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The first positive results were announced at the 2021 annual meeting and exhibition of the American Society of Hematology (ASH) by the Belgian Chemical Union (UCB) from a phase 3 study MycarinG (MG0003 ) who reviewed the efficacy and safety of rozanolixizumab. Rozanolixizumab is a subcutaneously infused monoclonal antibody targeting the neonatal Fc receptor (FcRn).
The researchers compared the effect of rozanolixizumab in patients with generalized myasthenia gravis (gMG) with that of placebo and found that it was well tolerated and that no new safety signals were identified.
Research on rozanolixizumab
The primary endpoint of the trial was met. The results showed a statistically significant and clinically significant change from baseline in the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL), total score on day 43.
Secondary endpoints included response rates, changes in Composite Myasthenia Gravis (MGC) score, Quantitative MG score (QMG), patient-reported outcomes and adverse events (AEs) and were all achieved with statistical significance.
Rozanolixizumab has not been approved for use in any indication by any regulatory authority worldwide, and the United States Food and Drug Administration (FDA) has not yet established the efficacy and safety profile.
The final phase 3 data will be presented at a medical meeting in 2022. UCB expects regulatory filings in the United States, the European Union and Japan from the third quarter of 2022.
“The encouraging results of today’s MycarinG study show the potential of rozanolixizumab in the treatment of myasthenia gravis and further support the suggestion that inhibition of FcRn may be a promising approach for this disease”, Vera Bril, Principal Investigator of the MycarinG Study, Professor of Medicine (Neurology), University of Toronto, and Head of Neuromuscular Section, Division of Neurology, University of Toronto and University Health Network, Toronto, Canada said in a statement.
Zilucoplan research
Another drug UCB is studying is Zilucoplan. The peptide inhibitor of complement component 5 development (inhibitor C5) may show promise 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 should be available shortly.
“We are excited about these positive and clinically meaningful results, which mark a critical milestone for rozanolixizumab and UCB’s commitment to provide differentiated solutions to 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 that could enhance and simplify the treatment experience for patients and physicians, we are committed to bringing transformational results and experiences to those who need them. We sincerely thank the MG community for their continued partnership and participation in this study. “
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