EXCLUSIVE: Vivani Medical Advances Its Obesity Treatment Implant With New Clinical Trial in Australia

On Thursday, Vivani Medical, Inc. VANI announced that the Bellberry Human Research Ethics Committee has approved, and the Therapeutic Goods Administration in Australia has formally acknowledged a first-in-human clinical trial of the company's miniature, subdermal GLP-1 (exenatide) implant in obese and overweight subjects.

What Happened: "Securing regulatory approval keeps us on schedule to initiate this trial in Australia in the fourth quarter of 2024," said Vivani President and CEO Adam Mendelsohn.

Also Read: EXCLUSIVE: Vivani Medical Outlines Plans To Kickstart First Clinical Study For Miniature GLP-1 Obesity Implant Program This Year.

LIBERATE-1 will be a randomized investigation of the safety, tolerability, and pharmacokinetic profile of the exenatide NanoPortal implant in obese or overweight subjects.

The trial will enroll participants who will be titrated on weekly semaglutide injections for 8 weeks (0.25 mg/week for 4 weeks followed by 0.5 mg/week for 4 weeks) before being randomized to receive a single administration of Vivani's exenatide implant (n=8), weekly exenatide injections (n=8), or weekly 1 mg semaglutide injections (n=8) for 9-week treatment duration.

Weight changes will be measured. The trial is expected to be initiated later this year, and data is projected to be available in 2025.

Why It Matters: "Preclinical weight loss and liver fat data announced earlier this year supports the potential for our GLP-1 implant to provide comparable efficacy to semaglutide, the active ingredient in blockbuster products Ozempic and Wegovy, but with the significant benefit of twice-yearly administration," Mendelsohn added.

Ozempic and Wegovy are registered trademarks of Novo Nordisk A/S NVO.

If available, Vivani intends to utilize research and development incentives and rebates from the Australian government to defray a portion of the costs from the trial.

Since clinical studies conducted in Australia comply with the International Conference on Harmonization guidelines and data generated in Australia are generally acceptable to the FDA and other regulatory authorities, Vivani anticipates using relevant clinical data generated in Australia to support regulatory submissions in other geographies, including the U.S.

Price Action: VANI stock closed at $1.18 on Wednesday.

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