Lepu Biopharma-B Wins FDA Approval For First Human Trial Of AP308

Lepu Biopharma-B (09637) said its new drug clinical trial application for AP308 has recently been approved by the U.S. Food and Drug Administration, allowing it to begin a first-in-human clinical trial of AP308 for the treatment of IgA nephropathy. The company said, according to ETNet, AP308 is, to its knowledge, the first IgA protease-based IgA candidate drug approved to enter clinical trials. It plans to start the study soon. Preclinical data showed that after once-weekly subcutaneous dosing for eight weeks in a humanized IgA nephropathy mouse model, AP308 reduced circulating human IgA and IgA immune complex levels by about 80% versus the control group.