Jade Biosciences has reported positive interim data from its Phase I trial studying JADE101, an investigational anti-A proliferation-inducing ligand (APRIL) monoclonal antibody for immunoglobulin A nephropathy (IgAN).
The placebo-controlled, double-blind trial evaluated the tolerability, safety, pharmacokinetics, and pharmacodynamics of single-ascending subcutaneous doses of JADE101 in 32 healthy volunteers.
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Doses tested were 175mg, 350mg, 700mg, and 1,400mg.
Key findings show mean IgA reductions of around 70% from baseline, sustained at 12 weeks at the 700mg dose.
JADE101’s potency resulted in faster, more durable IgA-lowering compared to first-generation anti- APRIL or dual APRIL/B-cell activating factor (BAFF) inhibitors.
Simulations indicate greater than 70% IgA reductions with 350mg every 12 weeks after a 700mg induction dose.
JADE101 was well tolerated across all dose levels, with the most common adverse events being headache, upper respiratory tract infection, injection site erythema, oropharyngeal pain, and pyrexia.
No serious adverse events, study discontinuations or hypogammaglobulinaemia cases were observed.
Pharmacokinetic analysis demonstrated an extended half-life and lower target-mediated drug disposition threshold compared to existing therapies. No impact from anti-drug antibodies on pharmacokinetics or pharmacodynamics was detected.
Jade Biosciences CEO Tom Frohlich said: “The interim results from this Phase I trial showed that JADE101 drove rapid, deep and durable IgA reductions in healthy volunteers, with favourable tolerability and the potential for dosing every 12 weeks.
“These data position JADE101 as a potentially best-in-class anti-APRIL therapy at the forefront in a large and growing market.”
The ongoing JUNIPER Phase II trial is enrolling around 30 participants with IgAN, receiving an initial 700mg dose followed by 350mg maintenance doses every eight or 12 weeks.
Interim data are expected in 2027. A Phase III trial is planned for the first half of 2027.
