UCB, a global biopharmaceutical company, has announced data from two clinical studies assessing ZLP-AI in adult patients who are anti-AChR antibody positivegMG as well as in healthy volunteers.
The studies evaluated the effectiveness of a ZLP-AI as a potential new alternative administration option, and the bioequivalence of ZLP-AI relative to ZLP-PFS. ZLP-AI is an investigational administration option for the treatment of gMG in adult patients who are anti-AChR antibody positive and the presentation is currently not approved in the US.
DV0013 was a phase 3b open-label, multi-centre study in adult patients with gMG self-administering zilucoplan via auto-injector once daily. DV0012 was a phase 1, open-label, single-centre, two-period crossover study in healthy adult volunteers to establish bioequivalence of zilucoplan delivered via an auto-injector pen compared with a pre-filled syringe.
UCB will also present five additional studies and data analyses, further highlighting UCB’s ongoing commitment to improving outcomes for people living with gMG including:
- Response to rozanolixizumab across treatment cycles in patients with generalised myasthenia gravis: a post hoc analysis of final pooled phase 3 data: an analysis evaluated the response to rozanolixizumab over multiple treatment cycles in adult patients with gMG, based on their cycle 1 response.
- Sustained minimal symptom expression in generalised myasthenia gravis: a 120-week post hoc analysis of RAISE-XT: A post hoc analysis assessed the durability of minimal symptom expression (MSE) response during treatment with zilucoplan in patients with gMG.
- Treatment goals in myasthenia gravis: expert consensus recommendations. Using the RAND/UCLA appropriateness method: 17 myasthenia gravis experts from North America, Europe and Asia reached consensus on 21 recommendations to define and operationalise treatment goals for patients with MG. Recommendations emphasize the importance of patient engagement and education, reassessing and changing treatment to achieve goals and care coordination with other specialists.
- Treatment characteristics and healthcare resource utilisation among adult patients with generalised myasthenia gravis initiating rozanolixizumab in the United States: This real-world, retrospective, non-interventional cohort study of adult patients (N=719) receiving rozanolixizumab in the US evaluated treatment patterns and healthcare resource utilisation (HCRU).
- Missed opportunities for pharmacist intervention among Medicare fee-for-service beneficiaries with myasthenia gravis: a real-world claims analysis.
About generalized myasthenia gravis (gMG)
gMG is a rare neuromuscular autoimmune disease that has a global prevalence of 150–350 cases per 1 million people. People living with gMG can experience a variety of symptoms, including severe muscle weakness that can result in double vision, drooping eyelids, difficulty with swallowing, chewing and talking, as well as life-threatening weakness of the muscles of respiration.
In gMG, pathogenic autoantibodies can impair synaptic transmission at the neuromuscular junction (NMJ) by targeting specific proteins on the post-synaptic membrane. This disrupts the ability of the nerves to stimulate the skeletal muscle and results in a weaker contraction. gMG can occur in any race, gender or age.
