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news.Teva Pharmaceutical Industries and Active Biotech will initiate third Phase III study of Oral Laquinimod for the treatment of relapsing remitting multiple sclerosis.
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The companies are to initiate a third Phase III study of laquinimod, following the written agreement reached with the FDA on the Special Protocol Assessment.
Teva Pharmaceutical Industries chief scientific officer and Global R&D president Michael Hayden said the results achieved in the previous Phase III trials of laquinimod support the clinical utility of the compound as a unique treatment option for multiple sclerosis.
"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," Hayden added.
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).