Lipella Pharmaceuticals announces FDA clearance of IND for LP-410

Lipella Pharmaceuticals announces that the U.S. Food and Drug Administration, FDA, has approved an Investigational New Drug, IND, application for clinical testing of LP-410 in the treatment of oral Graft-Versus-Host Disease, GVHD. Lipella’s clinical study, titled, A Multicenter, Dose-Ranging Trial Evaluating the Safety, Tolerability, and Efficacy of LP-410 in Subjects with Symptomatic Oral GVHD, is expected to commence in the second half of 2024. Dr. Jonathan Kaufman, CEO of Lipella, said, “We are extremely pleased to announce the approval of our IND application, and we look forward to initiating clinical testing in patients in 2024. This is an important milestone for Lipella as we pursue a potential treatment for this patient population.”