Lipella Pharmaceuticals Granted FDA Orphan Designation for Oral Graft-versus-Host Disease Drug
November 10, 2023 at 11:17 am - by Catie Corcoran
Lipella Pharmaceuticals(Nasdaq: LIPO) has received Orphan Drug Designation for its LP-310 drug candidate for oral Graft-versus-Host Disease (GvHD). LP-310 is the company’s clinical stage asset formulated for delivering active agents to the oral cavity for diseases of the mouth including oral lichen planus and oral GvHD.
Lipella’s LP-10 was previously granted Orphan Drug Designation by the FDA, making LP-310 the second of Lipella’s leading product candidates to receive this designation.
Dr. Jonathan Kaufman, Ph.D., Chief Executive Officer of Lipella, 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.”
Highlights
LP-310 liposomal tacrolimus is a proprietary oral rinse formulation of Lipella’s lead drug candidate, LP-10.
Lipella recently received FDA clearance for a Phase 2a clinical trial to evaluate LP-310’s safety and efficacy in patients with symptomatic oral lichen planus, which currently has no FDA approved treatment, and can severely impact a patient’s quality of life.
Dr. Michael Chancellor, Chief Medical Officer at Lipella, said, “GvHD affects approximately 30,000 Americans and oral GvHD contributes significantly to morbidity in cancer survivors. Morbidity of oral GvHD encompasses significant oral pain and discomfort, making it difficult for patients to eat, drink and speak. In addition, the risk of oral cavity infection, fibrosis and even oral cancer increases. Oral GvHD is a great unmet need in cancer survivors.”
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.
Orphan Drug Designation qualifies sponsors for incentives, including tax credits for qualified clinical trials, exemption from user fees and a potential seven years of market exclusivity after approval.
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 visitwww.lipella.com or LinkedIn.
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