other material
confidence high
sentiment positive
materiality 0.65
Vivani Medical gets Australian approval to start first-in-human GLP-1 implant trial LIBERATE-1
Vivani Medical, Inc.
- Approval from Bellberry HREC and TGA acknowledgement for LIBERATE-1 trial in obese/overweight subjects.
- Trial will evaluate safety, tolerability, and PK of exenatide NanoPortal implant in 24 participants.
- Preclinical data suggests comparable efficacy to semaglutide with twice-yearly dosing.
- Enrollment expected Q4 2024; data projected in 2025; Australian R&D incentives may defray costs.
- Data intended to support regulatory submissions in the US and other geographies.