Teva, Active Biotech Expand Laquinimod Program In Neurodegenerative Diseases
By Cyndi Root
Teva Pharmaceutical Industries and Active Biotech have expanded their partnership with new trials of laquinimod. The companies announced the move in a press release, stating that the ARPEGGIO trial will evaluate laquinimod in primary progressive multiple sclerosis (PPMS), and the LEGATO-HD trial will evaluate laquinimod in Huntington’s disease, neither of which have any approved therapies available, except for symptom management.
Michael Hayden, M.D., Ph.D., President of Global R&D and CSO at Teva, said, “Laquinimod has been shown to modulate several significant pathways common to key neurodegenerative disease. More specifically, it modulates the immune cell lineages in the periphery and in the CNS. We look forward to the results from both of these studies.”
Laquinimod
Laquinimod is Active Biotech’ s orally administered small molecule. The agent has immunomodulatory properties with a novel mechanism of action. In January 2014, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave a negative opinion regarding Laquinimod (brand name Nerventra) for relapsing-remitting multiple sclerosis (RRMS). Teva and Active Biotech have requested a re-examination of the CHMP opinion.
ARPEGGIO Study
The ARPEGGIO study will evaluate laquinimod in patients with PPMS. Investigators will measure the percent of brain volume change (PBVC) through MRI analysis. The multicenter Phase 2 trial is a placebo-controlled, proof-of-concept study evaluating two doses of laquinimod (0.6 and 1.5mg/day) compared to a placebo. PBVC measurements from baseline to week 48 will track brain atrophy and serve as the primary endpoint of the trial. The secondary endpoints include confirmed disability progression, the number of new T2 lesions, and the change in the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) score. Teva and Active Biotech expect to complete the study by 2017.
LEGATO-HD Study
The LEGATO-HD study will evaluate laquinimod in adult patients with Huntington’s disease. The primary endpoint is the change from baseline in the Unified Huntington’s Disease Rating Scale-Total Motor Scale (UHDRS-TMS) after 12 months of treatment. The placebo-controlled trial will evaluate the efficacy and safety of three doses of laquinimod (0.5, 1.0, and 1.5 mg/day). The Phase 2 trial expects 400 patients between the ages of 21-55. Investigators will also carry out studies of microglia activation, neuronal integrity, and peripheral inflammatory biomarkers. The two companies expect to complete the study in 2017.