Lipella Pharma's LP-310 Receives FDA Orphan Designation

Pittsburgh, Pennsylvania-based Lipella Pharmaceuticals Inc., a pharmaceutical company in the clinical stage focusing on serious diseases with significant unmet need, has received "Orphan Drug Designation" from the US Food and Drug Administration (FDA) for its drug candidate, LP-310, designed to treat oral graft-versus-host disease (GvHD). The LP-310 is Lipella's clinical stage pipeline asset designed for treating inflammatory diseases in the mouth, such as oral lichen planus and oral GvHD. Introducing LP-310, a liposomal tacrolimus oral rinse created by Lipella. This formulation is based on their top drug candidate , LP-10.

Lipella has just obtained FDA clearance for a phase 2a clinical trial to assess the safety and effectiveness of LP-310 in patients with symptomatic oral lichen planus, a condition that currently lacks FDA-approved treatment and can significantly affect a patient's quality of life. "According to Michael Chancellor, the chief medical officer at Lipella, GvHD occurs when immune cells from a donor attack the body tissues of the recipient following a tissue or bone marrow transplant from a different individual." About 30,000 Americans are affected by GvHD, and oral GvHD is a major contributor to illness in cancer survivors Oral GvHD causes substantial oral pain and discomfort, making it challenging for patients to eat, drink, and speak. Furthermore, the likelihood of developing oral cavity infection, fibrosis, and even oral cancer also rises. The impact of Oral GvHD on the quality of life for patients is significant, and it represents a substantial unmet need for cancer survivors.