Merck KGaA, Darmstadt, Germany, Begins Phase III Oral Cladribine Study in gMG

Merck KGaA, Darmstadt, Germany, a prominent science and technology company, has initiated the dosing of the first patient in its Phase III MyClad clinical trial (NCT06463587). This trial is being conducted to evaluate the efficacy and safety of oral cladribine for the treatment of generalized Myasthenia Gravis (gMG). If successful, cladribine capsules could become the first oral medication available for gMG patients. gMG is a rare neuromuscular disorder characterized by significant muscle weakness, which can considerably affect the quality of life for those afflicted.

Cladribine is believed to work by selectively targeting B and T lymphocytes. These cells are implicated in causing gMG by producing harmful autoantibodies that lead to inflammation at the neuromuscular junctions, where nerves and muscles connect. By focusing on this mechanism and allowing for a short course of oral dosing that can be administered at home, cladribine aims to slow disease progression while reducing the treatment burden on patients.

Jan Klatt, who heads the Development Unit Neurology & Immunology for Merck KGaA, Darmstadt, Germany, expressed optimism about the potential of cladribine. According to Klatt, the extensive experience Merck KGaA has in treating immune-driven neurological conditions positions cladribine capsules as a potentially significant therapeutic advancement for gMG. The treatment's goal is to offer substantial control over disease activity, improve patient convenience, and ultimately enable patients to maintain a more normal lifestyle.

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

Generalized Myasthenia Gravis is a chronic autoimmune neuromuscular disorder that leads to muscle weakness and fatigue. It affects approximately 700,000 people globally. The disorder can affect individuals of any age but is more commonly observed in young women aged 20 to 30 and men aged 50 and above. In gMG, the communication between nerves and muscles is disrupted at the neuromuscular junction, resulting in muscle weakness. This condition can lead to a loss of control over eye muscles and may involve a combination of limb and respiratory muscle weakness, making the disease's symptoms unpredictable and debilitating.

Merck KGaA, Darmstadt, Germany, has a well-established presence in neurology and immunology, boasting notable R&D and commercial experience in multiple sclerosis (MS). The company’s MS portfolio includes two treatments for relapsing MS: Rebif® (interferon beta-1a) and MAVENCLAD® (cladribine) tablets. The company's mission is to improve patients' lives by addressing unmet medical needs. Merck KGaA is also exploring new therapies for other neuroinflammatory and immune-mediated diseases, including systemic lupus erythematosus (SLE), cutaneous lupus erythematosus (CLE), and generalized myasthenia gravis (gMG).

Merck KGaA, Darmstadt, Germany, is a leading multinational science and technology company operating in life science, healthcare, and electronics sectors. With over 64,000 employees, the company aims to make a positive impact on millions of people worldwide by fostering joyful and sustainable living. In 2023, Merck KGaA, Darmstadt, Germany, reported sales of €21 billion across 65 countries.

The company holds the global rights to the name and trademark “Merck” except in the United States and Canada, where it operates as MilliporeSigma in life science, EMD Serono in healthcare, and EMD Electronics in electronics. Since its founding in 1668, the company has achieved numerous scientific and technological advancements, driven by a commitment to scientific exploration and responsible entrepreneurship. The founding family remains the majority owner of this publicly listed company.

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