Akshat Jain: Thrombin Generation and Factor VIII Equivalence With Mim8
Akshat Jain, Hematology Pediatric Workforce Task Force at American Society of Hematology, shared a post on LinkedIn about a recent article by Tadashi Matsushita et al., published in Blood Advances, adding:
“Treatment burden is one of the biggest day-to-day challenges for people living with hemophilia A. Fewer injections without giving up bleed protection is the goal, so I was glad to see these results from FRONTIER4 in Blood Advances (Matsushita et al.).
Unanswered questions:
- Detailed information on Q4Week ABR data would be useful.
- Why the FDA setback to Novo Nordisk, if the data looks good , remains an ambiguity ? Manufacturing ?safety? Scaling up ?
- Median ABR data and HJHS in recipient’s meaningful end points we would love to see in this and all MIM8 cohort.
- What does factor 8 equivalency look for this mimetic agent ?
The study: 37 people with hemophilia A, with or without inhibitors, had previously been on denecimig in the FRONTIER1 extension. They moved to dosing once every two weeks (Q2W) for 26 weeks.
What they found:
- Mean annualized bleed rate (ABR) of 0.38
- 83.8% of patients had zero treated bleeds
- Injection-site reactions in 2.9% of injections (14 of 484), across 2 patients
- Adverse events were mild to moderate, and none led to discontinuation
- No thromboembolic events
- No clinical evidence of neutralizing antibodies
Why it matters: Q2W dosing sits between the weekly and monthly options, which gives patients and clinicians more room to match a regimen to a person’s life and preferences. Bleed protection looked strong, and the safety profile showed no new concerns.
Context: This is an interim, open-label analysis of a small cohort that was already familiar with the drug, so longer follow-up and broader populations will matter. Part 2 of FRONTIER4 is evaluating weekly, Q2W and monthly dosing over the long term.
Unanswered questions
- Q4Week dose cohort ABR data would be very exciting to see
- What prompted the FDA setback to Novo Nordisk ? if the data looks good , what really delayed the PDUFA ? Manufacturing ?safety? Scaling up ?
- Median ABR data and HJHS in these recipient’s are meaningful end points I would look forward to review in this and all MIM8 cohort’s.
- What would the factor 8 equivalency look like in recipient’s of Mim8 ?
- Thrombin Generation data.”
Title: Denecimig (Mim8) prophylaxis once every 2 weeks for hemophilia A with or without inhibitors: 26-week results from FRONTIER4
Authors: Tadashi Matsushita, Atanas Banchev, Julien Bovet, Pratima Chowdary, Llenalia María García Fernández, Víctor Jiménez-Yuste, Kaan Kavakli, Johanna A. Kremer Hovinga, Jerzy Windyga, Guy Young
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