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

Yahoo

08-04-2025

Topline Results Expected Q2 2025
PITTSBURGH, April 08, 2025 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ('Lipella' or the 'Company'), a clinical-stage biotechnology company focused on developing innovative therapies for unmet medical needs, today announced the completion of enrollment in its Phase 2a multicenter, dose-ranging trial evaluating LP-310, a liposomal tacrolimus oral rinse for the treatment of oral lichen planus (OLP). The Phase 2a trial has now fully enrolled participants across all three dose cohorts (0.25 mg, 0.50 mg and 1.0 mg of tacrolimus) at seven U.S. study sites. Topline results from the final cohort (1.0 mg) remain on track for the second quarter of 2025 and will represent the most comprehensive clinical dataset to date for LP-310.
'The completion of enrollment in our Phase 2a trial marks an important step in advancing a non-steroidal, locally delivered treatment for oral lichen planus, an underserved condition with no FDA-approved therapies,' said Dr. Michael Chancellor, Co-Founder and Chief Medical Officer of Lipella Pharmaceuticals. 'We have already observed encouraging safety and efficacy signals in the first two dose cohorts, including clinically meaningful reductions in pain, ulceration and inflammation. With the final cohort now fully enrolled, we look forward to reporting topline results in the near term and believe this dataset will be critical in informing next steps for development and broader clinical strategy.'
About the Phase 2a TrialThe Phase 2a trial is a multicenter, dose-ranging study designed to evaluate the safety, tolerability and preliminary efficacy of LP-310 in adult patients with symptomatic oral lichen planus. 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. The study's primary objectives include assessing LP-310's safety profile and pharmacokinetics, while secondary endpoints evaluate its impact on pain, inflammation and oral ulceration using patient-reported and investigator-measured scoring systems.
About Oral Lichen Planus (OLP)OLP is a chronic, T-cell-mediated autoimmune disorder affecting the oral mucosa, often causing painful erosions, inflammation and ulcerative lesions. The condition impacts an estimated 6 million Americans, and there are currently no FDA-approved treatments available.
Next Steps in DevelopmentWith enrollment complete, Lipella remains on track to:
Report topline results from the 1.0 mg cohort in the first half of 2025
Submit an Investigational New Drug (IND) application for a Phase 2b trial in late 2025
Explore potential regulatory designations, including Breakthrough Therapy designation
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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CONTACT Jonathan Kaufman Chief Executive Officer Lipella Pharmaceuticals Inc. [e-mail]1-412-894-1853
PCG Advisory Jeff Ramson [e-mail]