Investigational Cladribine Tablets Data Show Greater Treatment Effect in Relapsing MS Patients at a Higher Risk of Disease Progression

ROCKLAND, Mass., April 28, 2017 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, announced the presentation of new analyses of efficacy and safety data for investigational Cladribine Tablets in poster presentations at the Annual Meeting of the American Academy of Neurology (AAN), taking place April 22 – 28, 2017, in Boston, Massachusetts.

The findings from a retrospective subgroup analysis of the Phase III CLARITY trial in 289 patients with high disease activity* demonstrated statistically significant reduction in the risk of disability progression and relapse with Cladribine Tablets at a dose of 3.5mg/kg (n=140) compared with placebo (n=149) in relapsing multiple sclerosis (MS) patients who were either treatment naïve or had prior disease modifying drug (DMD) exposure.  

"We know that a proportion of patients with MS have a higher risk of relapse and disability progression than the broader population," said Prof. Gavin Giovannoni, a lead investigator in the CLARITY studies and Chair of Neurology, Barts and The London School of Medicine and Dentistry. "These data are important since they indicate that patients in the high disease activity subgroup treated with Cladribine Tablets showed a greater response than that seen in the overall CLARITY trial population."

The analysis demonstrated that treatment with Cladribine Tablets 3.5 mg/kg was associated with a larger reduction in the risk of 6-month confirmed EDSS progression in patients with high disease activity (82%; P=0.0001) than observed in the overall CLARITY population (47%; P=0.0016) vs placebo. Additionally, data showed that Cladribine Tablets reduced the relative risk of annualised relapse rate in patients with high disease activity (67%; P<0.0001) compared with the overall CLARITY population (58%; P=<0.0001). The study found that relapse and treatment history as well as MRI characteristics can help to identify patients who are at increased risk of experiencing relapses and disability progression.

"Cladribine Tablets is thought to selectively target the adaptive immune response in MS, and may be able to address a medical need in those patients already at higher risk of disability progression or relapses," said Luciano Rossetti, Head of Global R&D for the biopharma business of Merck KGaA, Darmstadt, Germany. 

A safety analysis of patients given Cladribine Tablets for 20 days over two years in either CLARITY or CLARITY Extension showed that, following the 10-day dosing period in treatment year 1, median lymphocyte counts were reduced to a low of 1.00×10⁹/L. However, by the end of treatment year 1 and 2, median lymphocyte counts had recovered to within the normal range. In the 2-year CLARITY study, the most commonly reported adverse event (AE) in patients treated with Cladribine Tablets was lymphopenia. The incidence of infections was 48.3% with Cladribine Tablets and 42.5% with placebo, with 99.1% and 99.0% respectively rated mild-to-moderate by investigators.

*Higher risk of disease progression and/or high disease activity is defined as patients with ≥ 1 relapse during the year prior to study entry while on DMD therapy AND ≥ 1 T1 Gd+ or ≥ 9 T2 lesions plus patients with ≥ 2 relapses during the year prior to study entry, regardless of prior use of DMD.

About Cladribine Tablets
Cladribine Tablets is an investigational short-course oral therapy that is thought to selectively and periodically target lymphocytes thought to be integral to the pathological process of MS. Cladribine Tablets is currently under clinical investigation and not yet approved for the treatment for any use in the United States, Canada and Europe. In July 2016, the European Medicines Agency (EMA) accepted for review the Marketing Authorisation Application (MAA) of Cladribine Tablets for the treatment of relapsing remitting multiple sclerosis. 

The clinical development program for Cladribine Tablets includes:

• CLARITY (CLAdRIbine Tablets Treating MS OrallY) study and its extension: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of Cladribine Tablets as a monotherapy in patients with RRMS and its two-year extension designed to provide data on the long-term safety and efficacy of extended administration of Cladribine Tablets for up to four years.
• ORACLE MS (ORAl CLadribine in Early MS) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of Cladribine Tablets as a monotherapy in patients at risk of developing MS (patients who have experienced a first clinical event suggestive of MS).
• ONWARD (Oral Cladribine Added ON To Interferon beta-1a in Patients with Active Relapsing Disease) study: a Phase II placebo-controlled study designed primarily to evaluate the safety and tolerability of adding Cladribine Tablets treatment to patients with relapsing forms of MS, who have experienced breakthrough disease while on established interferon-beta therapy.
• PREMIERE (Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients Who Have Participated in Cladribine Clinical Studies) study: interim long-term follow-up data from the prospective registry, PREMIERE, to evaluate the safety and efficacy of Cladribine Tablets. The follow-up will consist of over 10,000 patient years of exposure in total, with follow-up in some patients exceeding eight years at completion.

About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.3 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

About EMD Serono, Inc.
EMD Serono is the North America biopharma business of Merck KGaA, Darmstadt, Germany - a leading science and technology company - focused exclusively on specialty care. For more than 40 years, the business has integrated cutting-edge science, innovative products and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in oncology, immuno-oncology and immunology as R&D focus areas. Today, the business has more than 1,100 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts.

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