EXCLUSIVE: Vivani Medical Initiates First Human Clinical Trial With GLP-1 Implant For Weight Loss In Australia
EXCLUSIVE: Vivani Medical Initiates First Human Clinical Trial With GLP-1 Implant For Weight Loss In Australia
On Thursday, Vivani Medical Inc. (NASDAQ:VANI) initiated screening and enrollment at two centers in Australia for the first-in-human clinical trial, LIBERATE-1.
週四，Vivani 醫療有限公司（納斯達克：VANI）在澳洲的兩個中心啓動了首個人體臨床試驗的篩選和登記，試驗名爲 LIBERATE-1。
The trial investigates the safety, tolerability, and full pharmacokinetic profile of an exenatide implant.
該試驗旨在研究一種艾塞那肽植入物的安全性、耐受性和完整的藥代動力學特徵。
Vivani's lead program, NPM-115, utilizes a miniature, six-month, subdermal, GLP-1 (exenatide) implant under development for chronic weight management in obese or overweight individuals.
Vivani 的主導項目 NPm-115，利用一種微型六個月的皮下 GLP-1（艾塞那肽）植入物，正在開發用於肥胖或超重個體的慢性體重管理。
Also Read: EXCLUSIVE: Vivani Medical Reveals Positive Preclinical Liver Fat Results From Miniature GLP-1 Implant For Obesity
另請閱讀：獨家：Vivani 醫療公司透露微型 GLP-1 植入物在肥胖症中預臨床肝脂肪結果積極
The study is the first clinical application of the company's proprietary NanoPortal drug implant technology.
該研究是公司專有的 NanoPortal 藥物植入技術的首個臨床應用。
In September, the Bellberry Human Research Ethics Committee approved, and the Therapeutic Goods Administration in Australia formally acknowledged a first-in-human clinical trial of the company's miniature, subdermal GLP-1 (exenatide) implant in obese and overweight subjects.
在九月，Bellberry 人類研究倫理委員會批准，澳洲的治療商品管理局正式承認該公司微型皮下 GLP-1（艾塞那肽）植入物在肥胖和超重受試者中的首個人體臨床試驗。
The trial will enroll participants who will be titrated on weekly semaglutide injections for 8 weeks before being randomized to receive a single administration of Vivani's exenatide implant (n=8), weekly exenatide injections (n=8), or weekly 1 mg semaglutide injections (n=8) for 9-week treatment duration.
該試驗將招募參與者，在隨機接受 Vivani 的艾塞那肽植入物（n=8）、每週艾塞那肽注射（n=8）或每週 1 毫克美克來君注射（n=8）之前，進行 8 周的每週美克來君注射。
Weight changes will be measured. The company anticipates that top-line data will be available in mid-2025.
將測量體重變化。該公司預計在 2025 年中期將提供頂線數據。
If available, Vivani intends to utilize research and development incentives and rebates from the Australian government to defray some of the costs from this clinical trial.
如果可行，Vivani打算利用澳洲政府的研發激勵和退稅來抵消部分臨床試驗的費用。
Since clinical studies conducted in Australia comply with the International Conference on Harmonization guidelines, data generated in Australia are generally acceptable to the FDA and other regulatory authorities.
由於在澳洲進行的臨床研究符合國際協調會議的指南，在澳洲產生的數據通常被FDA和其他監管機構接受。
Vivani anticipates using relevant clinical data generated in Australia to support regulatory submissions in other geographies, including the U.S.
Vivani預計將利用在澳洲產生的相關臨床數據來支持在其他地區的監管提交，包括美國。
Vivani's pipeline also includes NPM-139 (semaglutide implant), which is also under development for chronic weight management in obese and overweight individuals.
Vivani的產品線還包括NPm-139（半胱氨酸植入劑），該產品也正在開發用於肥胖和超重個體的慢性體重管理。
Price Action: VANI stock is up 0.83% at $1.22 during the premarket session at last check on Thursday.
價格動態：在上週四的盤前交易中，VANI股票上漲0.83%，報1.22美元。
- Teva Pharmaceutical Releases Impressive Phase 2 Candidate Data For Gastro-Related Diseases
- Teva 藥品發佈了令人印象深刻的第二階段候選者數據，針對與消化系統相關的疾病。
譯文內容由第三人軟體翻譯。