Jasper Therapeutics Reports Significant Findings from SPOTLIGHT Study
11 of 12 participants (92%) in the 180mg cohort saw complete response.
All 12 participants (100%) in the cohort achieved clinical responses.
Tryptase levels fell below quantitative limits in 10 of 12 participants (83%).
No serious adverse events or grades 3+ adverse events in the 180mg cohort.
The company plans to host a conference call and webinar to discuss the study findings.
Jasper Therapeutics, Inc. (Nasdaq: JSPR), a company dedicated to developing briquilimab, an innovative antibody treatment targeting KIT (CD117), shared compelling data from the 180mg cohort of its SPOTLIGHT Phase 1b/2a study. This research focuses on adult patients suffering from chronic inducible urticaria (CIndU). The findings were presented at a prominent annual congress addressing allergens and clinical immunology.
Administering briquilimab subcutaneously in the 180mg dosage has led to impressive control of disease symptoms. Notably, all participants in the cohort experienced clinical responses within an initial eight-week period following treatment. The results exhibited both rapid and sustained effects, where eight out of twelve participants (66%) had favorable clinical outcomes as early as two weeks post-treatment. Furthermore, seven out of twelve (58%) maintained these positive results through week eight.
Ronald Martell, President and Chief Executive Officer of Jasper, expressed his satisfaction with the SPOTLIGHT study outcomes. He highlighted that over 90% of participants reached complete responses, and he emphasized the importance of the drug's tolerability. This finding suggests briquilimab could offer a reliable solution for patients grappling with urticaria symptoms. The results correlate with ongoing studies, showing briquilimab's potential for optimal biological response, and offers hope for a safer treatment profile.
Understanding the SPOTLIGHT Study Design
The SPOTLIGHT study is a detailed Phase 1b/2a trial. It involved a single dose administration of briquilimab in adult patients suffering from cold urticaria (ColdU) or symptomatic dermographism (SD), both of which are frequent types of CIndU refractory to antihistamines. In total, the study encompassed 27 participants, divided into three dosage groups: 40mg, 120mg, and 180mg.
The primary focus of this study is on the safety and tolerability of briquilimab, while secondary aims scrutinize clinical performance alongside pharmacokinetic and pharmacodynamic evaluations, including serum tryptase measurements. Participants demonstrated significant disease challenges based on their baseline provocation testing.
Data Highlights from the 180mg Cohort
In the 180mg cohort, three participants were diagnosed with ColdU, while the remaining nine had SD. Notably, the mean baseline temperature threshold for ColdU patients was 18.7°C, and for SD participants, it was 3.7 of 4. Impressively, every participant in this group responded positively to provocation testing within the analysis period.
A complete response was seen in 11 of 12 participants (92%), wherein participants improved their temperature threshold or FricTest score. Meanwhile, one participant noted a partial response. The earliest observable improvements for some participants emerged within one week of treatment, with rapid enhancement reported at two weeks post-administration.
The overall results are promising, as 22 of the 27 participants (81%) recorded a complete response, while 26 (96%) achieved either complete or partial responses. At the eight-week mark, 58% of individuals continued to show ongoing positive clinical signs.
Safety Profile Observations and Conclusions
Participants in the 180mg cohort exhibited a favorable safety profile throughout the study. Notably, there were no serious adverse events or any graded adverse events of level three or higher reported. Only mild and transient reductions in neutrophil counts affected half of the participants, yet any incidents connected to taste changes were minimal and temporary. The overall positive safety profile of briquilimab remains encouraging.
The results from both the SPOTLIGHT and previous BEACON studies indicate briquilimab's ability to effectively and safely address symptoms in a population often left with limited treatment options. Experts in the field, including Dr. Martin Metz from Charité – Universitätsmedizin Berlin, express enthusiasm for the future of briquilimab as it continues to demonstrate effectiveness in this difficult-to-treat patient group.
Upcoming Conference and Future Directions
On June 16, 2025, Jasper will facilitate a conference call and webinar to further discuss these findings. The session will provide insights into the ongoing developments and potential implications of briquilimab in treating CIndU. Participants interested in engaging with Jasper’s management will have the chance to do so during the Q&A segment following the presentations.
Jasper Therapeutics remains focused on the development of briquilimab as a treatment for chronic mast cell disabilities. This targeted aglycosylated monoclonal antibody is unique in its approach, as it blocks stem cell factor from binding with the KIT receptor, disrupting critical signals and inducing apoptosis in mast cells. As new data retention unfolds, Jasper anticipates progressing alongside patients with chronic urticaria and asthma.
Frequently Asked Questions
What is the SPOTLIGHT study?
The SPOTLIGHT study evaluates briquilimab's safety and efficacy in adults with chronic inducible urticaria.
What were the key findings from the 180mg cohort?
In this group, 92% achieved complete responses, and all participants showed clinical responses.
What safety profile did briquilimab exhibit?
No serious adverse events were reported, and the medication appears to be well tolerated overall.
When will the next conference call take place?
The next conference call and webinar are scheduled for June 16, 2025, at 8:00 a.m. EDT.
What is Jasper Therapeutics focusing on next?
Jasper aims to continue clinical studies for briquilimab as a potential solution for chronic mast cell diseases.
