FDA agrees on third laquinimod trial

Active Biotech AB (SSE:ACTI) gained SEK6.35 (13%) to SEK56.25 on Wednesday after it and partner Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) announced an agreement with FDA on an SPA for a third Phase III trial of laquinimod to treat relapsing-remitting multiple sclerosis (RRMS). The two-year CONCERTO trial is slated to start by year end or early next year in about 1,800 patients. It will evaluate the same laquinimod dose used in the first two Phase III trials -- once-daily 0.6 mg -- as well as a 1.2 mg once daily dose. The primary endpoint will be confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS), which was a secondary endpoint that the 0.6 mg dose met in the two prior trials -- BRAVO and ALLEGRO.

Teva said the 1.2 mg dose was evaluated for four weeks in an ascending-dose trial that evaluated doses of up to 2.7 mg. The company noted that "overall it appears that no new safety signals emerge" as doses increase. ...