September 17, 2008

Merck Completes Enrollment in Phase III Multiple Sclerosis Trial

Merck KGaA has announced that its Merck Serono division has completed patient enrollment in the Reflex trial of Rebif in patients at risk of developing multiple sclerosis.

The randomized, double-blind, placebo-controlled, international Phase III trial is designed to evaluate the therapeutic benefit of Rebif (interferon beta-1a) on the time to conversion to multiple sclerosis (MS) in people with a first clinical event suggestive of the disease.

A total of 517 patients considered at risk of developing MS due to a recently experienced isolated demyelinating event and having magnetic resonance imaging (MRI) brain scans consistent with early signs of MS have been enrolled in the Reflex trial.

Study participants were randomized in a 1:1:1 ratio to receive either Rebif 44 micrograms three times a week, Rebif 44 micrograms once a week, or placebo as a subcutaneous injection. Patients will be treated for a period of 24 months, or up to the time when they experience a second attack leading to a diagnosis of clinically definite MS. At this point, patients are offered open-label treatment with Rebif 44 micrograms three times a week.

The primary endpoint of the Reflex trial is time to conversion to MS, according to the McDonald criteria. Further endpoints include time to conversion to clinically definite MS, assessments of MRI brain scans, clinical relapses and disability progression. The Reflex trial is being conducted with the new formulation of Rebif.

Anton Hoos, executive vice president of global development at Merck Serono, said: "It has been demonstrated that treatment with interferon beta can reduce the risk of developing multiple sclerosis. However, additional research still needs to be conducted in this area and we believe the Reflex study will provide valuable insights."