Clinical Trials

Date: 2017-05-22

Type of information: Presentation of results at a congress

phase: 1

Announcement: presentation of results s at the 9th Scientific Meeting of the Asian Association for the Study of Diabetes (AASD)

Company: Poxel (France)

Product: imeglimin

Action mechanism: glimin. 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, the muscle, and the pancreas and has therefore a distinct mode of action compared to existing treatments for Type 2 diabetes. Imeglimin has shown a significant anti-diabetic efficacy combined with an excellent tolerance in earlier monotherapy clinical trials.

Disease: type 2 diabetes

Therapeutic area: Metabolic diseases

Country: Japan

Trial details:

Latest news:

• • On May 22, 2017, Poxel announced the presentation of a comprehensive summary of the Phase 1 data of imeglimin in Japanese subjects 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. Poxel anticipates 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.
• • On May 27, 2015, Poxel, a biopharmaceutical company developing innovative drugs to treat type 2 diabetes, announced the successful conclusion of a phase 1 clinical trial in Japanese subjects with imeglimin, its lead drug candidate that has already completed phase 2 clinical trials in type 2 diabetes patients in the US and EU. The current phase 1 study was conducted as a single and repeated administration dose-escalating study with a design comparable to the previous one performed in Caucasian subjects. This randomized, double-blind, placebo-controlled phase 1 study was conducted in 24 healthy Japanese subjects (men and women). Imeglimin pharmacokinetics, safety and tolerability were assessed after single and 7-day repeated oral treatment with ascending doses. Overall, the results indicate that imeglimin exhibits an excellent safety profile in Japanese subjects, similar to results previously achieved in subjects in the US and EU. In addition, imeglimin’s pharmacokinetics profile in Japanese subjects was comparable to that of Caucasian subjects.

Is general: Yes