Alebund Pharmaceuticals Cleared to Begin Human Trials for IgAN Drug
Shanghai-based Alebund Pharmaceuticals has received U.S. Food and Drug Administration clearance for its investigational new drug, AP308. The approval allows the company to transition its engineered recombinant IgA protease from preclinical research into clinical development, targeting a functional cure for IgA nephropathy.

AP308 represents a distinct approach to treating IgA nephropathy, a condition that affects approximately 9.5 million people globally. Unlike therapies that focus on suppressing IgA production or managing downstream inflammation, this drug acts as an engineered protease derived from human commensal bacteria. It is designed to directly cleave and clear pathogenic IgA and complement C3 deposits that have already accumulated in the glomeruli.
The development of AP308 stems from a 2022 partnership with Peking University First Hospital, utilizing Alebund’s proprietary Long-Acting Protease Engineering Platform. Preclinical results published in the journal Kidney International indicate that the drug can clear pre-existing glomerular deposits within seven days. In humanized mouse models, once-weekly subcutaneous dosing reduced circulating IgA immune complexes by roughly 80% without impacting other vital immunoglobulins. Alebund intends to launch clinical trials in the near term to evaluate the safety and efficacy of this approach in patients.
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