Vivani Medical (Nasdaq: VANI) announced the initiation of its first-in-human trial for a GLP-1 (exenatide) implant, using its NanoPortal drug delivery technology. The LIBERATE-1 Phase 1 trial has commenced at two centers in Australia to evaluate the implant in overweight and obese participants.
A Ground-breaking Innovation
The miniature GLP-1 implant is designed to deliver medication steadily over six months, ensuring consistent dosing and reducing the risk of fluctuating drug levels. The trial follows FDA approval of Vivani’s IND application and the lifting of a clinical hold earlier this year.
Key features of Vivani’s NanoPortal implant include:
- Steady drug release: Addresses safety concerns of inconsistent drug levels.
- Broad therapeutic potential: Capable of delivering large peptides and proteins.
- Patient convenience: Twice-yearly dosing to combat non-adherence.
LIBERATE-1 Trial Details
The trial will assess the safety, tolerability, and pharmacokinetics of the implant, with top-line data expected by mid-2025. Vivani believes its technology could provide efficacy comparable to semaglutide, a leading GLP-1 therapy, with the added convenience of long-term dosing.
Pioneering New Frontiers
“This marks a major milestone for our company,” said Adam Mendelsohn, Vivani’s CEO. “Our GLP-1 implant portfolio aims to address medication non-adherence while improving real-world health outcomes for patients.”
Vivani plans to use Australian trial data to support future regulatory submissions, including in the U.S., further advancing its position in long-term biopharmaceutical innovations.
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