EMD Serono to Present Data Highlighting Investigational Cladribine Tablets at CMSC 2017

ROCKLAND, Mass., May 25, 2017 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, today announced 14 presentations, including eight sets of data on Cladribine Tablets, an investigational, oral, small molecule being developed for the treatment of relapsing multiple sclerosis (MS) at the 31st Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC), taking place from May 24-27, 2017, in New Orleans, LA.

"Our ongoing research underscores the company's commitment to developing new therapeutic options for patients with MS," said Dr. Joseph Leveque, Chief Medical Officer, EMD Serono. "Data presented at CMSC add to the body of research evaluating the efficacy and safety of Cladribine Tablets as a potential treatment option for patients with relapsing MS."

An oral presentation includes an assessment of the duration of clinical outcome response to Cladribine Tablets from the CLARITY and CLARITY EXTENSION studies.¹ The data demonstrate a statistically significant reduction in the annualized relapse rate at 96 weeks in both Cladribine Tablets groups, as compared with the placebo group (0.14 in the Cladribine Tablets 3.5-mg/kg group and 0.15 in the Cladribine Tablets 5.25-mg/kg group, vs 0.33 in the placebo group), for relative reductions of 57.6% and 54.5%, respectively (p<0.001 for both comparisons). Additionally, the proportion of patients with no new T1 Gd+ lesions was 73.0% to 89.9% respectively for the treatment groups (in CLARITY EXTENSION).

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.

In CLARITY, patients were randomized to receive either Cladribine Tablets (3.5 or 5.25mg/kg) or placebo over two years. In the two-year extension, patients who received placebo in the double-blind phase, were re-randomized to receive Cladribine Tablets (3.5mg/kg). Patients who received Cladribine Tablets at either dose in the double-blind phase were re-randomized 2:1 to Cladribine Tablets 3.5mg/kg or placebo for years 3 and 4.

"We compared the results from two 2-year studies to further understand the duration of efficacy of Cladribine Tablets," said Dr. Kottil Rammohan, an investigator in the CLARITY studies and Professor of Neurology – Clinical, and the Director of the Multiple Sclerosis Center at the University of Miami. "It's important that we saw similar results replicated in the CLARITY EXTENSION trial, which further supports the overall efficacy profile of Cladribine Tablets. Rates of clinical and MRI disease activity-free status were consistent with Cladribine Tablets across all subsets of MS patients for the duration in both trials."

Additionally, a separate study, the ORACLE-MS study, investigated the effect of Cladribine Tablets 3.5 mg/kg of bodyweight or 5.25 mg/kg on conversion to clinically definite multiple sclerosis. Data showed that annualized relapse rates in the open-label period were lower in patients originally randomized to receive either dose of Cladribine Tablets compared with placebo (0.14 in the Cladribine Tablets 3.5-mg/kg group and 0.24 in the Cladribine Tablets 5.25-mg/kg group, vs. 0.42 in the placebo group.²

In the ORACLE-MS study, the most commonly reported AE in patients treated with Cladribine Tablets was lymphopenia. The incidence of infections was 8.3% in patients previously exposed to Cladribine Tablets 5.25/mg/kg, 4.0% in patients previously exposed to Cladribine Tablets 3.5 mg/kg, and 3.3% in patients previously exposed to placebo.

Cladribine Tablets is currently under clinical investigation and not yet approved for the treatment for any use in the United States, Canada, Europe or elsewhere.

I'm Facing MS: Interactive Booth
EMD Serono has an interactive and innovative medical booth at CMSC. Attendees can learn more about EMD Serono's programs, pipeline and activities in neurology by visiting booth #701. EMD Serono has created an interactive experience for attendees, I'M Facing MS, which simulates changes in balance, fatigue, and vision that patients with MS experience. For every participant in the I'M Facing MS activity, EMD Serono will give a donation to the CMSC Foundation. On Thursday, May 25 at 5 p.m. CT we will present a $10,000 donation to the CMSC Foundation.

Teamworks Program: A Virtual Team Addressing Patient Inquiries
The CMSC, with support from EMD Serono, will launch an educational video series at this year's annual meeting. The videos are multi-purpose and are designed help the MS community prepare for doctor's appointments, gain knowledge when they are in between appointments, or aid physicians in providing education to their patients. The series will feature answers to patients' common questions and concerns, surrounding topics such as the symptoms that they are experiencing.

The following abstracts were accepted for presentation at the CSMC 2017 Annual Meeting:

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 Rebif® (interferon beta-1a)
Rebif (interferon beta-1a) is used to treat relapsing forms of MS to decrease the frequency of relapses and delay the occurrence of some of the physical disability that is common in people with MS. The efficacy and safety of Rebif in controlled clinical trials beyond 2-years has not been established.

Important Safety Information
Rebif is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin, or any other component of the formulation.
Rebif should be used with caution in patients with depression, a condition that is common in people with multiple sclerosis. Depression, suicidal ideation, and suicide attempts have been reported to occur with increased frequency in patients receiving interferon compounds, including Rebif.

Severe liver injury, including some cases of hepatic failure requiring liver transplantation, has been reported rarely in patients taking Rebif. The potential for liver injury should be considered when used in combination with other products associated with liver injury.  Monitor liver function tests and patients for signs and symptoms of hepatic injury.  Consider discontinuing Rebif if hepatic injury occurs.

Anaphylaxis and other allergic reactions (some severe) have been reported as a rare complication of Rebif. Discontinue Rebif if anaphylaxis occurs.

In controlled clinical trials, injection site reactions occurred more frequently in Rebif-treated patients than in placebo-treated and Avonex-treated patients. Injection site reactions including injection site pain, erythema, edema, cellulitis, abscess, and necrosis have been reported in the postmarketing setting. Do not administer Rebif into affected area until fully healed; if multiple lesions occur, discontinue Rebif until skin lesions are healed.

Decreased peripheral blood counts in all cell lines, including pancytopenia, have been reported in Rebif-treated patients. In controlled clinical trials, leukopenia occurred at a higher frequency in Rebif-treated patients than in placebo and Avonex-treated patients. Thrombocytopenia and anemia occurred more frequently in 44 mcg Rebif-treated patients than in placebo-treated patients. Patients should be monitored for symptoms or signs of decreased blood counts. Monitoring of complete blood and differential white blood cell counts is also recommended.

Cases of thrombotic microangiopathy (TMA), some fatal, have been reported with interferon beta products, including Rebif, up to several weeks or years after starting therapy. Discontinue Rebif if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated.

Caution should be exercised when administering Rebif to patients with pre-existing seizure disorders. Seizures have been temporally associated with the use of beta interferons, including Rebif, in clinical trials and in postmarketing reports.

The most common side effects with Rebif are injection-site disorders, headaches, influenza-like symptoms, abdominal pain, depression, elevated liver enzymes, and hematologic abnormalities.
There are no adequate and well-controlled studies in pregnant women. Rebif should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Rebif full prescribing information is available at http://www.emdserono.com/ms.country.us/en/images/Rebif_PI_tcm115_140051.pdf?Version=

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.

www.emdserono.com

¹ Giovannoni G, et al. Benefits of Cladribine Tablets in patients with multiple sclerosis free from clinical and radiological indicators of disease activity in the CLARITY Extension study. Consortium of Multiple Sclerosis Centers. May 26, 2017; New Orleans, Louisiana.

² Comi G, et al. Cladribine Tablets in the ORACLE-MS study open-label maintenance period: analysis of efficacy in patients after conversion to clinically definite multiple sclerosis (CDMS). Consortium of Multiple Sclerosis Centers. May 25, 2017; New Orleans, Louisiana.

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