• LP-310 is an oral formulation of Lipella's lead asset LP-10.

PITTSBURGH, Oct. 20, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: "LIPO") ("Lipella," "our, "us" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announces that the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for a multi-center, phase-2a, dose-escalation clinical trial to assess the safety and efficacy of LP-310 in patients with symptomatic oral lichen planus (OLP), a highly morbid condition with no effective treatment.

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.

Forward-Looking Statements

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CONTACT
Dr. Jonathan Kaufman, CEO
Lipella Pharmaceuticals
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1-412-894-1853

Jeff Ramson
PCG Advisory
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