Jasper Therapeutics(US:JSPR)2025-12-02 13:00BEACON Trial Investigation Results - Internal investigation indicates anomalous efficacy results in the BEACON trial are likely due to patient-specific factors rather than issues with the drug product or study conduct[23] - A KOL panel review suggested that 9 out of 10 patients who did not respond in the US may not have had CSU, highlighting potential misdiagnosis issues common in CSU studies where 25%-30% of patients are incorrectly diagnosed[40] - Redosing Cohort 8 & 9 patients with a different drug product lot did not significantly change efficacy outcomes, with no incremental efficacy observed in 8 of 9 patients redosed[27, 31] - In the BEACON trial, 7 of 10 US patients in Cohorts 8 & 9 were switched to a different drug product lot by week 16[27, 31] ETESIAN Trial Interim Results - A single 180mg dose of Briquilimab in the ETESIAN study demonstrated a reduction in serum tryptase levels at 6 weeks, consistent with previous observations[45] - Briquilimab mitigated the effects of allergen challenge on FEV1 response, showing a sustained impact on asthmatic response at 6 and 12 weeks[47] - Briquilimab dramatically reduced airway hyper-responsiveness, increasing the concentration of methacholine needed to drive a 20% drop in FEV1 (PD20)[51] - Sputum eosinophil response was suppressed by Briquilimab at both 6-week and 12-week allergen challenge timepoints[53] Program Status and Next Steps - In CSU, single doses of 240mg and 360mg of Briquilimab led to more than a 24-point drop in UAS7, with 82% CR and 91% WC disease by week 4 (n=11)[60] - In an OLE study for CSU, 180mg Q8W of Briquilimab resulted in 73% CR and 82% WC disease at 12 weeks (n=11)[60]