Merck, a leading science and technology company, has announced that the first patient has been dosed in the Phase III MyClad trial (NCT06463587). This trial aims to evaluate the efficacy and safety of oral cladribine for treating generalized Myasthenia Gravis (gMG). If successful, cladribine capsules could become the first oral treatment available for gMG patients, a rare neuromuscular disorder that causes severe muscle weakness and significantly impacts patients’ lives.
Cladribine is designed to selectively target B and T lymphocytes, which are believed to be responsible for gMG by producing harmful autoantibodies that cause inflammation at the neuromuscular junctions. By addressing this underlying mechanism and offering a short course of oral treatment that can be administered at home, cladribine may slow disease progression and reduce the overall treatment burden for patients.
Jan Klatt, Head of Development Unit Neurology & Immunology at Merck KGaA, Darmstadt, Germany, commented, “With our extensive experience in treating immune-driven neurological conditions, we believe that cladribine capsules represent a highly promising therapeutic option for gMG. This approach aims to achieve significant disease control, enhance patient convenience, and allow individuals to lead as normal a life as possible.”
The MyClad trial is a global Phase III, randomized, double-blind, placebo-controlled study designed to evaluate cladribine capsules in 240 patients with gMG.
Generalized Myasthenia Gravis (gMG) is a rare, chronic autoimmune neuromuscular disorder characterized by muscle weakness and fatigue, impacting an estimated 700,000 people worldwide. The disease can strike anyone at any age but is more frequently seen in young women (age 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 in 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.
