Date: 2014-09-12
Type of information: Presentation of results at a congress
phase: 2,3
Announcement: presentation of results at the MS Boston 2014: Joint ACTRIMS-ECTRIMS Meeting being held in Boston, Massachusetts
Company: Teva Pharmaceutical Industries (Israel) Active Biotech (Sweden)
Product: laquinimod
Action mechanism: immunomodulating agent. Laquinimod is a once-daily oral, investigational, CNS-active immunomodulator with a novel mechanism of action being developed primarily for the treatment of relapsing-remitting MS (RRMS) and progressive forms of MS. In extensive non-clinical and clinical studies, laquinimod has demonstrated both anti-inflammatory and neuroprotective properties and effects that have been shown to provide clinically meaningful results.
Disease: relapsing-remitting multiple sclerosis (RRMS)
Therapeutic area: Autoimmune diseases - Neurodegenerative diseases
Country:
Trial details:
Latest news: • On September 12, 2014, Teva Pharmaceutical Industries and Active Biotech announced new follow-up data evaluating the clinical safety of laquinimod in patients with relapsing-remitting multiple sclerosis (RRMS) who were treated with laquinimod in Phase II, Phase III and open-label extension studies for two or more years. The pooled safety analysis of the Phase II LAQ/5063 and the Phase III ALLEGRO and BRAVO extension studies supports findings observed in the core studies where currently identified risks were observed within the first months of laquinimod treatment. These data will be presented as part of a platform presentation, September 12, 2014, at the MS Boston 2014: Joint ACTRIMS-ECTRIMS Meeting being held in Boston, Massachusetts. In the pooled safety analysis, rates of adverse events (AEs) and serious AEs were lower in the open-label extensions than in the core studies and less than three percent of patients discontinued treatment due to AEs during these extensions. Additionally, shifts to potentially significant laboratory values were considerably lower in patients exposed to at least two years of laquinimod (1.18% reached >3xULN ALT vs. 4.72% for laquinimod and 2.6% for placebo during the core study). The safety analysis included patients exposed to laquinimod 0.6 mg for two or more years (n=1009), with a mean exposure of 3.7 (±1.0) years, in the double-blind phase and open-label extensions of the Phase II LAQ/5063 and the Phase III ALLEGRO and BRAVO trials. "In this pooled analysis, laquinimod has shown to be safe for patients taking the treatment for two or more years, which supports the safety profile of laquinimod when used in a longer-term setting," said Professor Giancarlo Comi, Director of the Department of Neurology and Institute of Experimental Neurology at the San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Italy.
