Jade Biosciences (JBIO) Study update summary

Key study results and objectives

• JADE101 phase I trial in healthy volunteers showed rapid, deep, and durable IgA reductions of ~70% at 12 weeks after a 700 mg dose, outperforming first-generation anti-APRILs and supporting a 12-week maintenance dosing interval.

• Achieved ultra-high binding affinity, extended half-life (24.2 days), and efficient target engagement, enabling infrequent dosing and best-in-class IgA lowering potency.

• No serious or severe adverse events, deaths, or discontinuations; all adverse events were mild or moderate, with no hypogammaglobulinemia or significant immunogenicity impact.

• Pharmacodynamic modeling predicts best-in-class IgA reductions and rapid onset, supporting a Q12-week dosing regimen for IgAN patients.

• IgA-lowering potency was 379-fold higher than sibeprenlimab and 26-fold higher than povetacicept.

Study design and methodology

• First-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in 32 healthy adults, with four cohorts (175, 350, 700, 1400 mg) and follow-up up to 8 months.

• Primary objective: safety and tolerability; secondary/exploratory: pharmacokinetics, pharmacodynamics, immunogenicity, and IgA reduction.

• High concentration formulation allows 350 mg to be delivered in a single injection, compatible with prefilled syringe or auto-injector.

• Baseline characteristics were balanced and representative, supporting generalizability.

Safety and pharmacokinetics

• No severe adverse events, deaths, or discontinuations; all treatment-emergent adverse events were mild or moderate.

• No clinically significant changes in ECGs, vitals, or safety labs; no cases of hypogammaglobulinemia or IgG ≤3 g/L.

• Most common adverse events were headache, upper respiratory tract infection, injection site erythema, oropharyngeal pain, and pyrexia.

• No apparent impact of anti-drug antibodies on pharmacokinetics or pharmacodynamics.

• JADE101 showed dose-dependent increases in exposure and a half-life at steady state 8.7-fold longer than povetacicept and 2.6-fold longer than sibeprenlimab.