Lipella Pharmaceuticals Inc. announces that the U.S. Food and Drug Administration 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. LP-410 targets the underlying mechanisms of oral GVHD, potentially providing a safe and effective treatment option for affected individuals.

Lipella received FDA Orphan Drug Designation on tacrolimus for treatment of GVHD on November 8, 2023. Oral GVHD is a rare and serious disease. GVHD is a major cause of morbidity and mortality with chronic GVHD being the leading cause of nonmalignant fatality post Hematopoietic Cell transplantation (HCT).

It is a clinical syndrome where donor-derived T-cells attack the patient's own tissues, in this case, the oral mucosa. There is currently no FDA approved local drug treatment of oral GVHD.