Merck Serono’s Phase III CLARITY trial of its oral formulation of cladribine met the two-year primary endpoint of clinical relapse rate reduction in patients with relapsing-remitting multiple sclerosis (MS).
     
The two cladribine tablet treatment groups of the study, assessing different doses, demonstrated a statistically significant reduction in the annualized rate of relapses compared to placebo. Patients from the lower total dose group experienced a 58% relative reduction compared to placebo and patients from the higher dose group experienced a 55% relative reduction compared to placebo. Secondary endpoints of the study were also met, including reduction of lesion activity as measured by magnetic resonance imaging (MRI), proportion of subjects relapse-free and disability progression. The frequencies of adverse events were low in the cladribine tablet treatment groups and were comparable to those observed in the placebo group.

“We believe the CLARITY data mark an important milestone in the assessment of investigational oral treatments for multiple sclerosis and that cladribine tablets have the potential to make a real difference in the lives of patients,” said Elmar Schnee, president of Merck Serono. “Based on the successful completion of the study, we plan to submit cladribine tablets for registration to the EMEA and to the FDA for mid-2009.”