Sosei initiates Ph II clinical trial of AD337 in FMS

Tokyo, Japan-based bioventure company Sosei has intiated a Phase II trial of AD337 as a treatment for fibromyalgia syndrome. Its drug candidate is an enantiomer of an already-approved non-opioid analgesic.

The multicenter, randomized, double-blind, placebo-controlled trial will evaluate the safety, tolerability and efficacy of the agent in about 100 FMS patients in 20 centers across Australia and the UK.

Sosei noted that, in Phase I trials, its serotonin noradrenaline re-uptake inhibitor demonstrated an attractive pharmacokinetic profile in 49 subjects, and also displayed good tolerability. The firm added that it has comparable pharmacologic activity to other drugs that are effective against FMS.