Mitsubishi starts Ph II/III of fasinumab to treat OA

Mitsubishi Tanabe Pharma Corp. (Tokyo:4508) began the Phase II/III J01 trial of fasinumab (REGN475, MT-5547) to treat osteoarthritis (OA). The double-blind, placebo-controlled, Japanese trial is evaluating 3 dosing regimens of subcutaneous fasinumab in about 568 patients with moderate to severe pain due to OA of the knee or hip.

The primary endpoint is the change from baseline to week 16 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score. Secondary endpoints include patient global assessment, WOMAC physical function score, WOMAC stiffness score, WOMAC total score and safety...