Jasper Therapeutics has reported updated data from its BEACON Phase 1b/2a study of briquilimab, a subcutaneous antibody therapy for chronic spontaneous urticaria (CSU). Single doses of 240mg and 360mg of briquilimab showed high efficacy, with 89% of participants achieving a complete response. However, results from the multiple-dose cohorts (240mg every eight weeks and 240mg followed by 180mg every eight weeks) were compromised by issues with a specific drug product lot.
These findings are crucial for the CSU treatment landscape. Positive results from the single-dose cohorts reinforce the potential of briquilimab to address unmet needs for CSU patients who don’t respond adequately to current therapies. Confirming the efficacy and safety of briquilimab could lead to a new, effective treatment option and expand Jasper’s market reach. The drug lot issue, however, highlights the importance of stringent quality control in drug development and manufacturing, impacting both the BEACON study timeline and potentially eroding investor confidence.
The single-dose cohorts (240mg and 360mg) demonstrated rapid disease control, with 78% of participants achieving a clinical response by week 2. In the open-label extension study, 73% of participants receiving 180mg every eight weeks achieved a complete response at 12 weeks. Unfortunately, a problematic drug lot impacted 10 of 13 patients in the multi-dose cohorts. Jasper is investigating this issue and expects results in the coming weeks. Meanwhile, they are providing new drug product to affected patients and plan to enroll 10-12 additional participants in the multi-dose cohorts. Due to the use of the affected drug lot in the ETESIAN asthma trial, Jasper is halting that study and pausing development in asthma and SCID, implementing cost-cutting measures to extend their financial runway.
The delay caused by the drug product lot issue is a setback for briquilimab’s development. However, the strong results in the single-dose and open-label extension cohorts suggest that briquilimab still holds considerable promise for CSU treatment. The next steps involve a thorough investigation of the drug lot, generation of robust data from additional multi-dose cohort participants, and successful implementation of cost-cutting measures. These actions will determine briquilimab’s path forward and Jasper’s ability to deliver a potentially game-changing therapy to CSU patients.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
