Drug manufacturers Teva Pharmaceutical Industries Ltd. and Active Biotech announced that they expanding the ongoing clinical research program for the study of laquinimod, a potential treatment for primary progressive multiple sclerosis (PPMS), as the companies are now initiating the ARPEGGIO trial. In addition, Teva has also announced the screening of the first patient within the LEGATO-HD trial, that is studying the same drug in patients with Huntington’s disease.
Laquinimod is an investigational CNS-active immunomodulator that is administrated orally once a day and is believed to be safe and effective for the treatment of relapsing-remitting MS (RRMS), progressive MS, and Huntington’s disease. The drug is being evaluated in two pivotal studies, which are part of the company’s global phase III clinical program. The news is particularly relevant, since there are currently no approved therapies for these therapies, besides medication designed to managing the symptoms.
“Teva prides itself in striving to help patients with neurodegenerative diseases through research and innovation,” stated the President of Global R&D and Chief Scientific Officer at Teva Pharmaceutical Industries, Ltd., Michael Hayden, M.D., Ph.D. “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.”
ARPEGGIO, or A Randomized Placebo-controlled Trial Evaluating Laquinimod in PPMS, Gauging Gradations In MRI and Clinical Outcomes, is a study designed to assess the efficacy, safety, and tolerability of laquinimod being conducted with PPMS patients with a primary endpoint of measuring brain atrophy, defined by percent brain volume change (PBVC), which is a symptom found in 15% of MS patients. The diseases cause worsening of neurologic function, even though the patients experience no exacerbations.
Being a multinational and multicenter phase II clinical trial, researchers working on ARPEGGIO are also examining a parallel-group in a randomized, double-blind and placebo-controlled study to compare the results with the patients being administrated with 0.6 or 1.5mg per day of laquinimod. The completion of the study is planned for the second half of 2017.
Last May, the two companies received discouraging news from the European Union, as the Committee for Medicinal Products for Human Use announced that they did not recommend the use of laquinimod for the treatment of RRMS by the countries within the union. Despite the news, the companies decided to continue their development work, and most recently, Teva and Active Biotech presented follow-up data evaluating the clinical safety of the drug from their phase II, phase III, and open-label extension studies, at the 30th Congress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS) in Boston.
Another key study, LEGATO-HD, which stands for Laquinimod Efficacy and Safety in a GlobAl Trial Of HD, aims to study the efficacy, safety, and tolerability of once-daily oral laquinimod, as treatment for adult patients suffering from Huntington’s disease. In addition, the trial has as primary endpoint of studying the change from baseline in the Unified Huntington’s Disease Rating Scale-Total Motor Scale (UHDRS-TMS), which is determined by the sum of the scores of all UHDRS-TMS sub-items after 12 months of receiving laquinimod.