Lipella Reports Positive Phase 2a Results from Second LP-310 Cohort in Oral Lichen Planus; Final Data Expected Q2 2025

Core Insights - Lipella Pharmaceuticals announced positive topline results from the second cohort of its Phase 2a trial for LP-310, a liposomal-tacrolimus oral rinse for treating oral lichen planus (OLP) [1][2] - The trial has fully enrolled participants across all three planned dose cohorts, with the next step being the submission of an Investigational New Drug (IND) application for a Phase 2b trial [3][8] Efficacy and Safety - Treatment with LP-310 at the 0.50 mg dose showed statistically significant improvements in multiple efficacy endpoints, indicating its potential as a non-steroidal therapy for OLP [2][5] - The safety profile of LP-310 remains strong, with no treatment-related serious adverse events (SAEs) and full adherence to the treatment regimen [5][6] Clinical Data - Key findings from the 0.50 mg cohort include: - Investigator Global Assessment (IGA) improved from 3.42 ± 0.21 at baseline to 2.71 ± 0.30 at week 1 (p=0.029) and 1.71 ± 0.43 at week 4 (p=0.007) [7] - Reticulation, Erythema and Ulceration (REU) Score decreased from 26.91 ± 2.54 at baseline to 17.02 ± 2.36 at week 1 (p=0.003) [7] - Oral Lichen Planus Symptom Severity Measure (OLPSSM) decreased from 14.92 ± 2.10 at baseline to 9.87 ± 2.27 at week 1 (p=0.032) [7] - Pain Numerical Rating Scale (NRS) improved from 6.42 ± 0.75 at baseline to 4.25 ± 0.89 at week 1 (p=0.003) [7] Future Development - The company is preparing to report final topline results from the 1.0 mg cohort in Q2 2025, which will inform regulatory interactions and further clinical advancement [8][9] - Lipella aims to pursue FDA Breakthrough Therapy designation to expedite the development process for LP-310 [9] Company Overview - Lipella Pharmaceuticals is focused on developing innovative therapies for serious diseases with significant unmet needs, utilizing reformulated existing drugs for new applications [13]