Akari Therapeutics Receives FDA Feedback, Paving the Way for New Eye Disease Treatment
Akari Therapeutics Receives FDA Feedback, Paving the Way for New Eye Disease Treatment
The regulatory feedback from the FDA and production of GMP material enables a clear path forward to submitting an IND, with the IND expected to be submitted in 2025.Akari Therapeutics announced today that the company has received positive and constructive Pre-IND (PIND) feedback from the FDA on July 29, 2024, which provides additional clarity on Akari's final Investigational New Drug Application (IND)- enabling preclinical plans, drug manufacturing and Phase 1 clinical strategy for long-acting PAS-nomacopan for intravitreal treatment of geographic atrophy (GA).
2024年7月29日，Akari Therapeutics宣佈公司已收到FDA有關PAS-nomacopan長效治療地理萎縮（GA）眼內注射藥物製造業半導體制造業-半導體的臨床策略的Pre-IND（PIND）正面和建設性反饋，進一步明確了Akari的最終IND申請所需的前臨床計劃、藥物製造和Phase 1臨床策略。
PAS-nomacopan is a long-acting bispecific inhibitor of C5 and leukotriene B4 (LTB4) product candidate that Akari believes has the potential for longer dose intervals between intravitreous injections than currently approved complement only inhibitors, as well as potential reduction of the choroidal neovascularization (CNV) risk that is associated with approved inhibitors. CNV is a sight-threatening over development of blood vessels within the retina, which is typically treated with additional anti-vascular endothelial growth factor (VEGF) intravitreal injections.
PAS-nomacopan是一種長效C5和白三烯B4（LTB4）雙特異性抑制劑，Akari Therapeutics認爲它具有比目前批准的僅抑制劑劑量間隔更長的潛力，同時還能減少與批准抑制劑相關的脈絡膜新生血管（CNV）風險。CNV是視網膜內血管過度發展，常用額外的抗血管內皮生長因子（VEGF）眼內注射治療。
A full-scale batch of drug substance was recently successfully manufactured and released under applicable Good Manufacturing Practices (GMP) conditions by our manufacturing partner, Wacker Biotech GmbH, and is planned to be used for both the final IND-enabling studies and initial clinical development.
我們的製造夥伴Wacker Biotech GmbH最近成功製造了一批符合適用良好製造規範（GMP）條件的藥物物質，並計劃將其用於最終的IND-enabling研究和初步臨床開發。
The regulatory feedback from the FDA and production of GMP material enables a clear path forward to submitting an IND, with the IND expected to be submitted in 2025.
FDA的監管反饋和GMP物料的生產爲提交IND開闢了明確的道路，預計2025年提交IND。
譯文內容由第三人軟體翻譯。