Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Active Biotech (NASDAQ OMX NORDIC:ACTI) today announced the expansion of the laquinimod clinical development program with the initiation of the ARPEGGIO trial, which will evaluate the potential of laquinimod to treat primary progressive multiple sclerosis (PPMS). Additionally, Teva has screened the first patient in the LEGATO-HD trial, which will evaluate laquinimod in Huntington’s disease. Currently, there are no approved therapies available for the treatment of PPMS or the treatment of Huntington’s disease, beyond symptom management.
“Teva prides itself in striving to help patients with neurodegenerative diseases through research and innovation,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva Pharmaceutical Industries, Ltd. “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.”
The ARPEGGIO study will evaluate the efficacy, safety and tolerability of laquinimod in patients with PPMS with a primary endpoint of percent brain volume change (PBVC) through MRI analysis. PPMS is characterized by the worsening of neurologic function without distinct relapses (also called attacks or exacerbations). Approximately 15 percent of MS patients fall into the PPMS category.
The LEGATO-HD study will evaluate the efficacy, safety and tolerability of once-daily oral laquinimod as a potential treatment for adult patients with Huntington’s disease. The primary endpoint for LEGATO-HD is change from baseline in the Unified Huntington’s Disease Rating Scale-Total Motor Scale (UHDRS-TMS) as defined by the sum of the scores of all UHDRS-TMS sub-items after 12 months of treatment. Huntington’s disease is caused by a genetically-programmed degeneration of brain cells in select areas of the brain, which results in uncontrolled movements, loss of intellectual faculties and personality and emotional disturbances. Huntington’s disease affects about five to seven people per 100,000 in Western countries.
For further details on the Phase II ARPEGGIO and LEGATO-HD studies, please search laquinimod at ClinicalTrials.gov.