Lipella Pharmaceuticals summarizes year with strategic progress, key milestones

Lipella Pharmaceuticals celebrates its first anniversary as a publicly traded entity. Based in Pittsburgh, PA, the Company has made substantial strides over the past year, achieving critical milestones and advancing its pipeline with three clinical indications and two orphan drug designations granted. A highlight of the year includes the successful completion of a Type C meeting with the U.S. Food and Drug Administration focused on the clinical program for LP-10, Lipella’s leading drug candidate for the treatment of hemorrhagic cystitis. Jonathan Kaufman, CEO of Lipella, expressed his satisfaction with the meeting’s outcome, noting, “The FDA’s feedback from our recent Type C meeting gives us a clear path forward into 2024. Our planned Phase-2b trial for LP-10 will involve 36 subjects in a double-blind, placebo-controlled study, focusing on the treatment’s impact on gross hematuria.” Further bolstering its portfolio, Lipella has secured FDA approval for its Investigational New Drug application for a Phase 2a multicenter trial of an oral rinse formulation of LP-310, targeting Oral Lichen Planus. With central Institutional Review Board approval in hand, the Company is in the process of selecting study sites for this trial. Additionally, Lipella’s LP-310 has been granted orphan drug designation for the treatment of oral graft-versus-host disease with tacrolimus. The Company is poised to submit a Phase 2a IND for this indication in the first quarter of 2024.