Lipella announces receipt of FDA Type-C meeting guidance on LP-10

Lipella Pharmaceuticals announced the receipt of U.S. Food & Drug Administration, FDA, Type-C meeting guidance regarding the LP-10 clinical program. Lipella expects to initiate a Phase 2b clinical trial evaluating LP-10 as a treatment for hemorrhagic cystitis in approximately 36 patients in the second half of 2024. The FDA provided preliminary agreement on Lipella’s overall trial design, including objectives, safety monitoring, control group monitoring, the dosing protocol, the primary efficacy endpoint, and sample size considerations. Lipella’s Chief Medical Officer, Dr. Michael Chancellor, stated, “We can now proceed with the confidence that our Phase 2b study design can successfully meet its regulatory objectives. This clarity significantly advances our value proposition.”