Trial boost for Merck KGaA’s cladribine
pharmafile | April 19, 2010 | News story | Research and Development | Cladribine, MS, Merck KGaA, Merck Serono
New data from German pharma company Merck suggests its oral multiple sclerosis treatment cladribine has been successful in treating relapsing forms of the disease.
Analyses of the phase III CLARITY clinical trial, presented at the annual meeting of the American Academy of Neurology (AAN), show patients taking the tablets experienced less relapse and disability progression.
Over the 96-week trial, 43% and 44% of patients on cladribine 3.5 mg/kg and 5.25 mg/kg respectively saw disease activity-free status compared with 16% of patients who received placebo.
There were also reductions in the annualised relapse rate over the placebo group across factors such as gender, age, treatment history, number of relapses in the previous 12 months and baseline disease disability.
Merck says there is also a financial benefit, with patients needing to consume fewer healthcare resources and improving their productivity, relative to placebo.
There were also reduced proportions of circulating CD4+ T cells relative to the total number of lymphocytes at the end of treatment periods compared to baseline.
Cladribine is believed to interfere with white blood cells, particularly lymphocytes, which are thought to be involved in the development of MS.
“The relevance of the CLARITY study is further substantiated by the series of additional analyses presented at AAN,” said Bernhard Kirschbaum, head of global R&D at Merck Serono.
“We are committed to continuing to work with regulatory authorities to bring cladribine tablets to patients at the earliest point in time,” he added.
The primary endpoint of the CLARITY study was the relapse rate over 96 weeks.
Merck already has big-selling MS treatment Rebif (interferon beta 1a), whose revenues were up 15% last year to 1.5 billion euros.
Despite cladribine receiving a ‘refuse to file’ letter from the FDA in November, Merck remains optimistic the drug will be approved this year.
The new treatment is still tipped to reach the market ahead of its rival, Novartis/Mitsubishi Tanabe’s FTY-720.
If approved, the drug would allow patients to stop taking betainterfon injections, while offering similar protection against relapses.
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