New York, N.Y., March 06, 2024 - PRISM MarketView - Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) has received FDA approval of an Investigational New Drug (IND) application for clinical testing of LP-410 in the treatment of oral Graft-Versus-Host Disease (GvHD). Lipella expects to commence its clinical study in the second half of 2024.
“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. Jonathan Kaufman, CEO of Lipella
“We believe that Lipella’s proprietary oral rinse formulation of liposomal tacrolimus has the potential to effectively treat oral GVHD, while minimizing systemic toxicity.”
Dr. Michael Chancellor, Lipella’s Chief Medical Officer
Lipella is also advancing liposomal tacrolimus for the treatment of hemorrhagic cystitis (LP-10) and oral lichen planus (LP-310). The addition of this clinical asset is a significant expansion to the company’s pipeline, which comprises three IND-approved assets, two of which have been granted Orphan Disease Designation by the FDA.
Highlights
LP-410 targets the underlying mechanisms of oral GvHD, potentially providing a safe and effective treatment option.
Oral GvHD is a serious rare disease characterized by sensitivity and pain, and affects a patient’s ability to eat, drink and speak. In addition, the risk of oral cavity infection, fibrosis and even oral cancer increases. Oral GvHD currently has no FDA approved local drug treatment.
In November 2023, Lipella was granted FDA Orphan Drug Designation on tacrolimus for treatment of GvHD. The FDA’s “Orphan Drug Designation” program provides orphan status to drugs and biologics that are intended for the treatment, prevention or diagnosis of a rare disease or condition that affects fewer than 200,000 people in the United States.
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.
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