Vivani's IND Application For NPM-119 Receives FDA Approval, Lifts Clinical Hold

(RTTNews) - Vivani Medical, Inc. (VANI) announced on Thursday that the FDA has approved the Investigational New Drug or IND Application and removed the clinical hold on NPM-119 to begin the LIBERATE-1 Phase 1 clinical trial.

LIBERATE-1 is a 12-week randomized study focusing on the safety, tolerability, and complete pharmacokinetic profile of NPM-119 in patients with type 2 diabetes, who have previously used GLP-1 therapy.

Additionally, this trial will mark the initial clinical use of NanoPortal, the company's unique implant platform technology.

NPM-119 is being researched to tackle medication non-adherence and potentially enhance tolerability problems related to oral and injectable type 2 diabetes drugs by offering extended therapeutic exenatide delivery for six months.

The company plans to start LIBERATE-1 in the latter part of the year.