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MyClad is a global Phase III study to evaluate the efficacy and safety of cladribine capsules for the treatment of generalized myasthenia gravis (gMG).
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Cladribine capsules could be the first oral treatment for gMG patients
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gMG is a rare, chronic neuromuscular autoimmune disease that causes muscle weakness in the eyes, mouth, throat and limbs
DARMSTADT, 29 August 2024–(BUSINESS WIRE)–Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced that the first patient has been treated in the Phase III MyClad study (NCT06463587) evaluating the efficacy and safety of oral cladribine for the treatment of generalized myasthenia gravis (gMG). Cladribine capsules may be the first oral treatment for gMG patients. gMG is a rare neuromuscular disease that causes muscle weakness that can be severe and significantly impact patients’ lives.
Cladribine is designed to specifically target B and T lymphocytes. These cells are thought to be the root cause of gMG because they produce harmful autoantibodies that trigger inflammation at the junctions between nerves and muscles. This mechanism of action, combined with short-term oral administration at home, may ultimately slow disease progression by targeting the underlying cause while reducing the burden of treatment.
“Based on our extensive experience in treating patients with immune-related neurological diseases, we are convinced that cladribine capsules represent a highly differentiated potential therapeutic option for gMG,” said Jan Klatt, Head of the Neurology & Immunology Development Unit in the Healthcare business of Merck KGaA, Darmstadt, Germany. “This treatment approach promises a high level of disease activity control, offers significantly more comfort and ultimately enables patients to live their lives as normally as possible.”
MyClad is a global, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of cladribine capsules in 240 patients with gMG.
About generalized myasthenia gravis
Generalized myasthenia gravis (gMG) is a rare, chronic neuromuscular autoimmune disease characterized by muscle weakness and fatigue that affects an estimated 700,000 people worldwide. The disease can affect anyone at any age, but is more common in young women (20 to 30 years old) and men over 50 years of age. In gMG, communication between the nerves and muscles, particularly at the neuromuscular junction (NMJ), is disrupted, resulting in muscle weakness. This can lead to loss of control of the eye muscles and a variable combination of the arm, leg, and respiratory muscles. The unpredictable severity and frequency of symptoms in gMG patients can be debilitating and significantly affect various aspects of daily life.
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Merck KGaA, Darmstadt, Germany in Neurology and Immunology
Merck KGaA, Darmstadt, Germany, has a long tradition in the fields of neurology and immunology as well as extensive research and development experience and commercial experience in the field of multiple sclerosis (MS). The company’s current MS portfolio includes two products for the treatment of relapsing-remitting MS – Rebif® (Interferon Beta-1a) and MAVENCLAD® (Cladribine) tablets. Merck KGaA, Darmstadt, Germany, is committed to improving patients’ lives by addressing areas of unmet medical need. In addition to Merck KGaA, Darmstadt, Germany’s commitment to MS, the company also has a pipeline focused on discovering new therapies that have potential for other neuroinflammatory and immune-mediated diseases, including systemic lupus erythematosus (SLE), cutaneous lupus erythematosus (CLE), and generalized myasthenia gravis (gMG).
About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates in life sciences, healthcare and electronics. More than 64,000 employees work every day to positively improve the lives of millions of people by creating more joyful and sustainable ways of living. From providing products and services that accelerate the development and manufacture of medicines, to discovering unique ways to treat the most difficult diseases, to enabling smart devices – the company is everywhere. In 2023, Merck KGaA, Darmstadt, Germany, generated sales of EUR 21 billion in 65 countries.
The company owns the rights to the name and brand “Merck” worldwide. The only exceptions are the USA and Canada, where the business areas of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in the field of life sciences, EMD Serono in the field of healthcare and EMD Electronics in the field of electronics. Since its founding in 1668, scientific research and responsible entrepreneurship have been the key to the company’s technological and scientific progress. To this day, the founding family is the majority owner of the listed company.
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