ArticleResearch and practice in thrombosis and haemostasis2023
Mim8, a novel factor VIIIa mimetic bispecific antibody, shows favorable safety and pharmacokinetics in healthy adults.
Article in Research and practice in thrombosis and haemostasis, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 15 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of Reformulated NNC0365-3769 (Mim8) in Healthy Male Participants
Who cites it
15 citing papers in PubMed.
- Denecimig (Mim8) prophylaxis over 52 weeks in adolescents and adults with hemophilia A: FRONTIER2 extension study.Research and practice in thrombosis and haemostasis · 2026Trial
- Personalized Treatment of Hemophilia: Matching Therapies to Patient Needs in a Rapidly Evolving Landscape.Drugs · 2026Review
- Divergent molecular strategies of next-generation activated factor VIII mimetics: insights from a direct comparative analysis.Research and practice in thrombosis and haemostasis · 2026Article
- Non-factor Therapies in Hemophilia: Mechanisms, Clinical Evidence, Patient Management, and Future Perspectives.Advances in therapy · 2026Review
- Factor VIIIResearch and practice in thrombosis and haemostasis · 2026Article
- ComparativeResearch and practice in thrombosis and haemostasis · 2025Article
- FRONTIER1 multiple ascending dose extension: a safety, tolerability, pharmacokinetics, and pharmacodynamics study of Mim8 in people with hemophilia A.Research and practice in thrombosis and haemostasis · 2025Article
- Protease engineering: Approaches, tools, and emerging trends.Biotechnology advances · 2025Review
- Economic Burden of Haemophilia from a Societal Perspective: A Scoping Review.PharmacoEconomics - open · 2025Review
- Factor VIII Activity and Factor VIII Inhibitors Can Be Measured Accurately in Plasma Containing Mim8 by Using Specific Chromogenic Assays.Haemophilia : the official journal of the World Federation of Hemophilia · 2025Article
- Contemporary approaches to treat people with hemophilia: what's new and what's not?Research and practice in thrombosis and haemostasis · 2025Review
- Advances in Development of Drug Treatment for Hemophilia with Inhibitors.ACS pharmacology & translational science · 2024Review
- Exploring nonreplacement therapies' impact on hemophilia and other rare bleeding disorders.Research and practice in thrombosis and haemostasis · 2024Article
- In vivo LNP-CRISPR Approaches for the Treatment of Hemophilia.Molecular diagnosis & therapy · 2024Review
- The Dilemma of Providing Advanced Hemophilia Treatments in Developing Countries - For Whom, by Whom and Where?Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/HemostasisReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Mim8 (denecimig) is a novel activated coagulation factor VIII-mimetic bispecific antibody that assembles with activated coagulation FIX and FX on the platelet membrane surface. Objectives: The FRONTIER1 (NCT04204408, NN7769-4513) single ascending dose and the 4882 pharmacokinetic (PK) studies (NCT05127473, NN7769-4882) examined the safety, tolerability, PK, and pharmacodynamics (PD) of Mim8 in healthy adult males. Methods: The FRONTIER1 single ascending dose study consisted of 6 cohorts, each with 6 participants who received a single subcutaneous (s.c.) dose of Mim8 and 2 participants who received a placebo. The 4882 PK study had 11 arms, each with 6 participants who received a single s.c. dose of Mim8. The primary endpoint for both studies was treatment-emergent adverse events. Other safety assessments included relative changes in D-dimer, prothrombin fragments 1 and 2, fibrinogen, and platelets. The PK and PD were assessed using Mim8 plasma concentration and activated partial thromboplastin clotting time and thrombin generation, respectively. Results: Mim8 was well tolerated, and there were no severe treatment-emergent adverse events. The PK properties of Mim8 in both studies were consistent with dose-proportionality. The terminal half-life of Mim8 after a single dose was approximately 1 month, and maximum plasma concentration was reached after 10 days. Conclusion: The PK and PD profiles suggest that Mim8 is suitable as a long-acting FVIIIa-mimetic bispecific antibody for hemophilia A prophylaxis.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.