Innovative MyClad Study Testing Cladribine Capsules in Generalized Myasthenia Gravis: Henry Kaminski, MD

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The Meta A. Neumann Professor of Neurology at George Washington University provided an overview of a new phase 3 study testing the efficacy and safety of cladribine versus placebo in generalized myasthenia gravis. [WATCH TIME: 3 minutes]

WATCH TIME: 3 minutes

"It’s good for our patient population to know that we care about seronegative patients...we have a rigorous trial that can evaluate a medication in that group."

Cladribine (Mavenclad; EMD Serono) is a synthetic deoxyadenosine analog classified as an anti-metabolite and anti-pyrimidine agent. Approved in 2008 as a treatment for relapsing forms of multiple sclerosis (MS), this agent mimics severe immunodeficiency disorder by selectively disrupting T-cell and B-cell immunity. Within cells, high cladribine concentrations increase the expression of deoxycytidine kinase, leading to lymphocyte apoptosis.

At the 2024 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) meeting, held October 15-18, in Savannah, Georgia, investigators presented the clinical design of MyClad, a phase 3 trial evaluating the efficacy and safety of cladribine in myasthenia gravis (MG). The study, which is actively recruiting, is a 3-year trial comprised of a 24-week double-blind, placebo-controlled period, followed by a blinded 24-week extension where patients will be re-randomized to the opposing treatment. Led by Henry Kaminski, MD, the study looks to recruit 240 participants, including those who are seropositive and seronegative for acetylcholine receptor (AChR) and muscle-specific kinase (MuSK) MG.

Kaminski, who serves as the Meta A. Neumann Professor of Neurology at George Washington University, sat down with NeurologyLive® at the meeting to discuss the ins and outs of the study, including patient demographics and end points. In addition, he spoke on the uniqueness of the trial in including seronegative patients, as this group is often excluded from clinical trials, despite having confirmed gMG through other diagnostic medicines. On a more broad level, he spoke on how the trial aims to assess cladribines applicability in real-world practice.

Click here for more AANEM 2024 coverage.