UCB S.A. (OTC:UCBJY) (OTC:UCBJF) on Wednesday presented new data at the International Congress on Neuromuscular Diseases 2026 showing that long-term treatment with rozanolixizumab and zilucoplan delivered sustained improvements across a broad range of symptoms in adults with generalized myasthenia gravis (gMG).
gMG is a chronic autoimmune disorder where immune proteins attack the communication between nerves and muscles. The company also shared findings supporting the usability of its newly approved zilucoplan pre-filled pen.
Rozanolixizumab Demonstrates Durable Symptom Improvements
A pooled post hoc analysis of the Phase 3 MycarinG study and its open-label extensions evaluated repeated symptom-driven rozanolixizumab treatment cycles in 129 adults with gMG who received at least two treatment cycles.
The analysis found consistent improvements in both clinician- and patient-reported measures of double vision and eyelid drooping across up to 13 treatment cycles.
Patients also reported better eye-related quality of life, including fewer problems using their eyes.
Another pooled analysis of the same studies showed sustained improvements across Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) measures.
Benefits were observed in symptoms including double vision, eyelid droop, speech, chewing, swallowing, facial muscle function, respiratory symptoms, and limb strength.
Among patients receiving at least one treatment cycle, 93.1% experienced treatment-emergent adverse events (TEAEs), with most classified as mild or moderate.
Headache, diarrhea, and COVID-19 were the most frequently reported events, while investigators reported no increase in TEAE incidence with repeated treatment cycles.
MuSK-Positive Patients Also Showed Consistent Benefit
UCB also reported pooled results from 12 adults with MuSK antibody-positive gMG who received repeated symptom-driven rozanolixizumab treatment.
Patient-reported MG-ADL scores improved from a weighted mean of 10.4 at baseline to 5.2 by Day 43 across up to 13 cycles, while weighted mean QMG scores declined from 16.8 to 9.4.
The findings suggested consistent clinical benefit alongside an acceptable safety profile. Among 18 MuSK-positive patients who received at least one treatment cycle, 77.8% reported TEAEs, most of which were mild or moderate.
Zilucoplan Data Show Sustained Benefit And Support Self-Administration
A separate post hoc analysis of the Phase 3 RAISE study and its ongoing RAISE-XT extension found that adults with anti-acetylcholine receptor antibody-positive gMG receiving zilucoplan experienced greater improvements than placebo across multiple MG-ADL measures by Week 12, including chewing, talking, eyelid droop, and rising from chairs.
The improvements increased further and remained durable through Week 120 in the extension study, with similarly positive findings across QMG and MG Quality of Life assessments.
UCB also presented results from a human factors validation study involving 100 participants evaluating the newly approved zilucoplan pre-filled pen. Without prior training, 90% of participants completed an injection on their first attempt.
The study found no new use-related safety risks, supporting the device as an additional self-administration option.
Photo via Shutterstock
Login to comment