique mode of action compared to existing treatments for type 2 diabetes makes Imeglimin a prime candidate in all stages of the current anti-diabetic treatment paradigm, including monotherapy or as an add-on to other glucose lowering therapies for the treatment of patients with type 2 diabetes.

About Poxel SA

Poxel uses its development expertise in metabolism to advance a pipeline of drug candidates focused on the treatment of metabolic disorders, including type 2 diabetes. We have successfully completed our Phase 2 clinical program for our first-in-class lead product, Imeglimin, which targets mitochondrial dysfunction, in the U.S., EU and Japan. Our second program, PXL770, a direct AMPK activator, is in Phase 1 development. We intend to generate further growth through strategic partnerships and pipeline development. (Euronext: POXEL, www.poxel.com)

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

EN
12/06/2017

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