Teva dropping Phase III laquinimod trial

Active Biotech AB (SSE:ACTI) said Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) is discontinuing the Phase III LIBRETTO trial, which was slated to compare daily oral laquinimod to weekly intramuscular Avonex interferon beta-1a from Biogen Idec Inc. (NASDAQ:BIIB) to treat relapsing-remitting multiple sclerosis (RRMS). Active Biotech said the trial's design is "no longer aligned with the regulatory strategy" for laquinimod, but the partners could not be reached for details. The company said the decision has no impact on other ongoing laquinimod studies, including the Phase III CONCERTO trial, for which the partners have an SPA from FDA.

Last month, EMA's CHMP recommended against approval of laquinimod because the benefits of the oral quinoline-3-carboxamide immunomodulator in RRMS patients do not outweigh the potential risks. Teva and Active Biotech said they plan to request a reexamination (see BioCentury Extra, Jan. 24). ...