Laquinimod: Phase IIa data

A double-blind, international Phase IIa trial in 180 patients with moderate to severe CD showed that once-daily 0.5 mg oral laquinimod improved remission (48.3% vs. 15.9%) and response (62.1% vs. 34.9%) rates from baseline after 8 weeks vs. placebo. The 1 mg dose of laquinimod led to a 26.7% remission rate and a 53.3% response rate. Teva said the 1.5 and 2 mg doses of laquinimod had no effect on response or remission rates. The company said the study was exploratory in nature and thus no formal hypothesis testing was planned and no statistical comparisons were performed. The 0.5 and 1 mg doses of laquinimod were generally well tolerated with adverse events similar to placebo. Patients received placebo or once-daily 0.5, 1, 1.5 or 2 mg laquinimod for 8 weeks. Data were presented at the United European Gastroenterology meeting in Amsterdam. Active Biotech and Teva said they are analyzing the data to finalize next steps, which include Phase II/III testing. ...