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Astria Therapeutics Announces FDA Clearance Of IND Application For STAR-0310, A Monoclonal Antibody OX40 Antagonist For The Treatment Of Atopic Dermatitis

Astria Therapeutics Announces FDA Clearance Of IND Application For STAR-0310, A Monoclonal Antibody OX40 Antagonist For The Treatment Of Atopic Dermatitis

Astria Therapeutics 宣布 FDA 批准其科创板-0310 的 IND 申请,这是一种针对过敏性皮肤炎的单克隆抗体 OX40 拮抗剂。
Benzinga ·  12/10 21:06

-- Phase 1a Trial of STAR-0310 in Healthy Volunteers Expected to Initiate in Q1 2025 --

-- STAR-0310在健康志愿者中的1a期试验预计于2025年第一季度启动 --

-- Early Proof-of-Concept Results Expected in Q3 2025 --

-- 早期概念验证结果预计在2025年第三季度公布 --

Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced the U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for STAR-0310, a monoclonal antibody OX40 antagonist, the company is developing as a potential treatment for atopic dermatitis (AD) and potentially other indications. A Phase 1a trial of STAR-0310 in healthy subjects is expected to initiate in the first quarter of 2025, with early proof-of-concept results expected in the third quarter of 2025. Further, the company anticipates proof-of-concept results in atopic dermatitis patients in the second quarter of 2026.

Astria Therapeutics, Inc. (纳斯达克:ATXS)是一家专注于开发改变生活的过敏和免疫疾病治疗方案的生物制药公司,今天宣布美国食品药品监督管理局(FDA)已批准其STAR-0310单克隆抗体OX40拮抗剂的研究性新药(IND)申请,该公司正在开发其作为特应性皮炎(AD)及其他潜在适应症的治疗方法。STAR-0310在健康受试者中的1a期试验预计于2025年第一季度启动,早期概念验证结果预计在2025年第三季度公布。此外,该公司预计在2026年第二季度获得特应性皮炎患者的概念验证结果。

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