Jasper Therapeutics Announces First Patient Dosed In Phase 1b/2a SPOTLIGHT Clinical Study Of Briquilimab In Chronic Inducible Urticaria
Jasper Therapeutics Announces First Patient Dosed In Phase 1b/2a SPOTLIGHT Clinical Study Of Briquilimab In Chronic Inducible Urticaria
Jasper Therapeutics, Inc. (NASDAQ:JSPR) (Jasper), a biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) in mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), today announced that the first patient has been dosed in Jasper's Phase 1b/2a (SPOTLIGHT) clinical study of subcutaneous briquilimab for the treatment of CIndU. The SPOTLIGHT study is evaluating a single administration, at two different dose levels, of subcutaneous briquilimab in adult patients with cold urticaria (ColdU) or symptomatic dermographism (SD).
专注于开发briquilimab的生物技术公司Jasper Therapeutics, Inc.（纳斯达克股票代码：JSPR）（Jasper）今天宣布，已在贾斯珀的1b/2a期（SPOTLIGHT）（SPOTLIGHT）的1b/2a期（SPOTLIGHT）等肥大细胞驱动的疾病中给药了第一位患者。皮下用布里曲利单抗治疗CindU的临床研究。CD117SPOTLIGHT研究正在评估在感冒性荨麻疹（ColDU）或有症状的皮肤造影术（SD）的成年患者中，在两种不同的剂量水平下单次使用briquilimab。
"We are excited to announce dosing of the first patient in the SPOTLIGHT study in patients with CIndU, our second clinical program evaluating briquilimab in a mast cell-mediated disease," said Edwin Tucker, Chief Medical Officer of Jasper. "As with our BEACON study in CSU, we expect the SPOTLIGHT study to establish proof of concept for the depletion of mast cells by briquilimab in CIndU and help us to determine doses and dosing regimens for future registrational studies. We plan to provide enrollment updates as we progress through the study and anticipate reporting preliminary data in the second half of 2024."
贾斯珀首席医学官埃德温·塔克说：“我们很高兴地宣布，SPOTLIGHT研究中的第一位患者在CindU患者中给药，这是我们第二个评估briquilimab治疗肥大细胞介导疾病的临床项目。”“与我们在科罗拉多州立大学的BEACON研究一样，我们预计SPOTLIGHT研究将为briquilimab在CindU中消耗肥大细胞提供概念验证，并帮助我们为未来的注册研究确定剂量和给药方案。随着研究的进展，我们计划提供最新入学情况，并预计将在2024年下半年报告初步数据。”
The SPOTLIGHT study is expected to enroll approximately 15 patients across 2 dose cohorts. The primary endpoints are safety and tolerability of briquilimab with secondary endpoints focused on efficacy measures and pharmacokinetics. The study is being conducted at four sites in the EU. Jasper anticipates reporting preliminary data from the SPOTLIGHT study in the second half of 2024.
SPOTLIGHT研究预计将在2个剂量队列中招收约15名患者。主要终点是briquilimab的安全性和耐受性，次要终点侧重于疗效指标和药代动力学。该研究正在欧盟的四个地点进行。贾斯珀预计将在2024年下半年报告SPOTLIGHT研究的初步数据。
"c-Kit inhibitors are a promising class of monoclonal therapeutics with demonstrated efficacy in mast cell driven diseases," said Marcus Maurer, M.D., Professor of Dermatology and Allergy at Charité – Universitätsmedizin in Berlin. "As a potent and differentiated c-Kit inhibitor, I believe briquilimab has the potential to serve as an important treatment option for patients suffering from CIndU, and I look forward to enrolling patients into the SPOTLIGHT study and additionally into the BEACON study for CSU."
柏林查里特大学皮肤病学和过敏学教授马库斯·毛雷尔医学博士说：“C-kit抑制剂是一类前景看好的单克隆疗法，在肥大细胞驱动的疾病中已显示出疗效。”“作为一种有效的差异化C-kit抑制剂，我相信briquilimab有可能成为CindU患者的重要治疗选择，我期待着让患者参与SPOTLIGHT研究以及科罗拉多州立大学的BEACON研究。”