ALEBUND-B (09637) has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for AP308, a first-in-class engineered recombinant IgA protease. This clearance paves the way for the company to launch a first-in-human clinical trial of AP308 in patients with IgA nephropathy (IgAN).

To the company's knowledge, AP308 stands as the first IgA protease-based candidate for IgAN to receive approval for clinical investigation. The company plans to commence the trial shortly.

AP308 is a first-in-class engineered recombinant IgA protease designed to achieve functional cure for IgA nephropathy. Developed based on an IgA protease derived from the human commensal bacterium Thomasclavelia ramosa, the drug can cleave IgA1, galactose-deficient IgA1 (Gd-IgA1), polymeric IgA, and IgA immune complexes. It also directly clears IgA immune complex and complement C3 deposits in the glomerulus, with preclinical studies showing activity within minutes while sparing other immunoglobulins like IgG and IgM.

In January 2022, ALEBUND-B entered a collaboration with Peking University First Hospital (PKUFH) to develop IgA protease as a potential therapy for IgAN and signed a licensing agreement with the hospital. Building on this partnership, the company leveraged its proprietary long-acting protease engineering platform to identify and advance AP308 as a candidate. The platform delivers excellent stability and drugability, extending the drug's in vivo half-life, reducing renal clearance, and attenuating immunogenicity while preserving the protease's high-efficiency cleavage activity against IgA1, laying the groundwork for long-acting, low-frequency dosing. The company holds global development, manufacturing, and commercialization rights to AP308.