Lipella Pharmaceuticals Completes First Cohort in Phase 2a Trial of LP-310 for Oral Lichen Planus, Moves to Next Dose Group

PITTSBURGH, Nov. 21, 2024 - Lipella Pharmaceuticals Inc. (Nasdaq: LIPO), a company in the clinical-stage biotechnology sector, has achieved a significant milestone. They have successfully completed the dosing for the first cohort in their multi-center Phase 2a clinical trial of LP-310. This innovative treatment, a liposomal-tacrolimus oral rinse, is being developed for individuals suffering from Oral Lichen Planus (OLP).

The initial cohort consisted of eight participants who received a dose of 0.25 mg LP-310. The preliminary outcomes have been promising, with no serious adverse events linked to the product being reported. Pharmacokinetic data revealed that the levels of tacrolimus in the blood of all patients were either undetectable or very low. This suggests that LP-310 has the potential to provide localized therapeutic effects while minimizing systemic exposure. Moreover, all patients tolerated LP-310 well, without experiencing significant adverse reactions.

Janet Okonski, Director of Clinical Operations at Lipella Pharmaceuticals, emphasized the positive feedback received from the study site. She stated, "The tolerability observed in this initial cohort is a promising indicator. Oral Lichen Planus severely affects patient quality of life, and an effective, well-tolerated treatment is desperately needed. It’s encouraging to see this kind of response at an early stage."

After a successful internal safety evaluation of the first dose cohort, the trial has been approved to proceed to the next stage. This phase will evaluate a higher dose of 0.5 mg of LP-310. Dr. Michael Chancellor, Chief Medical Officer of Lipella Pharmaceuticals, expressed his gratitude to the investigators and study staff for their dedication. He said, "We are proud of this milestone and are grateful to our investigators and study staff for their dedication and hard work. Our commitment to developing a safe and effective therapy for Oral Lichen Planus patients remains steadfast as we activate additional sites and begin enrolling the next dose cohort. The pace of our progress has been promising, and we are on track to deliver top-line data by year-end and complete the trial by mid-2025."

Oral Lichen Planus (OLP) is a chronic inflammatory condition that affects the mucous membranes inside the mouth, causing pain and making eating, drinking, and speaking uncomfortable. Symptoms include burning pain, white patches, swollen tissue, and open sores. OLP affects approximately 6 million Americans and currently has no FDA-approved therapies.

The Oral Lichen Planus Clinical Trial is a multicenter, dose-ranging study involving adult male and female subjects aged 18 years and older with symptomatic OLP. The study aims to evaluate the safety, tolerability, and efficacy of LP-310 at doses of 0.25 mg, 0.5 mg, and 1.0 mg of tacrolimus. Seven sites across the U.S. are now active and recruiting participants for the trial. The clinical trial is expected to conclude by mid-2025, with top-line data anticipated by the end of 2024. The early results suggest that LP-310 could be a breakthrough treatment for OLP, significantly improving patients' quality of life.

Lipella Pharmaceuticals Inc. is a clinical-stage biotechnology company focused on developing new drugs by reformulating active agents in existing generic drugs and optimizing these reformulations for new applications. The company targets diseases with significant unmet needs, where no approved drug therapies currently exist. Lipella completed its initial public offering in 2022.