Heart failure & cardiomyopathies
The ADESTE Trial: A Phase 2 Study of Enibarcimab, a Monoclonal Antibody Targeting Adrenomedullin, in Acute Heart Failure
Authors' conclusion
In this pilot safety study of patients hospitalized for AHF, IV infusion of EN 0.5 and 2 mg/kg increased circulating plasma bio-ADM levels and was well-tolerated without treatment-related SAEs occurring during hospitalization and up to 90 days after discharge.
Study context
- Population
- Patients hospitalized for acute heart failure (AHF)
- Participants
- 10 / 10 / 10
- Exposure
- SoC + EN vs SoC alone
- SoC + EN 0.5 mg/kgn = 10
- SoC + EN 2 mg/kgn = 10
- Control groupn = 10
- Outcome
- Plasma bio-ADM levels
- Follow-up
- Within 24 h post-infusion
Methodological detailsphase 2 proof-of-concept and safety study, two cardiology sites in Indonesia
- Phase 2 proof-of-concept and safety study
- Two cardiology sites in Indonesia
Main finding
As reported in the abstract
- EN led to a significant increase in plasma bio-ADM levels; SoC + 2 mg/kg group showing the highest increase
Observational data: associations, not effects.
Further findings
Percentage reduction in systolic, diastolic blood pressure, and mean arterial pressure · Within 1 h from intravenous (IV) EN infusion
- SoC + EN 2 mg/kg compared with 0.5 mg/kg resulted in a significant percentage reduction; did not result in severe hypotension and the need for drug discontinuation
Safety
| Outcome | SoC + EN 0.5 mg/kg | SoC + EN 2 mg/kg | Control group |
|---|---|---|---|
| Serious adverse events (SAEs) · during hospitalization and up to 90 days after dischargeDeemed not related to treatment | 10% | 10% | — not stated in the abstract |
| Deaths | — not stated in the abstract | 20% | 30% |
— not stated in the abstract
Serious adverse events (SAEs) · during hospitalization and up to 90 days after discharge
- No significant differences in the occurrence of SAEs between the groups
Deaths
- Five deaths occurred
Original publication
The ADESTE Trial: A Phase 2 Study of Enibarcimab, a Monoclonal Antibody Targeting Adrenomedullin, in Acute Heart Failure. ESC Heart Fail. Published 14 January 2025. doi:10.
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