机器翻译自 NAAF eNews April 2025
Q32 Bio announced that it has received a Fast Track designation for
bempikibart, its investigational treatment for alopecia areata (AA),
currently under investigation in a Phase 2B clinical trial program.
According to the U.S. Food and Drug Administration (FDA), Fast Track
helps speed up the development and review process for new drugs for
conditions for which there is unmet medical need. In their press
release, Q32 Bio quoted Jodie Morrison, the company’s Chief Executive
Officer: “The Fast Track designation granted by the FDA recognizes the
seriousness of AA and the significant current unmet medical need while
underscoring bempikibart's potential as a novel, differentiated
therapy for patients needing new options.”
Bempikibart (ADX-914) is monoclonal antibody that blocks IL-7 and TSLP
signaling in the immune system. In March 2025, NAAF Board Member Dr.
Brett King presented early results from the SIGNAL-AA Phase 2A
clinical trial of bempikibart at the American Academy of Dermatology
meeting in Orlando, Florida. As NAAF previously shared, the findings
were promising, showing significant hair regrowth in patients with
severe and very severe alopecia areata after 24 weeks of treatment.
Notably, when treatment was discontinued, individuals who had
experienced regrowth continued to see further improvement during the
12- to 24-week follow-up period, suggesting the potential for a
long-lasting response even after stopping treatment.
Q32 Bio公司宣布,其治疗斑秃(AA)的研究药物bempikibart已获得快速通道认证,目前正在进行2B期临床试验。 根据美国食品和药物管理局(FDA)的规定,“快速通道 ”有助于加快新药的开发和审查过程,以满足尚未得到满足的医疗需求。Q32 Bio 在新闻稿中援引了公司首席执行官 Jodie Morrison 的话: FDA授予的 “快速通道 ”称号承认了AA的严重性和目前尚未满足的巨大医疗需求,同时强调了bempikibart作为一种新型、差异化疗法的潜力,患者需要新的选择。
Bempikibart(ADX-914)是一种阻断免疫系统中IL-7和TSLP信号传导的单克隆抗体。2025 年 3 月,NAAF 董事会成员 Brett King 博士在佛罗里达州奥兰多举行的美国皮肤病学会会议上介绍了 bempikibart 的 SIGNAL-AA 2A 期临床试验的早期结果。
正如 NAAF 此前所分享的那样,研究结果很有希望,显示重度和极重度斑秃患者在接受 24 周治疗后毛发明显再生。值得注意的是,当停止治疗后,在12至24周的随访期间,毛发再生者的病情继续得到进一步改善,这表明即使在停止治疗后,患者的病情仍有可能得到持久控制。
通过DeepL.com(免费版)翻译