Cladribine Demonstrates Disease Control with Shorter-Course Treatment

Phase III study extension proves two annual short courses for multiple sclerosis drug is as effective as a four-year treatment.

Merck’s biopharmaceutical business, EMD Serono, Inc., released the results from the company’s CLARITY Phase III extension study, which demonstrated that Cladribine Tablets, administered in two annually administered courses was as effective as patients taking four courses over four years, in patients with relapsing/remitting multiple sclerosis (RRMS).

The CLARITY extension, according to the release, included 806 patients from the first 1,184 patients who completed the original CLARITY study. The extension study assessed several clinical efficacy endpoints including annualized relapse rate (ARR) and confirmed 3-month Expanded Disability Status Scale (EDSS) progression. According to EMD Serono, the proportion of patients who remained relapse free at the end of four years was “similar” to patients receiving 3.5 mg/kg Cladribine Tablets in the first CLARITY study followed by placebo.

"Today's publication further strengthens the evidence for the use of Cladribine Tablets in MS, said Gavin Giovannoni, a Lead Investigator in the CLARITY studies and Chair of Neurology, Barts and The London School of Medicine and Dentistry. “Demonstrating significant, durable benefits in patients not receiving active treatment after the two short courses," said Giovannoni, "the data from this publication and other recent articles suggest that Cladribine Tablets selectively targets the adaptive immune system, particularly the b cell compartment, and therefore allows the immune system to reconstitute while still preventing MS disease activity in the majority of treated patients."

An investigational short-course therapy, Cladribine Tablets selectively and periodically targets lymphocytes, which the company explains is thought to be integral to the pathological process of RRMS. EMD Soreno said Cladribine Tablets are under clinical investigation and have not been approved for treatment or use in the U.S. or Canada. However, in August the EC granted authorization for Cladribine Tablets to be marketed as Mavenclad in the European Union.

 

Guy Tiene

Guy supports the success of life science organizations by identifying synergies across research, content, marketing and communications resources to drive value for clients. With over 30 years of education and marketing experience and 18 years in the life sciences alone, Guy leads our editorial standards for client content, Pharma’s Almanac and Nice Insight research-based industry content as well as external communications for clients. Having served as head of global marketing and communications for a CMO, he also brings critical insight and guidance to all communications. Guy holds a Masters degree from Columbia University.

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