Phase II success for Arzerra (GSK/Genmab) for MS
Genmab A/S/GSK has announced top-line results from a Phase II study of the subcutaneous formulation of Arzerra (ofatumumab) in relapsing-remitting Multiple Sclerosis (RRMS). A total of 232 subjects with RRMS were randomized in the study. There was a clear separation from placebo on the cumulative number of new gadolinium enhancing lesions (active brain lesions) over a period of 12 weeks in subjects treated with all doses of ofatumumab compared to subjects treated with placebo [p < 0.001]. For the primary endpoint, analysis of data from weeks 0-12 estimated a 65% reduction in the cumulative number of new T1 gadolinium enhancing lesions for all doses [p < 0.001]. In weeks 4-12, analyses of data estimated a more than 90% reduction in the cumulative number of new T1 gadolinium enhancing lesions for all cumulative doses of ofatumumab more than 30 mg [p < 0.001]. There were no unexpected safety findings in the study.
From weeks 0-12, injection related reactions were the most common adverse reaction and were observed in 52% of subjects receiving ofatumumab compared to 15% of subjects receiving placebo. There were five serious adverse events (SAEs) reported, all subjects received a 60 mg dose of ofatumumab and none of these subjects withdrew from the study. Twelve subjects withdrew during this time period; 10 of these subjects were receiving ofatumumab. To date, no cases of progressive multifocal leukoencephalopathy (PML) or opportunistic infections have been observed.
Related news and insights
Regeneron Pharmaceuticals, Inc. announced the FDA as accepted for review the Eylea (aflibercept) Injection supplemental Biologics License Application (sBLA) for an every 16-week 2 mg dosing regimen (after initial monthly doses) in patients with diabetic retinopathy (DR). The target action date for the FDA decision is February 28, 2023.
VBI Vaccines Inc. a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, announced that new data from a follow-up analysis of a subset of participants from the pivotal Phase III study (PROTECT) of the Company’s 3-antigen prophylactic hepatitis B (HBV) vaccine, were presented in an oral presentation at The International Liver Congress 2022 (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL), which took place on June 26, 2022.