LIPO Lipella Pharmaceuticals Inc

Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company focused on innovative therapies for serious diseases with significant unmet needs, today announced the completion of dosing for the first cohort in its multi-center Phase 2a clinical trial of LP-310, a liposomal-tacrolimus oral rinse being developed for the treatment of Oral Lichen Planus (OLP).

In this first cohort, eight participants received a dose of 0.25 mg LP-310, with promising initial results. No product-related serious adverse events were reported. Pharmacokinetic data demonstrated that whole blood tacrolimus levels in all patients were either undetectable or minimal, highlighting LP-310’s potential to deliver localized therapeutic effects while minimizing systemic exposure. Additionally, all patients tolerated LP-310 without significant adverse reactions.

Janet Okonski, Director of Clinical Operations at Lipella Pharmaceuticals, noted feedback from the study site, stating, “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.”

Following a successful internal safety evaluation of the first dose cohort, the trial has received approval to advance to the next stage of the trial, which will evaluate a higher dose of 0.5 mg of LP-310.

“We are proud of this milestone and are grateful to our investigators and study staff for their dedication and hard work,” said Dr. Michael Chancellor, Chief Medical Officer of Lipella Pharmaceuticals. “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, which can cause pain and make eating, drinking and even speaking uncomfortable. Characterized by symptoms such as burning pain, white patches, swollen tissue, and open sores, OLP impacts approximately 6 million Americans and currently has no FDA-approved therapies.

About the StudyThe Oral Lichen Planus Clinical Trial is a multicenter, dose-ranging study involving adult male and female subjects (18 years and older) with symptomatic OLP. This study will evaluate the safety, tolerability and efficacy of LP-10 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. For more information, please visit https://lipella.com/oral-lichen-planus-treatment/ or https://clinicaltrials.gov/study/NCT06233591.

The clinical trial is expected to conclude by mid-2025, with top-line data anticipated by year-end 2024. The early results indicate the potential of LP-310 as a breakthrough treatment for OLP, a condition that severely impacts patients' quality of life.

About Lipella Pharmaceuticals Inc.Lipella Pharmaceuticals 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. Lipella targets diseases with significant unmet needs, where no approved drug therapies currently exist. The company completed its initial public offering in 2022. Learn more at lipella.com and follow us on X and LinkedIn.

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CONTACTDr. Jonathan Kaufman, CEOLipella PharmaceuticalsInfo@Lipella.com1-412-894-1853

Jeff RamsonPCG Advisoryjramson@pcgadvisory.com646-863-6893