Myasthenia gravis (MG) is a debilitating, chronic autoimmune neuromuscular disease in which the body produces auto-antibodies that prevent the nerves from sending messages to the muscles.
The randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the efficacy and safety of MMF to maintain or improve symptom control with reduced corticosteroids in patients with myasthenia gravis over a treatment period of 36 weeks.
The primary endpoint of responder status in the trial encompasses both minimal disease activity and low steroid dose. The company expects to complete the trial in late 2006.
“The completion of enrolment for our global phase III study of MMF in MG has been achieved on schedule. This success reflects the strong interest from both patients and clinical investigators in the potential of MMF in treating this debilitating and life-threatening condition,” said Dr Reinhard Baildon, executive vice president of clinical & regulatory affairs at Aspreva.