– OpSCF is a novel monoclonal antibody directed against the inflammatory form of stem cell factor

-OpSCF是一种针对干细胞因子炎症形式的新型单克隆抗体

BRYN MAWR, Pa., Nov. 29, 2023 /PRNewswire/ -- Opsidio, LLC, a clinical stage biotechnology company dedicated to advancing innovative therapies for inflammatory diseases, today announced the dosing of the first patient in the Phase 2a clinical trial of OpSCF, Opsidio's pioneering monoclonal antibody against stem cell factor, in patients suffering from moderate to severe atopic dermatitis.

BRYN MAWR，Pa，2023年11月29日/PRNewswire/-Opsidio，LLC，一家致力于推进炎症性疾病创新疗法的临床阶段生物技术公司，今天宣布在2a期临床试验中给予第一名患者OpSCF，Opsidio开创性的抗干细胞因子单克隆抗体，用于患有中度至重度特应性皮炎的患者。

Opsidio is collaborating with AbbVie for the development of OpSCF..

Opsidio正在与AbbVie合作开发OpSCF。。

'Opsidio is excited to announce the commencement of our Phase 2a study for atopic dermatitis, marking a significant step forward in our mission to improve the lives of patients with chronic inflammatory conditions,' said Martin Phillips, MD, CEO of Opsidio.

Opsidio首席执行官马丁·菲利普斯（Martin Phillips）博士说：“Opsidio很高兴宣布开始我们针对特应性皮炎的2a期研究，标志着我们改善慢性炎症患者生活的使命向前迈出了重要一步。

The currently enrolling OpSCF-201 study is a randomized, double-blind, placebo-controlled, Phase 2a study to evaluate the efficacy and safety of OpSCF in treating adults with moderate to severe atopic dermatitis. The primary endpoint is the percent change in the Eczema Area and Severity Index (EASI) score from baseline, at week 16.

目前正在招募的OpSCF-201研究是一项随机，双盲，安慰剂对照的2a期研究，旨在评估OpSCF治疗中重度特应性皮炎成人的疗效和安全性。主要终点是第16周时湿疹面积和严重程度指数（EASI）评分与基线的百分比变化。

Secondary endpoints include safety and tolerability and improvement in pruritus, body surface area, and quality of life. Importantly, OpSCF-201 includes an open label extension period of 40 weeks, ensuring all subjects have an opportunity to receive OpSCF while participating in the study. For more information regarding this study, please visit https://www.clinicaltrials.gov/study/NCT06101823.

次要终点包括安全性和耐受性以及瘙痒，体表面积和生活质量的改善。重要的是，OpSCF-201包括40周的开放标签延长期，确保所有受试者在参与研究时都有机会接受OpSCF。有关此研究的更多信息，请访问https://www.clinicaltrials.gov/study/nct06101823.

Previously, OpSCF was evaluated in a 115-subject phase 1a/b study and was found to be safe and well tolerated, following single or multiple ascending dose administration in healthy volunteers.

以前，OpSCF在115名受试者的1a/b期研究中进行了评估，并且在健康志愿者中单次或多次递增剂量给药后发现其安全且耐受性良好。

About OpSCFOpSCF is a monoclonal antibody that targets stem cell factor which plays a crucial role in the inflammatory pathway that leads to atopic dermatitis. By targeting a specific isoform of stem cell factor (SCF248) that drives inflammation, we hope to offer patients a more effective and durable treatment option, while avoiding the negative effects of broad stem cell factor inhibition..

关于OpSCFOpSCF是靶向干细胞因子的单克隆抗体，其在导致特应性皮炎的炎症途径中起关键作用。通过靶向驱动炎症的特定干细胞因子（SCF248）同种型，我们希望为患者提供更有效和持久的治疗选择，同时避免广泛干细胞因子抑制的负面影响。。

About Opsidio Opsidio LLC is a clinical-stage biotechnology company developing therapies for the millions of people affected by the damaging effects of chronic inflammation. Chronic inflammation is the hallmark of a number of severe atopic and fibrotic diseases. Please visit www.opsidio.com.

关于Opsidio Opsidio LLC是一家临床阶段生物技术公司，为数百万受慢性炎症破坏影响的人开发治疗方法。慢性炎症是许多严重的特应性和纤维化疾病的标志。请访问www.opsidio.com。

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