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Teva, Active Biotech complete patient enrollment in phase 3 clinical trial for MS treatment

6/25/2009

JERUSALEM Two drug makers announced Thursday that they have finished enrolling patients in a phase 3 clinical trial to evaluate a drug for treating relapsing-remitting multiple sclerosis.

Teva Pharmaceutical Industries and Active Biotech said the trial would compare the drug, laquinimod, with placebo and with Biogen Idec’s injectable treatment Avonex (interferon beta-1a). Laquinimod is designed as a once-daily oral treatment for RRMS. The trial involves 1,200 patients at 156 sites in the United States, Europe, Israel and South Africa.

“Teva and Active Biotech are encouraged by the potential of laquinimod to address patients’ unmet need for an oral immunomodulating MS therapy that provides efficacy while maintaining safety,” Teva group VP global branded products Moshe Manor said in a statement. “We look forward to continuing our clinical phase 3 program of laquinimod and hope it will offer enhanced quality of health for RRMS patients.”

The trial, called BRAVO, accompanies the phase 3 ALLEGRO study, which finished enrolling more than 1,000 patients at 152 sites in North America, Asia and Europe in November and is ongoing. The Food and Drug Administration gave laquinimod fast-track designation in February.

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