Singapore, Sept. 9 -- Alebund Pharmaceuticals has received clearance from the US Food and Drug Administration for the Investigational New Drug application of AP308, a first-in-class engineered recombinant IgA protease being developed for IgA nephropathy.

The clearance moves AP308 from preclinical research into clinical development, with Alebund planning to initiate the study in the near term.

AP308 is designed to directly cleave and clear pathogenic IgA and IgA immune complexes associated with IgA nephropathy.

The therapy is based on an IgA protease derived from Thomasclavelia ramosa, a human commensal bacterium.

According to Alebund, the engineered protease can cleave IgA1, galactose-deficient IgA1, polymeric IgA and IgA immune compl...