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Monday, July 3, 2017

Mavenclad Reduces MS Relapses by Reseting the Immune System

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Data Provide Additional Insight Into the Mode of Action of MAVENCLAD(TM) (Cladribine Tablets) in Patients With Relapsing MS

DARMSTADT, Germany, Jun 26, 2017 (PR Newswire Europe via COMTEX) -- DARMSTADT, Germany, June 26, 2017 /PRNewswire/ --

- Data suggest that MAVENCLAD(TM) (Cladribine Tablets) selectively and discontinuously reduces B and T lymphocytes, with lymphocyte counts returning to normal range before the end of Year 2 - The lymphocyte data presented at EAN Congress are consistent with other clinical safety presentations of MAVENCLAD(TM) (Cladribine Tablets) at the congress.
Merck, a leading science and technology company, today announced the presentation of safety and efficacy data on MAVENCLAD(TM) (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).

About MAVENCLAD(TM) (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.

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 SArensen, 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(TM) is the proprietary name submitted to EMA for the investigational medicine Cladribine Tablets.

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