Cladribine

In 2024, Multiple Sclerosis News Today highlighted key MS developments: updated McDonald criteria for diagnosis, limitations of anti-CD20 therapies in PPMS, high-dose vitamin D's potential to delay MS progression, FDA's breakthrough device designation for a myelin-repairing neurostimulator, promising experimental oral therapy PIPE-307, advancements in myelin-repairing treatments, ancient DNA's link to MS risk, long-term benefits of Mavenclad, obesity medications possibly lowering MS risk, and MS Awareness Month's focus on patient experiences.

Bionxt Solutions plans to launch a pilot clinical trial in H2 2025 comparing BNT23001, a sublingual cladribine formulation, to Mavenclad for MS treatment. The sublingual film aims to ease administration for patients with swallowing difficulties and is expected to act faster. Bionxt is working with a manufacturing partner and plans to file for clinical trial approval in Europe by mid-2025. Preclinical studies showed BNT23001 has comparable pharmacological properties to Mavenclad.

The CLARION study assesses long-term safety of cladribine tablets for MS using a common data model to harmonize data from multiple registries. It defines data quality indicators (DQIs) for representativeness, consistency, accuracy, and completeness to ensure data fitness for regulatory decisions. Results show high data consistency and accuracy, with improvements noted over time, supporting the study's ability to provide reliable safety evaluations.