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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 宣佈 FDA 批准其科創板-0310 的 IND 申請,這是一種針對過敏性皮膚炎的單克隆抗體 OX40 拮抗劑。
Benzinga ·  12/10 21:06

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

-- STAR-0310在健康志願者中的1a期試驗預計於2025年第一季度啓動 --

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

-- 早期概念驗證結果預計在2025年第三季度公佈 --

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. (納斯達克:ATXS)是一家專注於開發改變生活的過敏和免疫疾病治療方案的生物製藥公司,今天宣佈美國食品藥品監督管理局(FDA)已批准其STAR-0310單克隆抗體OX40拮抗劑的研究性新藥(IND)申請,該公司正在開發其作爲特應性皮炎(AD)及其他潛在適應症的治療方法。STAR-0310在健康受試者中的1a期試驗預計於2025年第一季度啓動,早期概念驗證結果預計在2025年第三季度公佈。此外,該公司預計在2026年第二季度獲得特應性皮炎患者的概念驗證結果。

譯文內容由第三人軟體翻譯。


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