Following the recent regulatory approval, Vivani Medical, Inc. (NASDAQ: VANI) has experienced a notable increase in its stock value during the current market session. At the latest observation, VANI shares surged by 13.15%, reaching $1.85 on the US stock charts.
- FDA Approval And Initialization Of Clinical Trial
- LIBERATE-1: Pioneering Clinical Study
- Advancing Innovative Drug Implants
FDA Approval And Initialization Of Clinical Trial
The FDA has approved the Investigational New Drug Application (IND) and removed the clinical hold on NPM-119, according to a statement from Vivani Medical. Vivani is developing NPM-119, a revolutionary six-month GLP-1 implant, to treat type 2 diabetes.
With this approval, the Phase 1 clinical research LIBERATE-1, aimed at evaluating the pharmacokinetics, safety, and tolerability of NPM-119, may now start. With a treatment candidate that shows promise in treating medication non-adherence—a issue that affects almost half of all type 2 diabetics—the approval is a significant step forward for Vivani Medical.
LIBERATE-1: Pioneering Clinical Study
LIBERATE-1 is Vivani Medical's first-in-human study of NPM-119 for type 2 diabetes patients and marks the initial clinical application of its groundbreaking NanoPortal implant technology. This pivotal trial will assess how the preclinical pharmacokinetic profile of NPM-119 translates to human subjects in comparison to the marketed exenatide once-weekly active comparator, Bydureon BCise.
The outcomes of LIBERATE-1 will also impact Vivani Medical's leading program, NPM-115, which is being developed for chronic weight management. Preclinical studies earlier this year demonstrated that NPM-115 could achieve weight loss comparable to semaglutide injections, the active ingredient in popular products such as Ozempic and Wegovy.
Subject to regulatory approval, the six-month dosage form of NPM-115 is poised to be a highly differentiated and appealing option in the rapidly expanding obesity market. Vivani Medical is finalizing study preparations and expects to initiate LIBERATE-1 in the latter half of the year.
Advancing Innovative Drug Implants
LIBERATE-1 is a randomized, 12-week investigation designed to assess the safety, tolerability, and comprehensive pharmacokinetic profile of NPM-119 in patients with type 2 diabetes. The trial will include patients who have previously undergone GLP-1 therapy, which will be discontinued before starting treatment with either NPM-119 or the active comparator.
近期获得监管批准后，Vivani Medical，Inc.（纳斯达克：VANI）在当前市场交易中股票价值有显著增长。最新观察显示，VANI股票价格上涨了13.15％，达到了美国股票图表上的1.85美元。
- FDA批准和临床试验启动
- LIBERATE-1：开创性的临床研究
- 推进创新药物植入
FDA批准和临床试验启动
根据Vivani Medical的声明，FDA已批准临床新药申请（IND）并取消了对NPM-119的临床暂停。 Vivani正在开发NPM-119，这是一种革命性的六个月GLP-1植入物，用于治疗2型糖尿病。该批准意味着，以检验NPM-119药代动力学，安全性和耐受性为目的的LIBERATE-1一期临床研究现在已经可以开始。凭借一个显示出治疗药物不依从性的治疗候选者——这是影响几乎所有2型糖尿病患者的问题——该批准对Vivani Medical而言是一个重要的迈进。
具有治疗药物不依从性疗效的治疗候选者是Vivani Medical的一个重要项目。该公司最先进的NanoPortal植入技术的首次临床应用是NPM-119，而LIBERATE-1则是针对2型糖尿病患者的首个人体研究。这项关键性试验将评估NPM-119的临床药代动力学特征，与市场上的exenatide一周一次活性比较剂Bydureon BCise进行比较。LIBERATE-1的结果还将影响Vivani Medical的主要项目NPM-115，该项目正在开发用于慢性体重管理。今年早些时候的临床前研究表明，NPM-115可以实现与种植semaglutide制剂相当的体重减轻，而该制剂是主流产品（例如Ozempic和Wegovy）中活性成分。在获得监管批准后，NPM-115的六个月剂型将成为迅速扩张的肥胖市场上一种高度差异化和吸引人的选项。 Vivani Medical正在完成研究准备工作，并计划在下半年开始LIBERATE-1。
LIBERATE-1：开创性的临床研究
LIBERATE-1是Vivani Medical首次针对2型糖尿病患者进行NPM-119的人体研究，并标志着其创新NanoPortal植入技术的初始临床应用。这项关键性试验将评估NPM-119的临床药代动力学特征，与市场上的exenatide一周一次活性比较剂Bydureon BCise进行比较。
LIBERATE-1的结果还将影响Vivani Medical的主要项目NPM-115，该项目正在开发用于慢性体重管理。今年早些时候的临床前研究表明，NPM-115可以实现与种植semaglutide制剂相当的体重减轻，而该制剂是主流产品（例如Ozempic和Wegovy）中活性成分。
在获得监管批准后，NPM-115的六个月剂型将成为迅速扩张的肥胖市场上一种高度差异化和吸引人的选项。Vivani Medical正在完成研究准备工作，并计划在下半年开始LIBERATE-1。
推进创新药物植入
LIBERATE-1是一项随机分组的为期12周的研究，旨在评估NPM-119在2型糖尿病患者中的安全性，耐受性和全面药代动力学特征。试验将包括此前接受过GLP-1治疗的患者，这些治疗将在开始NPM-119或活性比较剂治疗之前停止。
