Lyon, France, May 27, 2015 - POXEL SA (Euronext: POXEL), a biopharmaceutical company developing innovative drugs to treat type 2 diabetes, today 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. In addition, the Company announced that Dr. Yohjiro Itoh has joined Poxel as Vice President Regulatory and Clinical Development Asia, effective April 7th, 2015 to lead the company's drug development and registration efforts in Asia. Both events are critical steps in the Company's strategic focus on the Japanese market for the further development of Imeglimin.
"Japan, as with much of Asia, has an exponentially growing need for diabetes treatments. It is an attractive market for innovative company like Poxel, and we see great value in building a focused presence there," said Thomas Kuhn, CEO of Poxel. "Combined with our promising phase 1 results for Imeglimin in Japanese subjects that will help accelerate Imeglimin development in this country, the addition of Dr. Itoh to our team and his expertise and knowledge of the Japanese regulatory environment will be of great importance to Poxel over the next years as we expand our efforts in Asia."
Dr. Yohjiro Itoh commented: "I am very excited to support Imeglimin Asian development after this innovative compound completed its phase 2b and is ready for phase 3 in the US and Europe and I look forward to contributing to Poxel's success in making Imeglimin available to the Asian markets."
Imeglimin Phase 1 Trial in Japanese Subjects
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. 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.
Appointment of Dr. Yohjiro Itoh
Dr. Itoh brings Poxel over 30 years of life science industry experience with a focus on regulatory affairs. Dr. Itoh joins Poxel from Tokyo-based CRO Mediscience Planning Inc. (MPI), where he served as Head of the Regulatory and Consulting Department. Prior to MPI, he held key positions in both Regulatory Affairs and Clinical Research at Bayer Yakuhin, RPR Gencell, and some other Companies, during which he gained broad knowledge in into variety of fields including cardiovascular diseases, medical devices, oncology and immunology as well as gene therapy. He holds a Ph.D. in Molecular Biology and Immunology from Okayama University, Japan.
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 Poxel SA
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 Japan. 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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