Positive Phase III top-line results for rozanolixizumab in gMG
Belgium’s largest drugmaker UCB (Euronext Brussels: UCB) has announced positive top-line results from the Phase III MycarinG (MG0003) trial study investigating the efficacy and safety of rozanolixizumab, a subcutaneously infused monoclonal antibody targeting the neonatal Fc receptor (FcRn), versus placebo in patients with generalized myasthenia gravis (gMG).
- The trial met its primary endpoint, demonstrating a statistically-significant and clinically-meaningful change from baseline in the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL), an eight-item patient-reported scale developed to assess MG symptoms and their effects on daily activities, total score at Day 43.
- All secondary endpoints were also met with statistical significance. Secondary endpoints include response rates, changes in the Myasthenia Gravis composite (MGC) score, the Quantitative MG (QMG) score, patient-reported outcomes and adverse events (AEs).
Overall rozanolixizumab was well tolerated, and no new safety signals were identified. The final Phase III data and additional details will be presented at a forthcoming medical meeting in 2022.
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