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Merck Serono Completes Patient Enrollment in CLARITY Phase III Pivotal Clinical Trial of Oral Cladribine

Oral Cladribine on Track to Become First Oral Disease Modifying Treatment for Multiple Sclerosis.

Merck Serono announced today that patient enrollment has been completed in the CLARITY (CLAdRIbine Tablets Treating MS OrallY) study, a Phase III pivotal clinical trial evaluating the efficacy and safety of Merck Serono's proprietary oral formulation of cladribine for the treatment of relapsing forms of multiple sclerosis (MS).

"The completion of patient enrollment into the CLARITY pivotal trial is a major milestone in the development program of oral cladribine," said Franck Latrille, Merck Serono's Head of Product Development. "It brings us one step closer to our objective of offering patients the first oral therapy for first line treatment of multiple sclerosis, with the convenience of short courses of therapy given intermittently."

The CLARITY study is a two-year (96 weeks), randomised, double-blind, placebo-controlled, international trial. It enrolled more than 1,300 patients and will provide data on key endpoints including clinical relapses, disability progression and magnetic resonance imaging (MRI). Study participants have been enrolled in one of the three arms of the study to receive one of two different dose regimens of oral cladribine or matching placebo tablets. In the study, oral cladribine is given in two or four treatment cycles in the first year, with each cycle consisting of daily administration for five consecutive days, which means study patients take oral cladribine therapy for only 10 or 20 days during the year. In the second year, two treatment cycles are administered.

The increased convenience resulting from the oral intermittent administration of oral cladribine has the potential to address an important unmet medical need in patients with MS.

Oral cladribine was designated a Fast Track product by the US Food and Drug Administration (FDA) in September 2006. Under Fast Track designation, oral cladribine is eligible for Priority Review and the FDA may consider portions of the marketing application for review before the New Drug Application (NDA) is completed.

About oral cladribine

Merck Serono's proprietary oral formulation of cladribine is currently being evaluated in Phase III as a treatment for patients with relapsing forms of multiple sclerosis (MS). Cladribine is a small molecule that interferes with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are involved in the pathological process of MS. Through its differentiated mechanism of action, oral cladribine may offer a safe and effective new option to patients with MS.

Source: Serono International S A

As far as I know, this really does put mylinax in the lead for the phase III drugs in the pipeline. I don't think any of the other trials have completed enrollment yet. This means the trial will end at the end of 2008, so they will be filing sometime in 2009, hopefully, and hopefully getting approval in 2009 too.

Is this the drug that had an effect on lesions but didn't do much for either disability progression or relapses? Or am I confusing it with something else? Does anyone have any good links to Phase II results?