Lipella Pharmaceuticals Announces Completion of Site Initiation Visit for Phase 2a Trial of LP-310 in Oral Lichen Planus

Clinical testing of LP-310 expected to commence in mid-2024

Patient recruitment is underway for Phase 2a multicenter, dose-ranging study

PITTSBURGH, May 31, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella,” “our,” “us” or the “Company”), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced the successful completion of its first Site Initiation Visit (SIV) for the Phase 2a trial evaluating LP-310 in the treatment of Oral Lichen Planus (OLP). With clearance received from the central Institutional Review Board (IRB), the Phase 2a trial is set to commence with site qualifications completed and patient recruitment underway.

Lipella’s Phase 2a trial is a multicenter, dose-ranging study involving adult male and female subjects experiencing symptomatic OLP. Approximately 24 subjects will be enrolled across five study sites in the United States. LP-310, Lipella's proprietary liposomal-tacrolimus (LP-10) oral rinse formulation, will be evaluated for safety, tolerability, and efficacy at doses of 0.25 mg, 0.5 mg, and 1.0 mg of tacrolimus. The trial, registered on (NCT06233591), aims to address the unmet need for an effective treatment for OLP, a condition that currently lacks FDA-approved therapies.

Participants in the study will undergo screening, treatment, and follow-up phases. During the treatment phase, they will use a 10 mL LP-10 oral rinse for 3 minutes twice a day for 4 weeks, followed by a single post-treatment visit 2 weeks after the last dose. The study is anticipated to conclude in mid-2025.

Dr. Jonathan Kaufman, CEO of Lipella, expressed his enthusiasm, stating, “We are extremely pleased to announce the completion of the Site Initiation Visit for our Phase 2a trial of LP-310. This milestone brings us one step closer to providing a potential treatment for the estimated 6 million Americans affected by OLP, a condition that causes significant pain and has no approved therapies.”

Dr. Michael Chancellor, Chief Medical Officer of Lipella, highlighted the significance of the trial, noting, “OLP presents as a painful oral mucosal disease with no approved therapy. We are optimistic that Lipella's proprietary oral rinse formulation of liposomal tacrolimus offers significant potential in treating OLP while minimizing systemic toxicity. I eagerly anticipate collaborating with the principal investigators to ensure a safe and seamless trial process.”

About Oral Lichen Planus
Oral Lichen Planus (OLP) is a serious and debilitating condition characterized by oral mucosal lesions. It affects millions of individuals worldwide and presents significant challenges in terms of management and treatment. Current therapeutic options are limited, underscoring the critical need for innovative approaches like LP-310 in addressing this unmet medical need.

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 or LinkedIn.

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Dr. Jonathan Kaufman, CEO
Lipella Pharmaceuticals

Jeff Ramson
PCG Advisory