Laquinimod's promise as an add-on neuroprotective therapy is now in question. #NewsSpeak #MSBlog
The news that the third RRMS trial of laquinimod did not reach its primary endpoint is bad news. People with MS were hoping to benefit in the future from laquinimod as an-add neuroprotective therapy.
Press release: Teva and Active Biotech Announce CONCERTO trial of Laquinimod in RRMS Did Not Meet Primary Endpoint. 5th May 2017.
Teva and Active Biotech 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).
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.