Lipella Reveals Receipt Of FDA Type-C Meeting Guidance Regarding LP-10 (Liposomal Tacrolimus) Clinical Program; Plans To Advance Lead Product Candidate To Phase 2b
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.
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."