Sosei has completed a Phase II trial of AD 337 for the treatment of fibromyalgia.
The multicenter, randomized, double-blind, placebo-controlled, parallel group trial investigated the efficacy, safety and tolerability of AD 337 in female subjects. The trial enrolled 103 patients across 18 centers in the UK and Australia with the primary study endpoint being the difference in the Fibromyalgia Impact Questionnaire score between active and placebo after four weeks of treatment, Sosei said.
Results show the study did not achieve a statistically significant outcome in its primary endpoint. However, statistical significance in the Fibromyalgia Impact Questionnaire was achieved at the one-week time point, and positive trends were seen throughout the study, the company added.
AD 337 was well tolerated and there were no clinically significant changes in vital signs, biochemistry, hematology and cardiovascular parameters, according to the company.
Sosei CEO Shinichi Tamura said the company will evaluate the results of the trial to determine its approach for possible development of AD 337 in fibromyalgia and other potential indications.