- Israeli drugmaker Teva Pharmaceutical Industries suffered another setback in its search for a blockbuster drug. The company announced Tuesday that Phase 2 testing of laquinimod for treating Huntington's disease failed to meet its primary efficacy endpoint.
- Laquinimod failed to show statistical improvement for patients with Huntington's after a year of treatment, as measured by the Unified Huntington's Disease Rating Scale measuring total motor score.
- The study did meet a secondary endpoint of reducing brain atrophy, which reiterates a result from an earlier clinical trial for relapsing-remitting multiple sclerosis.
The generic giant remains in search of a follow-up to its best-selling drug, Copaxone (latiramer), which hit the patent cliff in recent years with the launch of generic versions from Novartis and Mylan.
The Phase 2 trial, called LEGATO-HD, studied 352 patients and evaluated three levels of dosing: 0.5 mg, 1.0 mg and 1.5 mg. The 1.5 mg was prematurely terminated as a precaution in January 2016 after trials testing the drug for MS raised cardiovascular safety concerns for 1.2 mg and 1.5 mg doses.
The study was sponsored by Teva in collaboration with the Huntington Study Group and the European Huntington's Disease Network. Further results from the study were not released, and Teva said in a statement it will submit study results for presentations at future medical meetings and publication in peer-reviewed journals.
Laquinimod is an oral, immunomodulatory drug focused on neurodegeneration and related diseases.
The failure of laquinimod in treating Huntington's is sure to disappoint but is not too surprising, as the drug previously struck out in treating both primary progressive and relapsing-remitting MS. Its development for MS treatment was discontinued after those failures.
Teva has held the commercialization and development rights for the drug since 2004, through an agreement with Active Biotech, a small firm based in Lund, Sweden.
While Teva's stock remained essentially flat Tuesday morning, Active Biotech took a dive on the Nasdaq Stockholm, shedding roughly one-third of it share price.