Poxel plots Japanese path for diabetes therapy

Poxel S.A. (Euronext:POXEL) gained €1.78 (30%) to €8.30 on Thursday after it said all three dose levels of imeglimin met the primary endpoint in a Japanese Phase IIb trial to treat Type II diabetes. The company hopes to begin Phase III testing in Japan in 4Q17, pending feedback from a meeting with local regulators next quarter.

Poxel CEO Thomas Kuhn told BioCentury that Japanese regulators will not require the company to conduct a cardiovascular outcomes trial (CVOT), as U.S. regulators would. Kuhn also said imeglimin could be a first-line treatment option in Japan, where any oral agent can be used in that setting for Type II diabetes. In the U.S. and EU, metformin is recommended in the first-line setting. Imeglimin is an inhibitor of mitochondrial permeability transition pore (mPTP) opening...