Teva Pharmaceutical Industries Ltd. and Active Biotech have discontinued the use of higher doses of the drug laquinimod in two ongoing multiple sclerosis (MS) studies. The decision was based on a recommendation by the Data Monitoring Committee (DMC) that is supervising the clinical trials after cardiovascular events, none of which were fatal, were reported in eight patients.
The DMC identified an imbalance in the number of cardiovascular events being reported, according to a press release. Seven of the events were detected in patients receiving 1.2 mg of laquinimod every day for the treatment of relapsing-remitting MS (RRMS) in the CONCERTO clinical trial, which has 2,199 patients enrolled. No events were observed in the 0.6 mg laquinimod or placebo patient groups in this Phase 3 study.
The eighth cardiovascular event was reported in the 1.5 mg daily-dose arm of the ARPEGGIO clinical trial assessing laquinimod in primary progressive MS (PPMS). In total, the Phase 2 ARPEGGIO trial has 191 patients currently enrolled.
Teva is notifying all sites in both trials to stop the administration of laquinimod at higher doses, and encouraging participants to continue the follow-up part of the studies. Laquinimod is a once-daily oral, CNS-active immunomodulator with a novel mechanism of action being developed as a possible treatment for relapsing-remitting MS, primary-progressive MS, and Huntington’s disease.
The DMC did not identify cardiovascular events at the lower laquinimod dose, but recommends long-term monitoring. Both the CONCERTO and ARPEGGIO trials will continue the lower-dose arms (0.6 mg a day) and all participants will be given an update to confirm participation re-consent.
Teva has completed large trials and is currently doing long-term extension studies at the 0.6 mg dose level without cardiovascular concerns.
Teva, headquartered in Israel, is a leading global pharmaceutical company developing innovative treatments for disorders affecting the central nervous and the respiratory systems. The company, though a licensing agreement, has global rights to develop and market laquinimod, discovered by Active Biotech.