Lipella Pharmaceuticals Completes Enrollment in Phase 2a Trial of LP-310 for Oral Lichen Planus

Core Insights - Lipella Pharmaceuticals has completed enrollment in its Phase 2a trial for LP-310, a liposomal tacrolimus oral rinse aimed at treating oral lichen planus (OLP) [1][2] - The trial includes three dose cohorts (0.25 mg, 0.50 mg, and 1.0 mg) and has fully enrolled participants across seven U.S. study sites [1][3] - Topline results from the final cohort (1.0 mg) are expected in the second quarter of 2025, which will provide the most comprehensive clinical dataset for LP-310 to date [1][2] Phase 2a Trial Details - The Phase 2a trial is a multicenter, dose-ranging study assessing the safety, tolerability, and preliminary efficacy of LP-310 in adult patients with symptomatic OLP [3] - The trial consists of three dose levels (0.25 mg, 0.50 mg, and 1.0 mg), administered as a twice-daily 10-milliliter oral rinse over four weeks [3] - Primary objectives include evaluating LP-310's safety profile and pharmacokinetics, while secondary endpoints focus on pain, inflammation, and oral ulceration [3] Oral Lichen Planus (OLP) Overview - OLP is a chronic autoimmune disorder affecting the oral mucosa, causing painful erosions, inflammation, and ulcerative lesions [4] - The condition impacts an estimated 6 million Americans, with no FDA-approved treatments currently available [4] Next Steps in Development - Following the completion of enrollment, Lipella plans to report topline results from the 1.0 mg cohort in the first half of 2025 [7] - The company aims to submit an Investigational New Drug (IND) application for a Phase 2b trial in late 2025 [7] - Lipella will explore potential regulatory designations, including Breakthrough Therapy designation [7] Company Background - Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing new drugs by reformulating existing generic drugs for new applications [5] - The company targets diseases with significant unmet needs where no approved drug therapies exist [5] - Lipella completed its initial public offering in 2022 [5]