Cyclarity动脉粥样硬化新药UDP-003获FDA临床试验许可：1b期试验扩至美国、预计2027年一季度启动
位于加利福尼亚州 Novato 的临床阶段生物技术公司 Cyclarity Therapeutics 11月12日宣布，美国食品药品管理局（FDA）已批准其候选药 UDP-003 的新药临床试验（IND）申请，允许把正在澳大利亚进行的1b期试验扩大到美国。
UDP-003由该公司自有的超级智能（SI）计算平台设计，旨在结合并清除氧化胆固醇，恢复细胞功能，促进动脉粥样硬化斑块消退。美国段试验编号NCT06813339（CTx-001），为多次给药、静脉注射试验，评估该药在冠状动脉疾病患者中的安全性。
该公司计划2027年第一季度在美国启动扩大后的1b期试验。（来源：Cyclarity Therapeutics）
Cyclarity's Atherosclerosis Drug UDP-003 Wins FDA IND Clearance: Phase 1b Trial Expands to the U.S., Launch Expected in Early 2027
Cyclarity Therapeutics, a clinical-stage biotechnology company based in Novato, California, announced on November 12 that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for UDP-003, authorizing the expansion of its Phase 1b trials to the United States, complementing the ongoing study in Australia.
UDP-003 is designed by the company's proprietary super intelligence (SI)-enabled computational platform to bind and extract oxidized cholesterol, restore cellular function and spur atherosclerotic plaque regression. The multi-dose, intravenous trial (NCT06813339; CTx-001) is evaluating the safety of UDP-003 in patients with coronary artery disease.
Cyclarity plans to launch the expanded Phase 1b trial in the United States in the first quarter of 2027. (Source: Cyclarity Therapeutics)
来源：Cyclarity Therapeutics
发布：GSM·美国（发布链接）
图片来源：图片来源：Wikimedia Commons「2113ab Atherosclerosis.jpg」（OpenStax College 摄，CC BY 3.0），图中为动脉粥样硬化示意图 Image: Wikimedia Commons "2113ab Atherosclerosis.jpg" (by OpenStax College, CC BY 3.0)
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