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.
专注于开发briquilimab的临床阶段生物技术公司Jasper Therapeutics, Inc.（纳斯达克股票代码：JSPR）（Jasper）今天宣布，加拿大卫生部已批准该公司的临床试验申请（CTA），用于治疗肥大细胞驱动的疾病，例如慢性自发性荨麻疹（CSU）、慢性诱发性荨麻疹（CINDU）和哮喘。）用于评估briquilimab治疗哮喘的1b/2a期哮喘挑战研究。CD117
哮喘的1b/2a期研究是一项单剂量双盲、安慰剂对照研究，预计将在加拿大和欧盟多达10个地点招收30名患者，其关键目标是利用治疗剂量证明哮喘的概念验证，为未来在更广泛的哮喘人群中进行的试验提供信息。该研究将使用单剂量的180mg皮下briquilimab进行，关键评估将包括早期和晚期的哮喘反应、气道过度反应的变化、肥大细胞消耗以及恢复和安全性。贾斯珀预计将在2024年第四季度开始给患者服药，并在2025年下半年公布初步数据。