Teva Pharmaceutical Industries Ltd. and Active Biotech 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) There are no approved therapies available for the treatment of PPMS 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 the study.”
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 characterised 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 study, A Randomized Placebo-controlled Trial Evaluating Laquinimod in PPMS, Gauging Gradations In MRI and Clinical Outcomes (ARPEGGIO) is a multinational, multicenter, randomised, double-blind, parallel-group, placebo-controlled, Phase II clinical trial.
ARPEGGIO is intended to serve as a proof-of-concept study for potential treatment with laquinimod in PPMS. The trial will evaluate two doses of laquinimod (0.6 and 1.5mg/day) in PPMS compared to placebo. The primary endpoint of the study is brain atrophy as defined by PBVC from baseline to week 48. Secondary endpoints include time to confirmed disability progression, the number of new T2 lesions and change in the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) score. ARPEGGIO has an estimated completion date of H2 2017.
Source: Finances © 2014 Finances International Ltd (04/11/14)