Jasper Therapeutics' Briquilimab Asthma Trial Approved by Health Canada, Begins Q4 2024
Jasper Therapeutics' Briquilimab Asthma Trial Approved by Health Canada, Begins Q4 2024
Jasper Therapeutics, Inc. (NASDAQ:JSPR) (Jasper), a clinical stage biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) to address mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, today announced that Health Canada has cleared the Company's Clinical Trial Application (CTA) for a Phase 1b/2a asthma challenge study evaluating briquilimab in asthma.
The Phase 1b/2a study in asthma is a single dose double-blind, placebo-controlled study that is expected to enroll 30 patients across as many as 10 sites in Canada and the EU with a key objective of demonstrating proof-of-concept in asthma utilizing a therapeutic dose to inform future trials in the broader asthma population. The study will be conducted utilizing a single 180mg dose of subcutaneous briquilimab and key assessments will be both early and late asthmatic response, changes in airway hyperresponsiveness, mast cell depletion and recovery and safety. Jasper expects to commence dosing patients in the fourth quarter of 2024 and to report initial data in the second half of 2025.
Jasper Therapeutics, Inc. (納斯達克: JSPR) (Jasper)是一家臨床階段的生物技術公司，專注於開發briquilimab，一種新型抗體治療藥物，以靶向c-Kit (CD117)來應對由肥大細胞驅動的疾病，如慢性自發性蕁麻疹 (CSU)，慢性誘發蕁麻疹 (CIndU) 和哮喘。今天宣佈，加拿大衛生部已批准了該公司關於在哮喘患者中評估briquilimab的Ib/2a期哮喘挑戰研究的臨床試驗申請 (CTA)。
哮喘的Ib/2a期研究是一項單劑量雙盲、安慰劑對照的研究，預計將在加拿大和歐盟的10個試驗點招募30名患者，主要目標是利用治療劑量證明哮喘的概念，在廣泛的哮喘人群中指導未來的試驗。該研究將使用一次皮下180mg劑量的briquilimab，關鍵評估將包括早期和晚期的哮喘反應，氣道過度敏感性的變化，肥大細胞的減少和恢復以及安全性。Jasper預計將於2024年第四季度開始給患者用藥，並於2025年下半年報告初步數據。
