The results of the CONCERTO trial of laquinimod by Teva Pharmaceutical Industries Ltd (NYSE:TEVA) and Active Biotech have not met their endpoint. The trial was primarily evaluating the drug in patients with relapsing-remitting multiple sclerosis (RRMS). The drug, which was seeking Confirmed Disability Progression (CDP) for at least three months, was in comparison with placebo.

Nonetheless, there was still something to hang on. The secondary endpoint, which was measuring the change in the brain, had a 40% improvement in comparison to placebo. The results on the secondary endpoint of time to first relapse did not disappoint either as the exploratory endpoint of annualized relapse rate.

Teva and Active Biotech cease to give high doses of laquinimod

Laquinimod, which is a 0.6 mg daily oral administration, had previously been studied with over 12,000 patient-years of exposure. Its clinical safety profile was confirmed in CONCERTO with very few adverse events the likes of headaches and back pain. However, the two companies had earlier stated their intention of ceasing to administer high doses of laquinimod. This was as a result of non-fatal cardiac cases that were reported in two studies of multiple sclerosis.

Nonetheless, the two companies will carry on with their analysis according to President of Global R&D and Chief Scientific Officer at Teva, Michael Hayden. He says, “Although we are disappointed by not meeting the primary endpoint, we did see positive results on a number of secondary and exploratory endpoints……..we are continuing to study it in two other trials.”

Let’s explore CONCERTO

The parallel group, placebo-controlled study involves the evaluation of efficacy safety and tolerability of two oral doses of laquinimod for an active treatment period. This runs for at least 3 months and in subjects with RRMS. More often than not, its evaluation is usually in comparison to placebo.

Teva’s healthcare solutions are spread out in over 100 markets. They are used by close to 200 million patients; thanks to the broad portfolio of more than 1,800 molecules of generic products. In the meantime, Teva’s stock at trading at $31.14 witnessing an increase of $0.27 or 0.87%