Teva Pharmaceutical Industries Ltd, a leading global pharmaceutical company and Active Biotech, a biotechnology company, have announced results from the CONCERTO trial in 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).

Other data details announced by the Company show that on 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). Other encouraging results were seen on the secondary endpoint of time to first relapse (risk reduced by 28%; p = 0.0001) and 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).

“We have learned a great deal from the CONCERTO trial and we will continue our analysis of the data,” said Michael Hayden, M.D., Ph.D., president of global r&d and chief scientific officer at Teva. “Although we are disappointed by not meeting the primary endpoint, we did see positive results on a number of secondary and exploratory endpoints which fuels our belief in the potential of laquinimod as a possible treatment for neurodegenerative diseases. While we have no current plans to further pursue laquinimod in RRMS, we are continuing to study it in two other trials.”

The clinical safety profile of laquinimod 0.6 mg daily, which had been previously studied with over 12,000 patient-years of exposure, was confirmed in CONCERTO. Adverse events reported in 5% or more of CONCERTO patients taking 0.6 mg daily of laquinimod were headache (17%), nasopharyngitis (9%), back pain (7%), and arthralgia (5%).

Teva continues to evaluate the potential of laquinimod in primary progressive MS (PPMS) and Huntington disease (HD) with two other clinical trials unaffected by the results of the CONCERTO trial. Complete data from the CONCERTO trial will be published in a scientific journal and presented at a future medical meeting.

CONCERTO is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with RRMS. The higher-dose (1.2 mg) arm of the trial was discontinued in January 2016. In addition to the primary outcome measure of time to CDP after at least 3 months as measured by change in EDSS, CONCERTO examined the impact of laquinimod (0.6 mg) on the secondary endpoints of change in brain volume from baseline to month 15, time to first confirmed relapse and CDP measured by EDSS after at least 6 and 9 months—all secondary endpoints as compared to placebo.

Laquinimod is a once-daily oral, investigational, selective aryl hydrocarbon receptor (AhR) activator targeting neurodegeneration and inflammation with a novel mechanism of action being developed for the treatment of relapsing -remitting MS (RRMS), primary-progressive MS (PPMS) and Huntington disease.