The FINANCIAL — Teva Pharmaceutical Industries Ltd. and Active Biotech on June 25 announced that the patient enrollment for the pivotal Phase III CONCERTO trial has been finalized, as well as a planned sample size re-assessment analysis of the study. CONCERTO, the third Phase III trial of laquinimod in patients with relapsing-remitting multiple sclerosis (RRMS), is designed to evaluate the safety and efficacy of laquinimod (0.6mg or 1.2mg/day) with a primary endpoint of time to Confirmed Disability Progression (CDP), as measured by the Expanded Disability Status Scale (EDSS).
The sample size reassessment was included as part of the protocol to confirm that the original assumptions are in line with the study and that the sample size is adequate. Based on recent agreement with FDA, under a Special Protocol Assessment (SPA) agreement, study completion will occur when either 260 events are reached or all patients complete 24 months of study treatment (whichever occurs first). CONCERTO study results are expected to be available toward mid-2017. Regulatory submission will follow study completion, according to Teva.
“We are committed to realizing the full potential of laquinimod. The molecule has a unique mechanism for future treatment of MS and other neurodegenerative diseases by working directly in the Central Nervous System, showing promise to prevent brain atrophy and slow disability progression in these patients,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva.
Laquinimod is also being tested in Phase II trials for the treatment of subjects with primary progressive MS and Huntington disease; two diseases for which no approved disease modifying therapies are available.