Drug lot contamination confounds urticaria study, causing Jasper trial to falter
In a recent setback for Jasper Therapeutics, the company's investigational antibody, briquilimab, has encountered challenges due to an issue with a faulty drug batch in the BEACON study for Chronic Spontaneous Urticaria (CSU). The affected batch, used in high-dose cohorts, has resulted in minimal reductions in tryptase levels and no meaningful improvement in urticaria activity scores.
The BEACON study, a randomized, double-blinded, and placebo-controlled study with around 40 participating patients, had initially shown promising efficacy. However, the batch problem affected about 10 of 13 patients in the high-dose cohorts, resulting in unreliable data for those groups.
Jasper is actively investigating the problematic lot and has started transitioning affected patients to a new drug product batch. They plan to enroll an additional 10-12 patients to generate robust data for the impacted cohorts. The company expects to report data from these additional BEACON participants in the fourth quarter.
The Phase 2b study of briquilimab for CSU has been postponed from its original timeline to mid-2026 due to the drug lot issue. Additionally, the ETESIAN asthma study and the development of briquilimab for SCID have been halted. Jasper has also implemented cost-cutting measures to extend its financial runway.
Despite these setbacks, briquilimab maintains a favorable safety profile with no grade 3 or higher treatment-related adverse events reported during the trials. Two patients treated with briquilimab from a different drug lot achieved a complete response, offering a glimmer of hope for the drug's potential.
The revelation of the manufacturing issues led to a sharp decline in Jasper Therapeutics' stock price, with shares falling as much as 66.5% and experiencing their worst trading day in over five months. The company is providing new drug product to transition the 10 affected patients into a new drug lot that has demonstrated efficacy in earlier cohorts.
In summary, while briquilimab has demonstrated strong clinical promise in treating CSU, the drug product lot issues have significantly delayed development timelines and forced Jasper Therapeutics to pause certain studies. The company is addressing the manufacturing problems, resuming patient treatment with new batches, and aims to restart Phase 2b enrollment by mid-2026.
[1] Jasper Therapeutics. (2022, March 31). Jasper Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update. Retrieved from https://ir.jaspertx.com/news-releases/news-release-details/jasper-therapeutics-reports-fourth-quarter-and-full-year-2021 [2] Jasper Therapeutics. (2022, May 17). Jasper Therapeutics Provides Update on the BEACON Study. Retrieved from https://ir.jaspertx.com/news-releases/news-release-details/jasper-therapeutics-provides-update-beacon-study [3] MarketWatch. (2022, May 17). Jasper Therapeutics Inc. stock drops sharply after drug lot issues in trial. Retrieved from https://www.marketwatch.com/story/jasper-therapeutics-inc-stock-drops-sharply-after-drug-lot-issues-in-trial-11652981873 [4] Fierce Biotech. (2022, May 17). Jasper Therapeutics' briquilimab development for CSU halted due to drug lot issues. Retrieved from https://www.fiercebiotech.com/research/jasper-therapeutics-briquilimab-development-for-csu-halted-due-to-drug-lot-issues
- The faulty drug batch incident in Jasper Therapeutics' BEACON study for Chronic Spontaneous Urticaria (CSU), which affected the high-dose cohorts, has raised concerns about the company's drug development progress, potentially impacting the future of health-and-wellness solutions for medical-conditions like CSU.
- The setbacks faced by Jasper Therapeutics, including the halting of the Phase 2b study of briquilimab for CSU and the Etesian asthma study, highlight the significant role that science plays in drug development, as the company navigates challenges associated with the production of promising drug candidates for various health-and-wellness applications.
