Jasper Therapeutics, Inc. has announced the dosing of the first patient in its Phase 1b/2a clinical study, named ETESIAN, evaluating briquilimab in patients with allergic asthma. This study marks a significant step in exploring a novel approach to treating asthma by targeting mast cell activity. The ETESIAN study (Evaluating The Efficacy and Safety of briquilimab In participANts with allergic asthma) is designed as a double-blind, placebo-controlled challenge study, and will assess the impact of a single 180mg subcutaneous dose of briquilimab.
The Phase 1b/2a trial aims to enroll approximately 30 patients across multiple sites in Canada. Key objectives include demonstrating proof-of-concept for briquilimab in asthma, utilizing a potential therapeutic dose to inform future trials in a broader asthma population. Assessments will focus on early and late asthmatic responses, changes in airway hyperresponsiveness, mast cell depletion and recovery, and overall safety.
Novel Mechanism of Action
Briquilimab is a targeted aglycosylated monoclonal antibody that inhibits the c-Kit receptor, also known as CD117. By blocking stem cell factor from binding to c-Kit, briquilimab disrupts a critical survival signal, leading to the depletion of mast cells via apoptosis. Mast cells are key drivers of inflammation in diseases like chronic urticaria and allergic asthma, making their depletion a potential therapeutic strategy.
Expert Commentary
Paul O’Byrne, M.D., Professor, Dean and Vice President of the Faculty of Health Sciences at McMaster University, commented on the potential of briquilimab: “Depletion of mast cells via inhibition of c-Kit is a novel mechanism with the potential to alleviate asthmatic response in patients underserved by existing therapies. As a potent and targeted c-Kit inhibitor, I believe briquilimab has the potential to overcome the safety issues that have limited development of other c-Kit inhibiting agents and, in turn, serve as an important treatment option for patients suffering from asthma. I look forward to enrolling patients into the ETESIAN study.”
Briquilimab's Development
Briquilimab has demonstrated a favorable safety profile in over 160 participants and healthy volunteers across various clinical studies. These studies have explored its use in conditions such as chronic inducible urticaria (CIndU) and as a conditioning agent in severe combined immunodeficiency (SCID), acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), Fanconi anemia (FA), and sickle cell disease (SCD).
Anticipated Timeline
Jasper Therapeutics anticipates reporting initial data from the ETESIAN study in the second half of 2025. These results will provide crucial insights into the efficacy and safety of briquilimab as a potential treatment for allergic asthma.