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).
專注於開發briquilimab的生物技術公司Jasper Therapeutics, Inc.（納斯達克股票代碼：JSPR）（Jasper）今天宣佈，已在賈斯珀的1b/2a期（SPOTLIGHT）（SPOTLIGHT）的1b/2a期（SPOTLIGHT）等肥大細胞驅動的疾病中給藥了第一位患者。皮下用布里曲利單抗治療CindU的臨床研究。CD117SPOTLIGHT研究正在評估在感冒性蕁麻疹（ColDU）或有症狀的皮膚造影術（SD）的成年患者中，在兩種不同的劑量水平下單次使用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."
賈斯珀首席醫學官埃德溫·塔克說：“我們很高興地宣佈，SPOTLIGHT研究中的第一位患者在CindU患者中給藥，這是我們第二個評估briquilimab治療肥大細胞介導疾病的臨床項目。”“與我們在科羅拉多州立大學的BEACON研究一樣，我們預計SPOTLIGHT研究將爲briquilimab在CindU中消耗肥大細胞提供概念驗證，並幫助我們爲未來的註冊研究確定劑量和給藥方案。隨着研究的進展，我們計劃提供最新入學情況，並預計將在2024年下半年報告初步數據。”
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研究預計將在2個劑量隊列中招收約15名患者。主要終點是briquilimab的安全性和耐受性，次要終點側重於療效指標和藥代動力學。該研究正在歐盟的四個地點進行。賈斯珀預計將在2024年下半年報告SPOTLIGHT研究的初步數據。
"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."
柏林查裏特大學皮膚病學和過敏學教授馬庫斯·毛雷爾醫學博士說：“C-kit抑制劑是一類前景看好的單克隆療法，在肥大細胞驅動的疾病中已顯示出療效。”“作爲一種有效的差異化C-kit抑制劑，我相信briquilimab有可能成爲CindU患者的重要治療選擇，我期待着讓患者參與SPOTLIGHT研究以及科羅拉多州立大學的BEACON研究。”