Poxel, the French company that made a €27M IPO last February, announced the successful conclusion of a phase 1 clinical trial in Japanese subjects with Imeglimin, its lead drug candidate. Imeglimin has already completed phase 2 clinical trials in type 2 diabetes patients in the US and EU and is ready for Phase III.
This innovative compound is the first of a new class of oral antidiabetic agents called “glimins“. It basically decreases mitcohondrial respiration, meaning that it targets the key defect associated with all three organs implicated in type II diabetes. Clinical studies to date have proven Imeglimin to have an efficiency comparable to Metformin, the golden standard treatment. Imeglimin, however, has a better safety/tolerability profile and doesn’t induce patient resistance, which Metformin unfortunately does.
The current phase 1 study in Japan was conducted with a design comparable to the previous one performed on Caucasian subjects. Overall, the results indicate that Imeglimin exhibits an excellent safety profile and pharmacokinetics in Japanese subjects, similar to results previously achieved in subjects in the US and EU. These results fully support the initiation of the phase 2 trial in Japanese patients, which is due to start in the second half of 2015.
Japan embodies a strategic market for Poxel. In 2011, 23.1% of the population were aged 65 and above, a percentage that is forecasted to increase by 38% by 2055. A golden mine for diabetes drug-majers as the disease seems to correlated to populations aging!
While Poxel conducted the trial in Japan, the company seized the moment to grab a talented new recrute for its Asian team. The company announced that Dr. Yohjiro Itoh has joined Poxel as Vice President Regulatory and Clinical Development Asia, to lead the company’s drug development and registration efforts in Asia. Dr. Itoh brings Poxel over 30 years of life science industry experience with a focus on regulatory affairs from Tokyo-based CRO Mediscience Planning, Bayer Yakuhin, RPR Gencell, and other companies.
Poxel is now looking for a partner to carry out its phase III programs in Europe and the United States. This last result and latest recruitment in Japan are showing to potential partners that Poxel has more than one string to its bow.