ALEBUND-B(09637): The clinical trial application for AP308, a new drug for the treatment of IgA nephropathy, has been approved by the U.S. Food and Drug Administration.

ALEBUND-B (09637) announced that the company has recently received approval from the U.S. Food and Drug Administration (FDA) for the clinical trial application (IND) of AP308, a pioneering engineered recombinant IgA protease of its kind. This will initiate the first human clinical trial of AP308 for the treatment of IgA nephropathy (IgAN). To the company's knowledge, AP308 is the first IgA protease candidate for IgAN to receive approval for clinical trials. The company plans to start this clinical trial soon. AP308 is designed to achieve a functional cure for IgA nephropathy and is the first engineered recombinant IgA protease of its kind. The drug is based on an IgA protease derived from the human commensal bacterium Thomasclavelia ramosa, which can cleave IgA1, galactose-deficient IgA1 (Gd-IgA1), polymeric IgA, and IgA immune complexes. It can also directly clear IgA immune complexes and complement C3 deposits in the glomeruli; in preclinical studies, it acts within minutes and does not affect other immunoglobulins such as IgG and IgM. In January 2022, Libang Pharmaceutical entered into a collaboration with Peking University First Hospital (PKU Hospital) to develop the IgA protease as a potential therapy for IgAN and established a licensing agreement with PKU Hospital. The company subsequently developed and confirmed AP308 as a candidate drug based on its independently developed long-acting protease engineering platform. This platform has excellent stability and drug-like properties, allowing for a significant extension of the drug's in vivo half-life, reduced renal clearance, and diminished immunogenicity while retaining the proteases high efficacy in cleaving IgA1, laying the foundation for long-acting and infrequent dosing. The company holds the global rights for the development, production, and commercialization of AP308.