Teva and Active Biotech Announce results of CONCERTO trial Did Not Meet Primary Endpoint

Teva Pharmaceutical and Active Biotech announced that the results from the CONCERTO trial did not meet primary endpoint. The trial was based on patients with relapsing-remitting multiple sclerosis (RRMS).

The primary endpoint in CONCERTO — the evaluation of laquinimod (0.6 mg/daily capsules) versus placebo to evaluate the time to Confirmed Disability Progression (CDP) after at least 3 months – was not met. (Hazard Ratio of 0.937, p = 0.7057). Whereas the secondary endpoint which measured change in brain volume– an indicator of disability progression over time– compared to baseline was positive (40% improvement over placebo at month 15, p < 0.0001). The exploratory endpoint of annualized relapse rate (risk reduced by 25%; p=0.0001). As with the primary endpoint, secondary endpoints measuring time to CDP at 6 and 9 months did not reach significance. On the exploratory endpoint of reduction of the number of gadolinium-enhancing T1 lesions at month 15, laquinimod demonstrated a 30% reduction (p=0.004).

Teva President of Global R&D and Chief Scientific Officer, Michael Hayden said that they have learned a great deal from the CONCERTO trial and they will continue their analysis of the data. Although they are disappointed by not meeting the primary endpoint, they did see positive results on a number of secondary and exploratory endpoints which fuels their belief in the potential of laquinimod as a possible treatment for neurodegenerative diseases. While they have no current plans to further pursue laquinimod in RRMS, they are continuing to study it in two other trials.