Merck administers dose to first patient in Phase III study of Oral Cladribine in Generalised Myasthenia Gravis (gMG)

Merck announced that the first patient has been dosed in the Phase III MyClad trial evaluating the efficacy and safety of oral cladribine for the treatment of generalised Myasthenia Gravis (gMG). Cladribine capsules have the potential to be the first oral treatment for gMG patients. gMG is a rare, neuromuscular disorder causing muscle weakness that can be severe and have a significant impact on patients’ lives.

Cladribine is expected to selectively target B and T lymphocytes. These cells are thought to be the root cause of gMG through the production of the harmful autoantibodies that drive inflammation at the connection points between nerves and muscles. This mechanism of action coupled with a short course of oral dosing taken at home may ultimately slow the progression of the disease by targeting its underlying cause while diminishing the treatment burden.

MyClad is a global Phase III, randomised, double-blind and placebo-controlled study designed to assess the efficacy and safety of cladribine capsules in 240 patients with gMG.

 About Generalised Myasthenia Gravis

Generalised Myasthenia Gravis (gMG) can strike anyone at any age but is more frequently seen in young women (aged 20 to 30) and men aged 50 and older. In gMG, the communication between the nerves and the muscles, particularly at the neuromuscular junction (NMJ), is disrupted causing muscle weakness. This can result in the loss of control of the eye muscles and a variable combination of the arms, legs, and respiratory muscles. The unpredictable severity and frequency of symptoms in gMG patients can be debilitating, significantly impacting various aspects of day-to-day life.