Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AGN-151607 · 1 trial · 1 indication
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
| Arm | Type | Description |
|---|---|---|
| AGN-151607 (250 U) | EXPERIMENTAL | Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
| AGN-151607 (125 U) | EXPERIMENTAL | Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
| Placebo | PLACEBO_COMPARATOR | Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
| Name | Type | Description |
|---|---|---|
| AGN-151607 | DRUG | Injections were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
| Placebo | DRUG | Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
Inclusion Criteria: Inclusion Criteria: * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form. * Written informed consent from the participant has been obtained prior to any study-related procedures * Writt...
AGN-151607 is an investigational small molecule developed by AbbVie Inc. (ticker ABBV) for the prevention of post-operative atrial fibrillation, a common heart rhythm complication after open-chest cardiac surgery. It was studied in a Phase 2 clinical trial and has not been approved by the FDA.
AGN-151607 is being developed to prevent post-operative atrial fibrillation in adult patients undergoing open-chest cardiac surgery. The intended use is reducing this arrhythmia complication around the time of surgery. It is investigational and has not been approved for any indication.
AGN-151607 targets SNARE, a protein complex involved in vesicle fusion and neurotransmitter release. By acting on this target, the small molecule is designed to modulate nerve signaling relevant to the heart's electrical activity after cardiac surgery.
AGN-151607 is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie holds the asset and sponsored the clinical program evaluating the drug in cardiac surgery patients.
AGN-151607 is in Phase 2 development. It is investigational and has not been approved by the FDA. The completed Phase 2 trial enrolled 323 participants and evaluated the drug for preventing post-operative atrial fibrillation after open-chest cardiac surgery.
AGN-151607 was studied in the Phase 2 NOVA trial, registered as NCT03779841, titled Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Adult Participants Undergoing Open-chest Cardiac Surgery. The trial is completed, was randomized, double-blind, and placebo-controlled, and enrolled 323 participants across the United States, Austria, Canada, Germany, Italy, Netherlands, Spain, Sweden, and the United Kingdom.