HTRS2025.P1.1 Safety and efficacy of Mim8 prophylaxis in patients with hemophilia A with or without inhibitors: Results from the phase 3, open-label, randomized controlled FRONTIER2 study
Bibliographic record
Abstract
Background: Mim8 (denecimig) is a factor VIIIa mimetic bispecific antibody in clinical development for subcutaneous prophylaxis in hemophilia A (HA).Objectives: Evaluate the efficacy and safety of Mim8 in males and females (aged ≥12 years) with HA with or without inhibitors.in 5.0-12.2% of patients.There were no safety concerns and no clinical evidence of neutralizing anti-Mim8 antibodies.Conclusions: FRONTIER2 demonstrated superiority of Mim8 prophylaxis once-every-week and once-every-month in reducing ABR for treated bleeds compared with either on-demand treatment or clotting factor concentrate prophylaxis.Mim8 was well tolerated, and no safety concerns were observed.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".