Merck, a prominent science and technology company, has announced that the first patient has been dosed in the Phase III MyClad trial (NCT06463587), which is investigating the efficacy and safety of oral cladribine for the treatment of generalized Myasthenia Gravis (gMG). If successful, cladribine capsules could become the first oral treatment option for gMG patients. gMG is a rare neuromuscular disorder characterized by muscle weakness that can significantly impact patients’ quality of life.
Cladribine is expected to selectively target B and T lymphocytes, which are believed to be the primary drivers of gMG by producing harmful autoantibodies that cause inflammation at the neuromuscular junction. This mechanism, combined with a short course of oral dosing that can be administered at home, may slow disease progression by addressing its underlying cause while reducing the treatment burden.
“Given our extensive experience in addressing patients’ needs in immune-driven neurological conditions, we believe that cladribine capsules represent a highly differentiated potential therapeutic option for gMG,” said Jan Klatt, Head of Development Unit Neurology & Immunology for Merck KGaA, Darmstadt, Germany. “This treatment approach holds the promise of achieving a high degree of disease activity control, offering greatly improved convenience, and ultimately enabling patients to live their lives as normally as possible.”
The MyClad trial is a global Phase III, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of cladribine capsules in 240 patients with gMG.
