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.
近期獲得監管批准後，Vivani Medical，Inc.（納斯達克：VANI）在當前市場交易中股票價值有顯著增長。最新觀察顯示，VANI股票價格上漲了13.15％，達到了美國股票圖表上的1.85美元。
- FDA批准和臨床試驗啓動
- LIBERATE-1：開創性的臨床研究
- 推進創新藥物植入
FDA批准和臨床試驗啓動
根據Vivani Medical的聲明，FDA已批准臨床新藥申請（IND）並取消了對NPM-119的臨床暫停。 Vivani正在開發NPM-119，這是一種革命性的六個月GLP-1植入物，用於治療2型糖尿病。該批准意味着，以檢驗NPM-119藥代動力學，安全性和耐受性爲目的的LIBERATE-1一期臨床研究現在已經可以開始。憑藉一個顯示出治療藥物不依從性的治療候選者——這是影響幾乎所有2型糖尿病患者的問題——該批准對Vivani Medical而言是一個重要的邁進。
具有治療藥物不依從性療效的治療候選者是Vivani Medical的一個重要項目。該公司最先進的NanoPortal植入技術的首次臨床應用是NPM-119，而LIBERATE-1則是針對2型糖尿病患者的首個人體研究。這項關鍵性試驗將評估NPM-119的臨床藥代動力學特徵，與市場上的exenatide一週一次活性比較劑Bydureon BCise進行比較。LIBERATE-1的結果還將影響Vivani Medical的主要項目NPM-115，該項目正在開發用於慢性體重管理。今年早些時候的臨床前研究表明，NPM-115可以實現與種植semaglutide製劑相當的體重減輕，而該製劑是主流產品（例如Ozempic和Wegovy）中活性成分。在獲得監管批准後，NPM-115的六個月劑型將成爲迅速擴張的肥胖市場上一種高度差異化和吸引人的選項。 Vivani Medical正在完成研究準備工作，並計劃在下半年開始LIBERATE-1。
LIBERATE-1：開創性的臨床研究
LIBERATE-1是Vivani Medical首次針對2型糖尿病患者進行NPM-119的人體研究，並標誌着其創新NanoPortal植入技術的初始臨床應用。這項關鍵性試驗將評估NPM-119的臨床藥代動力學特徵，與市場上的exenatide一週一次活性比較劑Bydureon BCise進行比較。
LIBERATE-1的結果還將影響Vivani Medical的主要項目NPM-115，該項目正在開發用於慢性體重管理。今年早些時候的臨床前研究表明，NPM-115可以實現與種植semaglutide製劑相當的體重減輕，而該製劑是主流產品（例如Ozempic和Wegovy）中活性成分。
在獲得監管批准後，NPM-115的六個月劑型將成爲迅速擴張的肥胖市場上一種高度差異化和吸引人的選項。Vivani Medical正在完成研究準備工作，並計劃在下半年開始LIBERATE-1。
推進創新藥物植入
LIBERATE-1是一項隨機分組的爲期12周的研究，旨在評估NPM-119在2型糖尿病患者中的安全性，耐受性和全面藥代動力學特徵。試驗將包括此前接受過GLP-1治療的患者，這些治療將在開始NPM-119或活性比較劑治療之前停止。
