Vivani Medical Announces Positive Top-Line Results from SLIM-1™, a First in Human Phase 1 Trial of NPM-139 (semaglutide implant) and Wegovy (weekly semaglutide injections) in Obese and Overweight Subjects
Key Highlights
- ➤NPM-139 treatment-related adverse events: 0 of 10 subjects
- ➤Wegovy treatment-related adverse events: 5 of 10 subjects
- ➤NPM-139 maximum drug levels reached ~16 days versus ~2.4 days for Wegovy
- ➤Comparable weight loss: 0.79% NPM-139 versus 0.82% Wegovy
- ➤Vivani plans a Phase 2 dose-ranging weight maintenance trial in 2027
Expert Statements
Adam Mendelsohn, CEO of Vivani Medical
“The positive top-line data from our SLIM-1 Phase 1 trial marks a critical milestone for Vivani, demonstrating encouraging clinical translation from preclinical models to humans, an encouraging delivery profile, and a strong tolerability profile.”
Adam Mendelsohn, CEO of Vivani Medical
“Real-world data show a staggering level of GLP-1 therapy dropoff.”
Adam Mendelsohn, CEO of Vivani Medical
“By some estimates, more than 50% of GLP-1 users discontinue their therapy within a single year, with gastrointestinal side effects driving much of this attrition.”
Adam Mendelsohn, CEO of Vivani Medical
“The long-term health outcomes and related pharmacoeconomic value that have been associated with GLP-1 therapy are only realized when patients remain on treatment for durations significantly longer than one year.”
Adam Mendelsohn, CEO of Vivani Medical
“The absence of rapid drug exposure increases from the NPM-139 group is both desirable and reassuring because rapid increases in drug concentrations have been associated with tolerability issues with other GLP-1 therapies.”
Adam Mendelsohn, CEO of Vivani Medical
“The strong NPM-139 safety and tolerability profile in SLIM-1 reinforces our belief that NPM-139 may directly address a major reason for attrition in GLP-1 therapies, while simultaneously improving medication adherence and convenience for patients.”
Adam Mendelsohn, CEO of Vivani Medical
“We don’t know of any other company that is developing miniature, ultra-long-acting, GLP-1 implants that make possible a once- or twice-yearly administration frequency, with the reversibility speed of a weekly injection.”
Adam Mendelsohn, CEO of Vivani Medical
“We expect that quick reversibility will be a compelling feature for certain segments of the GLP-1 market who would like an ultra-long-acting option but would need one that offers quick reversibility, including the approximately 23% of GLP-1 users who are women of child-bearing age due to recommendations against continued GLP-1 use during pregnancy.”
Gregg Williams, Chairman of the Board of Vivani Medical
“I’m very excited about the new top-line SLIM-1 data released today and continue to believe these miniature, ultra-long-acting drug implants have the potential to revolutionize the treatment of chronic diseases including obesity and type 2 diabetes.”
-0 of 10 NPM-139 subjects experienced adverse events reported as treatment related -5 of 10 Wegovy subjects (control group) experienced adverse events reported as treatment related (gastrointestinal only, consistent with marketed GLP-1 therapies)
-No NPM-139 rapid drug exposure increases; maximum drug levels from a single administration measured at ~16 days (versus ~2.4 days for the Wegovy control group) -NPM-139 semaglutide delivery was encouraging and consistent with preclinical performance -Comparable weight loss was observed between the NPM-139 and Wegovy groups
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