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The global biopharmaceutical company released research data on rozanolixizumab and zilucoplan at the 2021 ASH annual meeting and exposition.
Positive topline results were announced at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition by Union Chimique Belge (UCB) from a phase 3 MycarinG (MG0003) trial study that investigated the efficacy and safety of rozanolixizumab. Rozanolixizumab is a subcutaneously infused monoclonal antibody targeting the neonatal Fc receptor (FcRn).
Investigators compared the effect of rozanolixizumab in patients with generalized myasthenia gravis (gMG) with that of a placebo and found that it was well tolerated and no new safety signals were identified.
The primary endpoint of the trial was met. Results showed a statistically significant and clinically meaningful change from baseline in the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL), total score at day 43.
The secondary endpoints included response rates, changes in the Myasthenia Gravis composite (MGC) score, the Quantitative MG (QMG) score, patient-reported outcomes and adverse events (AEs) and were all met with statistical significance.
Rozanolixizumab has not been approved for use in any indication by any regulatory authority worldwide and the US Food and Drug Administration (FDA) has not yet established the efficacy and safety profile.
Final Phase 3 data will be presented at a medical meeting in 2022. UCB expects regulatory filings in the US, European Union and Japan from Q3 2022.
“Today’s encouraging findings from the MycarinG study show the potential of rozanolixizumab in the treatment of myasthenia gravis, and further reinforce the suggestion that FcRn inhibition may be a promising approach for this disease,” Vera Bril, MycarinG study Lead Investigator, Professor of Medicine (Neurology), University of Toronto, and Director of the Neuromuscular Section, Division of Neurology, University of Toronto and University Health Network, Toronto, Canada said in a statement.
Zilucoplan is another medicine that UCB is investigating. The developmental peptide inhibitor of complement component 5 (C5 inhibitor) could be promising for patients living with generalized myasthenia gravis (gMG).
The safety and efficacy of zilucoplan have not been established or approved for use in any indication by any regulatory authority worldwide, however, preliminary data from the company’s RAISE study are predicted to be ready shortly.
“We are enthusiastic about these positive and clinically meaningful results, which mark a critical step forward for rozanolixizumab and UCB’s commitment to delivering differentiated solutions for people living with rare diseases, such as myasthenia gravis,” Iris Loew-Friedrich, Executive Vice-President and Chief Medical Officer at UCB said in a statement. “In line with our ambition to deliver a portfolio of treatment options which could improve and simplify the treatment experience for patients and physicians, we are committed to bringing transformational outcomes and experiences to those in need. We wholeheartedly thank the MG community for their ongoing partnership and participation in this study.”