Vivani Medical Inc. (NASDAQ:VANI) on Tuesday reported results from the LIBERATE-1 Phase 1 study of the exenatide GLP-1 implant NPM-115, representing the first-in-human test of the company's proprietary NanoPortal implant technology.
Exenatide is sold by AstraZeneca Plc (NASDAQ:AZN) under the brand names Byetta and Bydureon BCise to treat type 2 diabetes.
LIBERATE-1 Study Results
The study met its primary objectives, which were to evaluate the NPM-115 implant's safety and tolerability profile and to characterize the pharmacokinetic (PK) profile of the implant over a 9-week duration.
Throughout the study, the implant was generally well tolerated, and drug release from the implant without any clinically meaningful burst was supported by PK analysis and by the absence of gastrointestinal adverse events in subjects with the implant.
No serious adverse events were observed in the study.
The release profile observed from the implants over 9 weeks encourages the potential for the technology to provide durable delivery over the 6-month duration that has already been established in preclinical studies of both NPM-115 and NPM-139.
Semaglutide Implant Preclinical Feasibility Data
The company also reported new feasibility data for NPM-139 (semaglutide implant) from an ongoing preclinical study, supporting prioritization of the semaglutide implant in the company's pipeline and clinical development strategy.
Semaglutide is the active ingredient in Novo Nordisk A/S' (NYSE:NVO) blockbuster drug products Ozempic, Wegovy, and Rybelsus.
In an ongoing preclinical study, substantial progress in developing a miniature, ultra-long-acting, semaglutide implant, NPM-139, has been established by showing weight loss from a single administration for over 231 days.
While the emerging preclinical data on the company's semaglutide implant currently supports the initial target profile of bi-annual dosing, the company continues to anticipate that a semaglutide implant candidate may be able to support annual dosing in the future.
Vivani's near-term efforts are focused on completing PK optimization activities and data preparation to enable the submission of an Investigational New Drug application for NPM-139.
The decision to prioritize NPM-139 is supported by several factors.
The company believes that the development timelines for the NPM-115 and NPM-139 programs are comparable, with increased confidence in NPM-139 because semaglutide products have already established compelling weight loss data in humans.
Vani also highlights a strong commercial performance of semaglutide-based products, which have generated over $29 billion in sales in 2024.
Price Action: At the last check Tuesday, VANI stock was up 3.57% at $1.45 during the premarket session.
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