Merck Doses First Patient in Phase III Study of Oral Cladribine for gMG

Merck, a prominent science and technology corporation, recently announced the commencement of the global Phase III MyClad trial (NCT06463587), with the first patient receiving a dose. This trial aims to evaluate the efficacy and safety of cladribine capsules as a potential oral treatment for generalized Myasthenia Gravis (gMG). gMG is a rare, chronic autoimmune disorder that leads to muscle weakness, particularly affecting the eyes, mouth, throat, and limbs. If successful, cladribine capsules could become the first oral therapeutic option for gMG patients.

Cladribine’s mode of action involves selectively targeting B and T lymphocytes, which are believed to be responsible for producing harmful autoantibodies that cause inflammation at neuromuscular junctions. By addressing these underlying causes, cladribine may slow the disease's progression and reduce the treatment burden, given its short course oral dosing that can be managed at home.

Jan Klatt, Head of Development Unit Neurology & Immunology for Merck KGaA, Darmstadt, Germany, expressed optimism about the potential of cladribine capsules. He highlighted the company's extensive experience in addressing immune-driven neurological conditions and noted that this approach could offer significant improvements in disease control and patient convenience, enabling a more normal life for those affected by gMG.

The MyClad study is a large-scale, randomized, double-blind, and placebo-controlled trial involving 240 patients worldwide. The primary objective is to assess both the efficacy and safety of cladribine capsules in treating gMG.

gMG impacts approximately 700,000 people globally and can affect individuals of any age, though it is more prevalent among young women (ages 20-30) and older men (ages 50 and above). The disorder disrupts communication between nerves and muscles at the neuromuscular junction, leading to muscle weakness and fatigue. This can result in a loss of muscle control in the eyes, arms, legs, and respiratory system, severely affecting daily life due to the unpredictability and severity of symptoms.

Merck has a notable history in the fields of neurology and immunology, particularly in the area of multiple sclerosis (MS). The company's current MS portfolio includes Rebif® (interferon beta-1a) and MAVENCLAD® (cladribine) tablets for the treatment of relapsing MS. Merck is committed to addressing unmet medical needs and improving patient lives. Beyond MS, Merck's research pipeline explores therapies for other neuroinflammatory and immune-mediated diseases, such as systemic lupus erythematosus (SLE), cutaneous lupus erythematosus (CLE), and generalized myasthenia gravis (gMG).

As a leading science and technology company, Merck operates across life sciences, healthcare, and electronics, with around 63,000 employees worldwide. In 2023, the company generated sales of €21 billion across 65 countries. Merck's focus on scientific exploration and responsible entrepreneurship has driven its success since its establishment in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds global rights to its name and brand, operating under different names in the United States and Canada: EMD Serono in healthcare, MilliporeSigma in life sciences, and EMD Electronics.

Merck continues to innovate and make impactful advancements in various fields, aiming to improve the quality of life and address some of the most pressing medical challenges.

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