ArticleResearch and practice in thrombosis and haemostasis2025
FRONTIER1 multiple ascending dose extension: a safety, tolerability, pharmacokinetics, and pharmacodynamics study of Mim8 in people with hemophilia A.
Article in Research and practice in thrombosis and haemostasis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04204408 (Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Subcutaneous Doses of NNC0365-3769), which is not on this map. Not yet cited in PubMed.
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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Subcutaneous Doses of NNC0365-3769 (Mim8) in Healthy Subjects and in Subjects With Haemophilia A With or Without Factor VIII Inhibitors
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8 authors.
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Abstract
Background: Mim8 (denecimig) is a next-generation, factor VIIIa mimetic, human bispecific antibody for hemophilia A. Mim8 was well tolerated in the phase 1/2 FRONTIER1 (NCT04204408) dose-escalation part. Objectives: Report Mim8 long-term safety in the FRONTIER1 multiple ascending dose (MAD) extension phase. Methods: People (≥12 years) with severe hemophilia A with/without inhibitors who completed the 12-week FRONTIER1 MAD main phase enrolled in the extension and continued Mim8 once weekly or once every 4 weeks for up to 148 weeks; patients could switch doses or transition to maintenance doses designed to achieve target exposure in phase 3 trials. Primary endpoint: treatment-emergent adverse events (TEAEs). Secondary endpoints: injection-site reactions, anti-Mim8 antibodies. Results: Forty-one patients entered the extension; Conclusion: Mim8 was well tolerated, with no safety concerns nor anti-Mim8 antibodies during the FRONTIER1 MAD extension, supporting phase 3 development of Mim8 once weekly and once every 4 weeks.
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