Merck Announces First Patient Dosed in Phase III Study of Oral Cladribine in Generalized Myasthenia Gravis (gMG)

August 30, 2024,Darmstadt, Germany : Not intended for UK-, US- or Canada-based media

Merck, a leading science and technology company, today announced the first patient has been dosed in the Phase III MyClad trial (NCT06463587) evaluating the efficacy and safety of oral cladribine for the treatment of generalized 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 oral dosing taken at home may ultimately slow the progression of the disease by targeting its underlying cause while diminishing 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 the Healthcare business of 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.”

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