Merck Serono, Germany, announced new data from a post-hoc analysis of the two-year (96-week) placebo-controlled CLARITY1 phase III trial using a short-course of Cladribine Tablets (Merck Serono’s proprietary investigational oral formulation of cladribine) to treat patients with relapsing-remitting multiple sclerosis (MS).
The data from this post-hoc analysis of the CLARITY study were presented at the 25th congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Dusseldorf, Germany.
These data show that over two years of study, 43% and 44% of patients treated with Cladribine Tablets (total dose of 3.5 mg/kg and 5.25 mg/kg respectively) had absence of disease activity, compared with 16% of patients who received placebo.
Disease activity was assessed both clinically and radiologically and absence of disease activity was stringently defined as no relapses, no sustained disability progression, no T1 gadolinium-enhancing lesions and no active T2 lesions based on magnetic resonance imaging (MRI) during the study.
“Immune-mediated disorders such as relapsing forms of multiple sclerosis are characterised by periods of disease activity alternating with periods of remission, and a very important goal in treating such disorders is to help patients achieve and maintain disease remission for longer periods of time”, said Dr Peter Rieckmann, Professor of Neurology, Director Department of Neurology, Bamberg Hospital, Germany, UBC Research Chair Vancouver, Canada, and an investigator in the CLARITY study.
“This CLARITY data analysis is very encouraging, based on the comparison between short-course oral treatment with Cladribine Tablets and placebo with respect to MS patients who had no disease activity, as assessed by both clinical and radiological measures over two years, with only 8-20 days of treatment in the first year of study and only 8-10 days of treatment in the second year of study.”
Merck Serono submitted a marketing authorization application to the European Medicines Agency (EMEA) for Cladribine Tablets in July 2009 and will submit further registration applications for Cladribine Tablets in other countries, including the United States, during Q3 2009.