Merck Begins Phase III Trial of Oral Cladribine for gMG

Merck, a prominent science and technology company, has announced the initiation of dosing for the first patient in the Phase III MyClad trial (NCT06463587). This study aims to evaluate the effectiveness and safety of oral cladribine for treating generalized Myasthenia Gravis (gMG). If successful, cladribine capsules could become the first oral treatment option for gMG, a rare neuromuscular disorder characterized by muscle weakness, which can significantly affect patients' daily lives.

Cladribine is designed to selectively target B and T lymphocytes, which are believed to be the primary contributors to gMG through the production of harmful autoantibodies. These autoantibodies cause inflammation at the neuromuscular junctions, disrupting communication between nerves and muscles. By focusing on this mechanism and offering short-course oral dosing that can be administered at home, cladribine aims to slow disease progression and reduce the overall treatment burden for patients.

Jan Klatt, Head of the Development Unit for Neurology & Immunology at Merck KGaA in Darmstadt, Germany, emphasized the potential of cladribine capsules as a unique therapeutic option for gMG. According to Klatt, this treatment approach could provide significant disease activity control, improve convenience for patients, and ultimately help them lead more normal lives.

The MyClad trial is a global Phase III study that is randomized, double-blind, and placebo-controlled. It will assess the efficacy and safety of cladribine capsules in 240 patients diagnosed with gMG.

Generalized Myasthenia Gravis (gMG) is a chronic autoimmune neuromuscular disorder that causes muscle weakness and fatigue, affecting approximately 700,000 people globally. The disease can impact individuals of any age but is more commonly diagnosed in young women between the ages of 20 to 30 and men aged 50 and older. gMG disrupts the communication between nerves and muscles, particularly at the neuromuscular junction, leading to a loss of muscle control. This can affect the eye muscles, as well as a variable combination of the arms, legs, and respiratory muscles. The severity and frequency of gMG symptoms are unpredictable, making the condition particularly debilitating and significantly impacting various aspects of daily life.

Merck has a strong history in neurology and immunology, with extensive research and development, as well as commercial experience in multiple sclerosis (MS). The company’s current MS portfolio includes two products: Rebif® (interferon beta-1a) and MAVENCLAD® (cladribine) tablets, both of which are used to treat relapsing forms of MS. Merck is committed to improving patient lives by addressing unmet medical needs. Beyond MS, Merck's pipeline includes potential therapies for various neuroinflammatory and immune-mediated diseases, such as systemic lupus erythematosus (SLE), cutaneous lupus erythematosus (CLE), and generalized myasthenia gravis (gMG).

Merck operates across the life science, healthcare, and electronics sectors, employing around 63,000 people who strive to make a positive impact on millions of lives every day. The company's efforts range from accelerating drug development and manufacturing to discovering new treatments for challenging diseases and enhancing the intelligence of devices. In 2023, Merck reported sales of €21 billion across 65 countries.

Founded in 1668, Merck has thrived through a combination of scientific exploration and responsible entrepreneurship. The founding family remains the majority owner of this publicly listed company. Globally, Merck holds the rights to its name and brand, except in the United States and Canada, where the company operates under the names MilliporeSigma in life science, EMD Serono in healthcare, and EMD Electronics in electronics.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!