FRONTIER1 multiple ascending dose extension: a safety, tolerability, pharmacokinetics, and pharmacodynamics study of Mim8 in people with hemophilia A.

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 antibodi

SUBMITTER: Chowdary P 

PROVIDER: S-EPMC12617623 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature