Lipella Pharmaceuticals Announces FDA Clearance of IND for LP-410 for Oral Graft-Versus-Host Disease, Advancing Clinical Pipeline

Clinical testing of LP-410 expected to commence in Q2 2024

PITTSBURGH, March 05, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: “LIPO”) (“Lipella,” “our, “us” or the “Company”), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today 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.”

Dr. Michael Chancellor, Lipella’s Chief Medical Officer, said, “Oral GVHD is a rare but serious oral mucosal disease that currently has no approved therapy. We believe that Lipella’s proprietary oral rinse formulation of liposomal tacrolimus has the potential to effectively treat oral GVHD, while minimizing systemic toxicity. The addition of this clinical asset is a significant expansion to our pipeline, which now comprises three IND-approved assets, two of which have been granted Orphan Disease Designation by the FDA. We are enthusiastic about our path forward.”

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.

About Oral GVHD
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.

About Lipella Pharmaceuticals
Lipella is a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications. Additionally, Lipella maintains a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella completed its initial public offering in December 2022. For more information, please visit www.lipella.com or LinkedIn.