NXT007 prophylaxis in people with haemophilia A with or without FVIII inhibitors: a global phase I/II multiple-ascending-dose study.

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Authors: Maria Elisa Mancuso, Davide Matino, Daniel P. Hart, Francisco José López‐Jaime, Christophe Schmitt, Amy D. Shapiro, Giuliana Ventriglia, A Kiialainen, L Young, Olivier Catalani, Mark Belletrutti, T Chu
+4 more Jerzy Windyga, Víctor Jiménez‐Yuste, Michaela Lehle, Janice M.R. Staber
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Abstract

Introduction NXT007 is a next-generation bispecific antibody, based on emicizumab, that mimics the cofactor function of activated factor (F)VIII to restore intrinsic tenase activity in people with haemophilia A (PwHA). Here, we report on the first three cohorts of the Phase I/II global multiple ascending dose (MAD) study of NXT007 (NCT05987449) in PwHA. Method The global MAD study of NXT007 is an open-label, non-randomised, multicentre trial. Eligible participants (pts) are males aged 12–59 years with severe (FVIII activity

Fields of Study & Subjects

Hemophilia Treatment and Research Platelet Disorders and Treatments Coagulation Bradykinin Polyphosphates and Angioedema

Publication details

Journal / source
Hämostaseologie
Volume
46
Issue
S 01
Pages
S48–S49
Publication date
1 February 2026
Language
DE