UCB has announced positive results from the phase 3 RAISE trial and the ongoing phase 3 RAISE-XT open-label extension study evaluating the long-term effect of Zilbrysq (zilucoplan) on fatigue in adults living with mild-to-severe anti-acetylcholine receptor (AChR) antibody-positive generalised myasthenia gravis (gMG).
Published in the Journal of Neurology, the results mark Zilbrysq as the first C5 inhibitor to show a clinically meaningful reduction in fatigue in this patient population.
gMG is a rare and chronic autoimmune disease that is characterised by dysfunction and damage at the neuromuscular junction and is usually driven by the complement cascade, immune cells and pathogenic immunoglobulin G autoantibodies.
The once-daily subcutaneous Zilbrysq works to inhibit complement-mediated damage to the neuromuscular junction through its targeted dual mechanism of action.
By week 12 of the RAISE study, results showed that gMG patients treated with Zilbrysq demonstrated clinically meaningful improvements in fatigue scores and severity versus placebo, which were sustained to week 60 in RAISE-XT.
In addition, the majority of patients who had severe or moderate fatigue saw an improvement to mild or no fatigue by week 60 after receiving Zilbrysq, which was well tolerated and had a favourable long-term safety profile.
Donatello Crocetta, head of global rare disease and rare medical, UCB, commented: “This post hoc analysis reveals Zilbrysq’s role in helping manage an important yet understudied symptom of gMG… that can help reduce the ongoing burden of gMG, giving patients flexible treatment options that work alongside their daily life.”
Zilbrysq has already received approvals from the European Commission (EC), the US Food and Drug Administration and the Japanese Ministry of Health, Labour and Welfare for the treatment of gMG.
Most recently, in January, the Medicines and Healthcare products Regulatory Agency approved the C5 inhibitor, based on positive results from the RAISE study, as an add-on therapy for a subset of patients with gMG who are AChR antibody-positive.
The results follow the EC’s approval of UCB’s Bimzelx (bimekizumab) in April, to treat active moderate-to-severe hidradenitis suppurativa, an inflammatory skin disease, in adults who have had an inadequate response to conventional systemic therapy.