DARMSTADT, Germany, June 26, 2017 /PRNewswire/ --
- Data suggest that MAVENCLAD™ (Cladribine Tablets) selectively and discontinuously reduces B
and T lymphocytes, with lymphocyte counts return ing to normal range before the end of
Year 2
- The lymphocyte d ata presented at EAN Congress are consistent with
other clinical safety presentations of MAVENCLAD™ (Cladribine Tablets) at the
congress
Merck, a leading science and technology company, today announced the presentation of safety and efficacy data on MAVENCLAD™
(Cladribine Tablets) for the treatment of relapsing MS at the 3rd Congress of the European Association of Neurology
(EAN), in Amsterdam, the Netherlands. Data from the placebo-controlled CLARITY, CLARITY
Extension and ORACLE-MS clinical trials support the benefit: risk profile of Cladribine Tablets that have prompted an application
for marketing authorisation in the EU, and the recent positive opinion from the Committee for Medicinal Products for Human Use
(CHMP).
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In these studies, Cladribine Tablets was administered as two annual treatment courses in Years 1 and 2, with a total maximum
of 20 days of oral treatment equal to a dose of 3.5 mg/kg body weight, followed by no further active treatment in Years 3 and
4.
"These data presented at EAN Congress 2017 bring the MS treating community closer to understanding the mechanism of action of
Cladribine Tablets," said Professor Per Soelberg Sørensen, presenting author and Head of MS Research Unit, Danish Multiple
Sclerosis Centre. "These data support the emerging theories around the ability of some agents to selectively 'reset' the immune
system without the secondary autoimmunity that we sometimes see with treatments for relapsing MS. This would represent a
significant advance in the field."
Data from three key studies suggest that Cladribine Tablets selectively and discontinuously reduce both B and T lymphocytes in
patients with early and relapsing forms of MS. An early and discontinuous reduction of peripheral blood B cells was seen, with
cells numbers reaching a nadir at 13 weeks after treatment, followed by a rapid reconstitution toward baseline. A moderate
reduction in T cell counts was also shown, although to a lesser degree than B cells; this reduction was more pronounced in CD4+
than CD8+ lymphocytes.
An exploratory analysis of the CLARITY data suggests that if strict lymphocyte count rules are adhered to before each yearly
short course treatment, then the proportion of patients recovering at the end of Year 1 was 89.1% and at the end of Year 2 was
88.3%. Given the clinical effect observed during Years 1 and 2 of dosing in CLARITY, and beyond Years 1 and 2 with CT 3.5 mg/kg
in CLARITY EXT, these data demonstrate that the clinical effect observed is achieved without continuous immunosuppression and
through selective effects on B and T cell populations.
"Following last week's positive CHMP opinion, this integrated safety data, including 8 years of follow up in some patients,
further supports the use of Cladribine Tablets as a treatment option for patients with MS," said Luciano
Rossetti, Global Head of R&D for the biopharma business of Merck.
On 23 June, the Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion on the use of Cladribine
Tablets for relapsing MS, and this recommendation has been passed on to the European Commission (EC) to make the final decision
on the Marketing Authorization Application (MAA) later this year.
Lymphopenia was the most commonly reported adverse event (AE) in patients treated with Cladribine Tablets. The incidence of
infections was 48.3% with Cladribine Tablets and 42.5% with placebo, with 99.1% and 99.0% rated mild-to-moderate by
investigators.
MAVENCLAD™ is the proprietary name submitted to EMA for the investigational medicine Cladribine Tablets.
About MAVENCLAD™ (Cladribine Tablets)
Cladribine Tablets is a short-course oral therapy that is believed 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 June 2017, the
Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion on the use of Cladribine Tablets for highly
active relapsing MS, and this recommendation has been passed on to the EC to make the final decision on the Marketing
Authorization Application (MAA) later this year.
The clinical development program for Cladribine Tablets includes:
- The CLARITY (CLAdRIbine Tablets Treating MS OrallY) study: a two-year Phase III placebo-controlled study designed to
evaluate the efficacy and safety of MAVENCLAD as a monotherapy in patients with RRMS.
- The CLARITY extension study: a four-year Phase III placebo-controlled study following on from the CLARITY study, designed
to evaluate the safety and efficacy of MAVENCLAD over an extended administration for four years.
- 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.
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About Merck
Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000
employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer
or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD
televisions. In 2016, Merck generated sales of € 15.0 billion in 66 countries.
Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority
owner of the publicly listed corporate group. Merck holds the global rights to the Merck name and brand. The only exceptions are
the United States and Canada, where the company operates as EMD
Serono, MilliporeSigma and EMD Performance Materials.