Merck KGaA (Merck) has dosed the first subject in a Phase III trial of oral Cladribine to treat generalised myasthenia gravis (gMG), a rare neuromuscular disorder.
Called MyClad, the international, randomised, double-blind, and placebo-controlled study aims to assess the efficacy and safety of Cladribine capsules compared to a placebo.
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Enrolling 240 patients diagnosed with gMG, the trial is set to explore not only the immediate efficacy but also the long-term impacts of the therapy, including the necessity for retreatment.
It will also characterise the pharmacokinetics (PK) of the new Cladribine formulation within this patient group.
The study is structured into three distinct periods: the double-blind placebo control (DBPC) pivotal period, followed by two extensions, the blinded extension (BE) and the retreatment (RT) period.
This design is intended to provide a comprehensive understanding of Cladribine’s performance over an extended timeframe.
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By GlobalDatagMG is characterised by muscle weakness, which can be debilitating and significantly affect the quality of life for those affected.
Cladribine works by targeting B and T lymphocytes, which are believed to be at the core of gMG pathogenesis through the production of autoantibodies that lead to inflammation at the neuromuscular junction.
The oral dosing regimen of Cladribine, which can be taken at home, could offer a convenient and effective way to slow disease progression by addressing its underlying cause while reducing the treatment burden for patients, the company noted.
Merck neurology and immunology business development head Jan Klatt said: “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.
“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.”
In June this year, the company discontinued the Phase III TrilynX trial of xevinapant to treat unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN).
