Wolfgang Miesbach: A Mim8 Extension Study by Pratima Chowdary’s Team Showing Robust Profile in Hemophilia A
Wolfgang Miesbach, Professor of Medicine at Frankfurt University Hospital, shared on LinkedIn:
”Promising Long-term Safety Data: Mim8 Extension Study Demonstrates Robust Profile in Hemophilia A.
Great results from the FRONTIER1 Phase 1/2 Multiple Ascending Dose (MAD) extension study show exceptional long-term safety for Mim8 (denecimig) across 69.5 patient-years of exposure in 41 patients with severe hemophilia A.
Study Design and Population:
Phase 1/2 extension study (up to 148 weeks additional treatment)
Mean age: 33.1 years (range 14-64), including 6 adolescents
90.2% without inhibitors, 9.8% with inhibitors
Outstanding Safety Profile:
Exceptional injection tolerability: Only 0.2% injection-site reaction rate (6 reactions in 3,128 injections)
Zero anti-Mim8 antibodies detected throughout extension
No thromboembolic events observed
Only 2 patients discontinued:
– 1 due to Hodgkin lymphoma (unrelated to Mim8)
– 1 due to patient decision after sequence of joint bleeds
85.4% experienced mostly mild-moderate TEAEs (unrelated to treatment)
Clinical Efficacy:
67.7% of patients on weekly dosing achieved zero bleeds
88.9% of patients on monthly dosing achieved zero bleeds
Flexible dosing options: QW (6-11mg) OR Q4W (30-46mg)
Stable thrombin generation within target range (150-200 nM)
Superior Potency Confirmed:
Mim8 achieved comparable peak thrombin generation at approximately 15-fold lower plasma concentrations than emicizumab.
This refers to the actual drug concentration needed in blood plasma to achieve similar haemostatic effect.
Next Steps:
These compelling extension data support the ongoing Phase 3 FRONTIER2 (NCT05053139) and FRONTIER3 (NCT05306418) trials, plus the planned FRONTIER4 long-term study investigating biweekly dosing options.
Congratulations to Pratima Chowdary and the international research team on these results published in RPTH Journal.”
Read the full article in RPTH.
Article: FRONTIER1 multiple ascending dose extension: a safety, tolerability, pharmacokinetics, and pharmacodynamics study of Mim8 in patients with haemophilia A
Authors: Pratima Chowdary, Steven R. Lentz, Lidia Gil, Francisco J. López-Jaime, Jerzy Windyga, Wan Hui Ong Clausen, Peter Nørkjær Laursen, Johnny Mahlangu
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