Therapy Areas: Inflammatory Diseases
Lipella Pharmaceuticals' LP-310receives US FDA 'Orphan Drug Designation'
13 November 2023 -

Lipella Pharmaceuticals Inc (Nasdaq: LIPO), a US-based clinical stage pharmaceutical company, announced on Friday that it has received 'Orphan Drug Designation' from the US Food and Drug Administration (FDA) for its drug candidate, LP-310 intended for the treatment of oral Graft-versus-Host Disease (GvHD).

LP-310 is Lipella's clinical stage pipeline asset intended to be indicated for inflammatory diseases of the oral cavity, including oral lichen planus and oral GvHD. It is a proprietary oral rinse formulation of Lipella's lead drug candidate, LP-10.

Lipella recently received FDA approval for a Phase 2a clinical trial to assess the product's safety and efficacy in subjects with symptomatic oral lichen planus that presently has no FDA approved treatment, and can severely affect a patient's quality of life.

Dr Jonathan Kaufman, PhD, Lipella chief executive officer, said: "We are very pleased to have received Orphan Drug Designation for LP-310 in oral GvHD. This designation is an example of the way we build value, pursuing all available resources that can de-risk and accelerate our clinical research programs. Our collaborative practice with the FDA is critical to our ability to increase the value of all of our clinical assets. We look forward to advancing this drug as a potential treatment for this painful complication of chronic GvHD."