Jasper Therapeutics Receives FDA Clearance for Clinical Study of Briquilimab in Chronic Urticaria

Jasper Therapeutics, a biotechnology company focused on developing briquilimab, a novel antibody therapy, has announced that its investigational new drug (IND) application for a Phase 1b/2a clinical study has been cleared by the U.S. Food and Drug Administration (FDA). The study aims to evaluate the efficacy of subcutaneous briquilimab in the treatment of chronic spontaneous urticaria (CSU), a mast cell-driven disease.

The Phase 1b/2a study will involve adult CSU patients who have not responded to or cannot tolerate omalizumab, a current treatment option. Approximately 40 patients will be enrolled across six cohorts, and the primary focus will be on assessing the safety and tolerability of briquilimab. Secondary endpoints will include efficacy measures and pharmacokinetics.

Jasper Therapeutics is optimistic that this dose escalation study will provide proof of concept for the depletion of mast cells by briquilimab, showcasing its differentiated mechanism of action in CSU. The study is expected to commence in early 2024, with the first patient anticipated to be dosed by the end of 2023. Early data from the study’s cohorts is projected to be available by mid-2024.

In addition to the CSU study, Jasper Therapeutics is also planning a proof of concept study in chronic inducible urticaria (CIndU) to further expand its mast cell franchise. The company has filed a clinical trial application for the CIndU study with the European Medicines Agency and expects to commence the study in the first quarter of 2024, with initial data expected by year-end 2024.

Ronald Martell, President and CEO of Jasper Therapeutics, expressed the significance of the IND clearance for the CSU study, highlighting it as a critical milestone for the company’s pipeline expansion. He also emphasized the potential of briquilimab in addressing mast cell diseases.

Jasper Therapeutics is a clinical-stage biotechnology company dedicated to developing briquilimab as a targeted treatment for chronic mast and stem cell diseases. The antibody therapy has shown promising efficacy and safety profiles in previous studies, demonstrating its potential as a primary treatment for chronic urticaria and as a conditioning agent for stem cell transplants in rare diseases.

For more information about Jasper Therapeutics and its ongoing research, please visit www.jaspertherapeutics.com.