18-week Phase 2 Study Confirms Imeglimin’s Unique Profile with Dual Effect on Improving Insulin Secretion and Sensitivity

PXL770 Demonstrates Direct Activation of the AMP Kinase and Promising Therapeutic Potential for Type 2 Diabetes

LYON, France--(BUSINESS WIRE)-- POXEL SA (Euronext – POXEL - FR0012432516), a biopharmaceutical company focused on the development of innovative drugs to treat type 2 diabetes, today announced the presentation of data on its two lead pipeline programs at the World Congress on Insulin Resistance and Cardiovascular Diseases (WCIRDC), which was held last week in Los Angeles. On November 19^th, the Company presented clinical data and in depth analysis demonstrating Imeglimin’s premium potential as a novel type 2 diabetes monotherapy improving insulin secretion and insulin sensitivity in diabetic patients from an 18-week phase 2 study. On November 20^th, the Company presented exciting preclinical data for its next pipeline compound, PXL770, a direct adenosine monophosphate-activated protein kinase (AMPK) activator. The study showed that PXL770 improved glycemic control and produced an improved lipid profile in an established model of type 2 diabetes.

“The data announced last week are part of our initiative to confirm Imeglimin’s novel mechanism of action in patients which further establishes its potential as an innovative treatment for type 2 diabetes,” said Thomas Kuhn, CEO of Poxel. “In addition, Poxel continues to solidify its leadership position in this therapeutic area with data on PXL770, our next pipeline program, which will enter the clinic at the end of the year.”

In an 18-week randomized, double blind, placebo-controlled parallel phase 2 trial, Imeglimin improved glucose sensing, leading to an increase in insulin secretion and improved insulin sensitivity as shown by several biomarkers. Imeglimin’s mechanism of action targets the mitochondria bioenergetics, which in this study translated into a decrease in both fasting and post-prandial glycemia as well as a robust decrease in A1c, consistent with already published data from previous combination trials and the large scale phase 2b trial. In addition, the study supported Imeglimin’s positive safety profile, re-confirming the safety and tolerability data generated by all 14 clinical trials conducted with Imeglimin to date. Topline data from this study, including data points, were originally announced in a press release on June 4^th, 2015.

In a second poster, Poxel provided the first publicly presented data on their second pipeline product, PXL770, a direct AMPK activator. PXL770 significantly improved glucose tolerance and normalized A1c levels without increasing insulin concentrations after 6-weeks of oral administration in an obese type 2 diabetes mouse model, suggesting an insulin sensitizing effect. Furthermore, PXL770 normalized plasma and liver triglycerides as well as liver weight. In this mouse model, PXL770 significantly increased AMPK activity in both liver and muscle, further demonstrating in vivo target engagement. Together these results showed the strong potential of PXL770 as a novel oral agent for the treatment of type 2 diabetic patients with added benefits on lipid abnormalities.

About Imeglimin

Imeglimin is the first in a new chemical class of oral anti-diabetic agents, the Glimins. Imeglimin acts on three main target organs involved in glucose homeostasis: the liver, muscle, and the pancreas. Imeglimin’s unique mechanism of action targets the mitochondria bioenergetics. 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 PXL770

PXL770 directly activates adenosine monophosphate-activated protein kinase (AMPK), an enzyme that acts as an energy sensor and regulator, maintaining cellular homeostatis, thus playing an important role in the management of diabetes. In addition to its anti-diabetic properties, PXL770 has the potential to treat lipid-related abnormalities, which are present in a vast majority of diabetic patients and are the cause of cardiovascular incidents among this population.

About Poxel

Poxel uses its unique development expertise in metabolism to advance a pipeline of truly novel products currently focused on type 2 diabetes. Our first-in-class lead product, Imeglimin, targeting mitochondrial dysfunction, has successfully completed Phase 2 development in the US and EU and has entered clinical development in Japanese subjects. We are advancing our second program, PXL770, a direct AMPK activator, through clinical proof-of-concept. We will generate further growth through strategic partnerships and pipeline development. (Euronext: POXEL, www.poxel.com)

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Investor relations / Media - EU/US
MacDougall Biomedical Communications
Gretchen Schweitzer or Stephanie May, + 49 89 2424 3494 or + 49 172 861 8540
smay@macbiocom.com
or
Investor relations / Media - France
NewCap
Florent Alba/Nicolas Mérigeau, + 33 1 44 71 98 55
poxel@newcap.fr

Source: Poxel

Released November 23, 2015