Lipella Pharmaceuticals Announces FDA Clearance of IND for LP-310 for Oral Lichen Planus
- FDA approval for LP-310 clinical trial is a positive development for Lipella Pharmaceuticals
- LP-310 has the potential to address the unmet need for effective treatment of oral lichen planus
- The clinical trial will assess the safety and efficacy of LP-310 in patients with symptomatic OLP
- None.
LP-310 is an oral formulation of Lipella's lead asset LP-10.
In March 2023, Lipella created a five-member Scientific Advisory Board in Oral Health, made up of a group of highly regarded experts in oral medicine, to focus on the development of LP-310. This team helped craft the clinical strategy and will be involved in the recruitment of high-quality clinical sites.
Dr. Jonathan Kaufman, CEO of Lipella, said, "This FDA approval demonstrates our ability to significantly advance our value proposition by adding a phase-2, clinical-stage asset to our pipeline."
Dr. Michael Chancellor, Lipella's Chief Medical Officer, said, "OLP is a painful oral mucosal disease that currently has no approved therapy. We look forward to the opportunity to develop an effective treatment."
About Oral Lichen Planus
Oral Lichen Planus (OLP) is a chronic, inflammatory, T-cell-mediated, autoimmune oral mucosal disease. It is a painful condition with malignant potential, and complications include infections, scarring, stress and depression. OLP affects between one and four percent of the world's population. Most currently available therapies are palliative rather than curative.
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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CONTACT
Dr. Jonathan Kaufman, CEO
Lipella Pharmaceuticals
Info@Lipella.com
1-412-894-1853
Jeff Ramson
PCG Advisory
jramson@pcgadvisory.com
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SOURCE Lipella Pharmaceuticals Inc.
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