Ability to Delay Type 2 Diabetes Disease Progression by Preserving Beta Cell Mass Observed in New Imeglimin Data

Imeglimin preserves beta cells by increasing beta cell mass and function in type 2 diabetes model

New preclinical data presented at the World Congress on Insulin Resistance, Diabetes and Cardiovascular Diseases in Los Angeles

Important benefits related to Imeglimin’s unique mechanism of action observed in new data

LYON, France--(BUSINESS WIRE)-- POXEL SA (Euronext – POXEL - FR0012432516), a biopharmaceutical company focused on the development of innovative treatments for type 2 diabetes, today announced the presentation of preclinical data supporting Imeglimin’s drug profile as a novel diabetes therapy. The data were presented in a poster and an oral presentation at the 14th World Congress on Insulin Resistance and Cardiovascular Diseases (WCIRDC) in Los Angeles. Imeglimin is currently being studied in a 300-patient Phase 2b clinical trial in Japan and has completed Phase 2 development in over 850 subjects in the US and EU.

The poster presentation titled, “Imeglimin preserves beta-cell function and mass in male Zucker diabetic fatty rats”, demonstrates Imeglimin’s beneficial effect on beta-cell function and its potential to delay the development of type 2 diabetes.

“We are continuing to add further differentiating data to Imeglimin’s exciting clinical results as we learn more about the important benefits of Imeglimin’s unique mechanism of action,” said Harold E. Lebovitz, MD, Professor of Medicine in the Division of Endocrinology and Metabolism/Diabetes at State University of NY, Health Sciences Center, Brooklyn, and a member of Poxel’s Scientific Advisory Board. “These preclinical data support Imeglimin's ability to preserve beta cell function by increasing insulin secretion in response to glucose and by preserving beta cell mass by decreasing beta cell death and increasing its reproduction, and, if reproducible in humans, could delay and/or treat type 2 diabetes progression."

“Our goal is to provide patients with new differentiated treatment options to help manage their disease,” said Thomas Kuhn, CEO of Poxel. “Through mid-2017, we expect to present further differentiating data demonstrating Imeglimin’s potential for cardiovascular-related benefits, and we are on track to deliver results from the 300-patient Phase 2b study in Japan during the second quarter of 2017.”

In the study, 7-week old Zucker diabetic fatty rats were treated orally with 150mg/kg Imeglimin twice-daily for 5 weeks. Imeglimin treatment resulted in preservation of islet architecture, increased beta-cell mass by 41% (p<0.01), decreased beta-cell apoptosis by 52% (p<0.05) and increased the proportion of proliferating cells by 111% (p<0.001), as compared to controls. These data highlight Imeglimin’s potential to delay type 2 diabetes disease onset and progression through the preservation of beta cell mass and the improvement of beta-cell function. Furthermore, the study confirmed Imeglimin’s beneficial effect on glucose tolerance and insulin secretion in response to glucose in a model of disease progression.

The poster presented at the WCIRDC is available on the Company’s website under “Scientific Publications” or by using the following link http://poxel.com/our-science/scientific-publications.php.

About Imeglimin

Imeglimin is the first in a new chemical class of oral anti-diabetic agents, the Glimins. Imeglimin acts on the three main target organs involved in glucose homeostasis: the liver, muscle, and the pancreas. Imeglimin has a unique mechanism of action that targets mitochondrial bioenergetics. This 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, and benefits on beta cell protection and function, which can delay disease progression. This distinct mode of action compared to existing treatments for type 2 diabetes makes Imeglimin a prime candidate in monotherapy and to complement other treatments such as metformin or sitagliptin.

About Poxel

Poxel uses its development expertise in metabolism to advance a pipeline of drug candidates focused on the treatment of 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. and EU and have fully enrolled a Phase 2b clinical study in 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)

Poxel SA
Jonae R. Barnes, +1-617-818-2985
Senior Vice President, Investor Relations and Public Relations
Investor relations / Media - EU/US
MacDougall Biomedical Communications
Gretchen Schweitzer or Stephanie May
+ 49 89 2424 3494 or + 49 175 571 1562
Investor relations / Media - France
Florent Alba/Nicolas Mérigeau, + 33 1 44 71 98 55

Source: POXEL SA