Lipella Pharmaceuticals Announces Positive Early Tolerability in Phase 2a Trial of LP-310 for Oral Lichen Planus

PITTSBURGH, Sept. 24, 2024 – Lipella Pharmaceuticals Inc. (Nasdaq: LIPO), a biotechnology firm in the clinical stage, has provided an update on its ongoing Phase 2a clinical trial for LP-310, an oral rinse being tested for treating Oral Lichen Planus (OLP). This study, which spans multiple centers, aims to address a significant unmet medical need.

The company revealed that three participants have completed the four-week treatment regimen with LP-310. The initial results are promising, indicating that the treatment is well tolerated and has no unpleasant taste. Dr. Michael Chancellor, Chief Medical Officer at Lipella Pharmaceuticals, stated that OLP is a condition that disrupts patients' daily lives significantly. He emphasized that tolerability is crucial due to the severe symptoms of OLP. Current treatments often cause symptomatic side effects leading to dose interruptions or delays, complicating disease management. He expressed optimism that LP-310’s tolerability without an unpleasant taste is a positive sign. He looks forward to collecting more safety data as the trial progresses.

LP-310 is a specialized liposomal-tacrolimus formulation derived from Lipella's leading candidate, LP-10, initially developed for hemorrhagic cystitis. This innovative formulation targets the underlying causes of OLP and aims to be a more effective alternative to current palliative treatments by delivering a concentrated therapeutic effect directly to the oral cavity while minimizing systemic toxicity. At present, there are no FDA-approved pharmacotherapies for OLP, and LP-310 is the sole topical treatment in development for this condition.

The Oral Lichen Planus Clinical Trial is a multicenter, dose-ranging study involving adults aged 18 and older who have symptomatic OLP. This trial will assess the safety, tolerability, and efficacy of LP-10 at different doses: 0.25 mg, 0.5 mg, and 1.0 mg of tacrolimus. Five sites across the United States are currently active and recruiting participants. The study is expected to be completed by mid-2025, with top-line data anticipated by the end of 2024. Early results suggest that LP-310 could be a groundbreaking treatment for OLP, a condition that severely affects patients' quality of life.

Lipella Pharmaceuticals, a clinical-stage biotechnology company, focuses on developing new drugs by reformulating active agents in existing generic drugs for new applications. The company targets diseases with significant unmet needs, where no approved drug therapy currently exists. Lipella completed its initial public offering in December 2022.