Vivani Medical has commenced the first-in-human, randomised trial, LIBERATE-1, by initiating screening and enrolment to assess the pharmacokinetic and safety profile of its exenatide NanoPortal drug implant technology, in obese and overweight subjects in Australia.
The study aims to assess the implant in these subjects, who will undergo an eight-week titration period on weekly semaglutide injections. The subjects will then be randomised to receive a single administration of the implant, weekly exenatide injections, or weekly semaglutide injections for a treatment period of nine weeks.
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This study will measure weight changes, with top-line data expected by mid-next year.
The company plans to leverage research and development incentives from the Australian Government to offset some of the clinical trial costs. The data generated in the country will be used to support regulatory submissions in various regions, including the US.
Vivani Medical president and CEO Adam Mendelsohn said: “Transitioning to a clinical-stage biopharmaceutical company is a major milestone for our company and allows us to determine if the very encouraging results from our animal studies will translate to overweight or obese study subjects.
“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, but with the significant benefit of twice-yearly administration.”
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By GlobalDataThe NanoPortal platform is central to the company’s strategy, enabling the development of biopharmaceutical implants that release drug molecules steadily over time. This approach claims to ensure medication adherence, enhance convenience, and potentially improve patient tolerance.
Additionally, the company’s lead candidate, NPM-115, leverages a six-month subdermal GLP-1 (exenatide) implant being developed for chronic weight management in obese or overweight patients.
Vivani’s pipeline also includes NPM-139, a semaglutide implant for the same indication.
In September, the company secured approval from the Bellberry Human Research Ethics Committee to initiate the first-in-human clinical trial in Australia for its GLP-1 implant.
