Phase 3 clinical trial commences for oral myasthenia gravis treatment
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The first patient has been dosed in a phase 3 clinical trial of oral cladribine for the treatment of generalized myasthenia gravis, according to the manufacturer.
In a press release, Merck KGaA said that the MyClad study will be a global, randomized, double-blind, placebo-controlled study to investigate safety of cladribine capsules in 240 individuals with the neurodegenerative condition.
Cladribine’s mechanism of action selectively targets B and T lymphocytes, thought to be the root cause of generalized myasthenia gravis, which causes significant difficulty in moving the eyes, throat and limbs due to loss of communication between nerves and muscles. In assessing oral cladribine, Merck said it may offer administration in patients’ homes, lessening patient treatment burden while slowing disease progression.
“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,” Jan Klatt, head of development unit Neurology & Immunology for the Healthcare business of Merck KGaA, stated in the release.