BEACON: Positive Results Announced for Briquilimab in Chronic Spontaneous Urticaria

Briquilimab therapy may lead to rapid and sustained disease control in patients with chronic spontaneous urticaria (CSU), new data suggest, with the majority of users achieving complete symptom resolution within weeks.1

These data were announced by Jasper Therapeutics, Inc., highlighting the effects of patients with CSU given briquilimab, an investigational monoclonal antibody designed to target KIT (CD117). CSU itself is associated with various negative comorbidities and is known to impact approximately 1% of the general population around the world, including approximately 3 million people in the US.2

“We are very pleased to present data from additional patients enrolled in the BEACON study, which reaffirms the potential of briquilimab to drive rapid and durable disease control in patients with CSU,” Daniel Adelman, MD, the acting Chief Medical Officer of Jasper, said in a statement.1 “We are also pleased by the performance of the 180mg Q8W dose in the open label extension study, with the strong efficacy observed in CSU and CIndU patients.”

In their announcement, Jasper highlighted these encouraging updated clinical findings from the phase 1b/2a BEACON study in adults with CSU. They also released findings from an ongoing open-label extension involving patients with CSU and chronic inducible urticaria (CIndU). Briquilimab is being currently assessed for mast cell–mediated conditions such as asthma, CSU, and CIndU.

The BEACON analysis was designed as a randomized, double-blind, placebo-controlled phase 1b/2a trial evaluating escalating doses of briquilimab administered subcutaneously in adults with moderate-to-severe CSU. These patients had been symptomatic despite the use of high-dose antihistamine therapy.

In their main objectives, BEACON investigators focused on safety and tolerability. Secondary outcomes involved assessment of clinical activity and pharmacokinetic and pharmacodynamic impacts on patients with CSU. Clinical efficacy was mainly determined via the Urticaria Activity Score over 7 days (UAS7). This combines the Hives Severity Score and daily Itch Severity Score on a scale ranging from 0 - 42.

The updated dataset incorporates 8 newly involved participants in the 240 mg/180 mg every-8-weeks patient group, 2 of whom were placed into the placebo arm. The mean reduction, among patients given briquilimab (n=6), in UAS7 from the point of baseline reached 31.0 points at the 12-week mark. A rapid level of symptom resolution was noted by the BEACON investigators, with 83% of those treated attaining a complete response by Week 3.

At the 12-week mark, complete responses were shown to be maintained by 67% of briquilimab-treated study subjects. Additionally, across the BEACON study, briquilimab continued to demonstrate a strong safety profile. The investigative team highlighted a lack of any dose-limiting toxicities and the uncommon observation of adverse events associated with KIT inhibition. AEs did appear were generally mild in severity, and did not lead to treatment discontinuation or delays in use. Most of these AEs resolved with continued dosing.

In the open-label extension study of BEACON, individuals with CSU who completed BEACON and individuals with CIndU who completed follow-up in the SPOTLIGHT study, were included. All of those assessed were treated with briquilimab 180 mg every 8 weeks. Efficacy outcomes from 36 patients with CSU and 17 with CIndU were reported after they completed at least 12 weeks of follow-up.

By this 12-week mark, 58% of participants with CSU attained a complete response. 75% attained either complete response or well-controlled disease, the latter being defined as UAS7 scores of 6 or under. Among those in the CIndU cohort, 65% of individuals evaluated attained either a complete or partial response at the 16-week mark, corresponding to 8 weeks following the second dose.

“Taken together with the favorable safety and tolerability profile observed in both studies, we believe these data are sufficient to support a differentiated profile for briquilimab in chronic urticaria,” Adelman said in a statement.1

References

1. Jasper Therapeutics Reports Positive Updated Data from Briquilimab Studies in Chronic Spontaneous Urticaria. Jasper Therapeutics. January 8, 2025. https://www.globenewswire.com/news-release/2026/01/08/3215192/0/en/Jasper-Therapeutics-Reports-Positive-Updated-Data-from-Briquilimab-Studies-in-Chronic-Spontaneous-Urticaria.html.

2. Kolkhir P, Bonnekoh H, Maurer M, et al. Chronic Spontaneous Urticaria: A Review. JAMA. 2024 Nov 5;332(17):1464-1477. doi: 10.1001/jama.2024.15568. PMID: 39325444.