Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Active Biotech
(NASDAQ OMX NORDIC: ACTI) provided today an update on the clinical
development program of once-daily oral laquinimod for the treatment of
relapsing-remitting multiple sclerosis (RRMS). The companies are to
initiate a third Phase III study of laquinimod, following the written
agreement reached with the U.S. Food and Drug Administration (FDA) on
the Special Protocol Assessment (SPA).
The third Phase III laquinimod trial CONCERTO will evaluate two doses of
the investigational product (0.6mg and 1.2mg) in approximately 1,800
patients for up to 24 months. The primary outcome measure will be
confirmed disability progression as measured by the Expanded Disability
Status Scale (EDSS).
"The results achieved in the previous Phase III trials of laquinimod
support the clinical utility of this compound as a unique treatment
option for multiple sclerosis," said Dr. Michael Hayden, President of
Global R&D and Chief Scientific Officer, Teva Pharmaceutical Industries
Ltd. "We are encouraged by the FDA's agreement on the trial design and
planned analysis, and look forward to further developing laquinimod as a
potential treatment option for RRMS patients."
Teva Pharmaceutical Industries Ltd.