Edesa Biotech获FDA放行 白癜风二期研究IND获批将扩展至美国临床点
多伦多讯——临床阶段生物制药公司Edesa Biotech, Inc.（纳斯达克：EDSA）10月15日经GlobeNewswire宣布，美国食品药品监督管理局（FDA）已批准其研究性新药（IND）申请，公司可将正在进行的白癜风临床研究扩展至美国临床研究点。
白癜风是一种自身免疫性皮肤病，患者因色素细胞受损而出现白色斑块，目前获批疗法有限；IND获批意味着FDA已许可该药物在美国受试者中开展临床试验。据公司公告，该二期研究的顶线数据预计于2027年第四季度公布。Edesa Biotech总部位于加拿大多伦多，专注于免疫相关疾病领域的临床开发，此次IND获批使该白癜风项目得以在美国增设研究中心、扩大受试者招募范围。
Edesa Biotech Wins FDA IND Clearance to Expand Phase 2 Vitiligo Study to U.S. Sites
TORONTO — Edesa Biotech, Inc. (Nasdaq: EDSA), a clinical-stage biopharmaceutical company, announced on October 15 via GlobeNewswire that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application, enabling the expansion of its ongoing vitiligo clinical study to U.S. investigational sites.
Vitiligo is an autoimmune skin condition in which pigment-producing cells are damaged, causing white patches on the skin, and approved treatment options remain limited; clearance of an IND authorizes a drug to be tested in US trial participants. Topline data from the Phase 2 study are anticipated in the fourth quarter of 2027, the company said. Edesa, headquartered in Toronto, focuses on clinical development in immune-related diseases; the clearance allows the vitiligo program to add U.S. sites and broaden patient recruitment.
发布：GSM·美国（发布链接）
图片来源：Edesa Biotech 公司官方标识（公司官网） / Edesa Biotech official logo (company website)
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