Post Hoc Clinical Trials Data for Cladribine, An Investigational Oral Multiple Sclerosis Treatment

Thursday, February 01, 2018

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, announced that new clinical trial data is being released during the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) meeting February 1-3, 2018. The results evaluate safety of cladribine tablets and the effect of cladribine on the immune system via post hoc analyses of 3 clinical trials, a phase 2 clinical trial, and a registry study.

In the U. S., cladribine is currently under clinical investigation and not yet approved for any use. EMD Serono recently announced it will file a regulatory submission for cladribine tablets with the Food and Drug Administration in the second quarter of 2018. In the European Union and Canada, cladribine was approved in 2017 for treatment of highly active relapsing forms of multiple sclerosis (MS) as defined by imaging or clinical features of a patient’s illness. The drug is marketed as MAVENCLAD in these regions.

"We are proud to share further clinical trial data during ACTRIMS 2018 evaluating the use of cladribine tablets in patients with multiple sclerosis. This adds to the body of research to help best understand the role of cladribine tablets as a potential future treatment option for appropriate patients who live with MS," said John Walsh, M.D., Vice President, Neurology & Immunology, US Medical Affairs at EMD Serono. "Our ongoing research underscores our commitment to developing new therapeutic options for patients with chronic and hard-to-treat conditions like MS."

Cladribine is thought to selectively and periodically target lymphocytes that are involved in the pathological process of relapsing MS (RMS). The new data presented in 6 posters at ACTRIMS, includes information regarding the effect of cladribine on: lymphocyte surface marker CD4+; B-cell, T-cell, and NK-cell counts; rates of lymphopenia during treatment; and rates of infection during periods of lymphopenia (Stuve O. ACTRIMS 2018: Poster Nos. 59 & 60, Cook S. ACTRIMS 2018: Poster Nos. 70 & 86, Soelberg-Sorensen P. ACTRIMS 2018: Poster Nos. 061 & 84).

The results come from post hoc analyses of 3 phase 3 clinical trials: the Cladribine Tablets Treating MS Orally (CLARITY), the CLARITY-extension trial, the Oral Cladribine in Early MS (ORACLE MS) study; a phase 2 clinical study, Oral Cladribine Added on to Interferon ß-1a in Patients with Active Relapsing Disease (ONWARD), and a prospective registry study, Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients Who Have Participated in Cladribine Clinical Studies (PREMIERE). The PREMIERE study includes data from over 2,700 patients involved in the clinical trials and represents more than 10 years of observation for some patients and over 10,000 patient years total.

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