Teva Pharmaceutical ($TEVA) is rolling its troubled CNS drug laquinimod into a mid-stage study in Huntington's disease, looking to expand the potential of a treatment marked by clinical and regulatory setbacks.
Active Biotech, Teva's partner on the drug, said the company is setting out to test its oral medication on patients with Huntington's, an inherited neurodegenerative ailment that affects about one in every 10,000 Americans. Teva plans to kick off its study next month, enrolling about 400 patients to chart whether three doses of laquinimod can improve disease scores and motor function compared to placebo.
Meanwhile, the company is still toiling on laquinimod's primary indication: relapsing-remitting multiple sclerosis. The drug has long been tabbed as the successor to Teva's $4 billion-a-year MS treatment Copaxone, which comes off patent next year, but things haven't quite gone according to plan.
In May, Europe's Committee for Medicinal Products for Human Use (CHMP) declined to recommend laquinimod for approval, confirming a negative opinion handed down in January. In its first rejection, CHMP pointed to safety risks that cropped up in animal studies and weren't dispelled by later human trials, noting that exposure to laquinimod was tied to a higher occurrence of cancer and some dangers for pregnant women. On the efficacy side, the committee was satisfied with the treatment's ability to slow the progression of MS-related disability but unimpressed with its effect on relapses.
Laquinimod has endured two Phase III missteps on its way to regulatory uncertainty, repeatedly failing to significantly reduce relapse rates in MS patients. Teva is now in the midst of a third late-stage trial, dubbed CONCERTO, studying the treatment's effects on disability progression. Data from that study will likely support Teva's second go at EU approval, and the company has said it expects to win an FDA nod by 2018.
The drug, to be marketed as Nerventra, has also completed Phase II studies in lupus and Crohn's disease.
- read the statement (PDF)
- here's the ClinicalTrials.gov entry