- Phase 1 data in Japanese subjects demonstrated Imeglimin was safe, well tolerated and exhibited a similar pharmacokinetic profile to what was observed in Caucasian subjects
- Mechanistic data shows Imeglimin’s benefit on beta cell protection and details its unique insulin secretion pathway in response to glucose
LYON, France--(BUSINESS WIRE)-- POXEL SA (Euronext – POXEL - FR0012432516), a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders, including type 2 diabetes, announced today the presentation of a comprehensive summary of the Phase 1 data of Imeglimin in Japanese subjects (healthy volunteers) and additional preclinical mechanistic data on Imeglimin’s unique mechanism of action in insulin secretion in response to glucose. The data were presented in two oral presentations at the 9th Scientific Meeting of the Asian Association for the Study of Diabetes (AASD) in Nagoya, Japan. Imeglimin has completed Phase 1 and Phase 2 development in approximately 1,200 patients and subjects in the U.S., EU and Japan and is ready for Phase 3 development.
“We are honored to have the opportunity to present at this prestigious scientific diabetes meeting. The presentations include Imeglimin Phase 1 results from the study conducted in Japanese subjects, as well as important mechanistic data, which we believe may be in part related to the robust Phase 2b efficacy results seen in Japanese patients,” said Thomas Kuhn, CEO of Poxel. “Diabetes is a growing health concern in Asia, and Japan is a key focus and an integral part of our business strategy. We are encouraged that Imeglimin could become an innovative new treatment option for Japanese patients with type 2 diabetes. Based on its differentiated product profile, Imeglimin is a prime candidate for first-line monotherapy and as an add-on to other glucose lowering therapies. We anticipate that the Phase 3 program for Imeglimin in Japan will be initiated during the fourth quarter of 2017.”
In the first presentation titled “Safety, Tolerability and Pharmacokinetics of Imeglimin in Healthy Japanese Subjects,” Poxel’s Chief Scientific Officer presented a summary of the full data set from the double-blind, randomized and placebo-controlled Phase 1 study in 48 Japanese subjects. The data demonstrated a good tolerability profile of up to 6,000 mg with no safety signals identified after a seven-day multiple-dose regimen. The pharmacokinetics observed in Japanese subjects was consistent with previous observations in the Caucasian study.
The second oral presentation titled “Imeglimin Increases Insulin Secretion in Response to Glucose as a Unique Mechanism of Action Depending on NAD Synthesis,” provides data that further strengthens the understanding of Imeglimin’s unique mechanism of action resulting in an improvement of insulin secretion in response to glucose. This response has been shown in different preclinical models of diabetes as well as in type 2 diabetic patients. This increase in insulin secretion in response to glucose was demonstrated to be dependent on Imeglimin’s effect on nicotinamide adenine dinucleotide (NAD) biosynthesis, a crucial component of mitochondrial function. In addition to improving beta cell function, Imeglimin has also been shown to preserve the beta-cell mass, which could potentially delay disease progression. Furthermore, a synergistic effect between Imeglimin and GLP-1 on insulin secretion in response to glucose was observed, highlighting a distinct mode of action compared to GLP-1. In addition to being a prime candidate for monotherapy, these data also support use of Imeglimin in combination therapy with GLP-1 agonists and DPPIV inhibitors.
“We have made significant progress in understanding how Imeglimin’s unique dual mechanism of action improves both insulin sensitivity and insulin secretion, which are the two key defects that cause type 2 diabetes,” commented Sebastien Bolze, Pharm.D, PhD, Poxel’s Chief Scientific Officer and Executive Vice President, Non-Clinical Development. “Imeglimin’s effect on insulin secretion could be particularly well-suited for Japanese type 2 diabetes patients because they may experience an early defect of insulin secretion. This important effect may have also contributed in part to the strong efficacy seen in our Phase 2b study in Japanese patients.”
Both presentations from the 9th scientific meeting of the AASD are available on the Company’s website under “Scientific Publications” or by using the following link http://poxel.com/our-science/scientific-publications.php
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)
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
Released May 22, 2017