Lipella Pharmaceuticals announces final results from Phase 2a study of LP-10

Lipella Pharmaceuticals (LIPO) announced final results from its completed Phase 2a multicenter, dose-ranging study evaluating LP-10, a proprietary liposomal tacrolimus oral rinse, in patients with symptomatic oral lichen planus. The study met its primary safety endpoint and achieved statistically significant improvements across all efficacy measures at the 4-week timepoint. These results support LP-10’s potential to become the first FDA-approved therapy for OLP, a chronic inflammatory condition that affects an estimated 6 million Americans, with no approved treatment options. Safety Profile: All 27 patients completed the full 4-week treatment course; No serious adverse events reported; Minimal systemic exposure: 76% of tacrolimus blood measurements were below detection limits; Well-tolerated, with only mild to moderate treatment-related adverse events; dry mouth being the most common, occurring in 18.5% of patients. Efficacy Outcomes: All three dose groups demonstrated statistically significant improvements at Week 4 on the secondary efficacy endpoints: Investigator Global Assessment showed clear reductions in ulceration and erythema scores; Pain and Sensitivity improved significantly, with patients reporting meaningful reductions on numerical rating scales; Patient symptoms, as measured by the OLP Symptom Severity Measure, demonstrated meaningful improvement in overall symptom burden; Sustained efficacy was observed, with all patients maintaining clinical benefit and no evidence of worsening through the 2-week follow-up period. The Phase 2a study was a multicenter, dose-ranging trial conducted at five leading U.S. clinical sites. Twenty-seven adults with biopsy-confirmed symptomatic OLP were sequentially enrolled into three dose cohorts. Patients used a 3-minute LP-10 oral rinse twice daily for 4 weeks, followed by a 2-week safety follow-up. The study population was representative of typical OLP patients: 81.5% were female, the median age was 62 years, and disease duration ranged from 1 to 28 years. All participants had previously failed standard therapies, including topical corticosteroids. Based on these results, Lipella is advancing LP-10 into late-stage development: Preparation of Phase 2b protocol incorporating FDA feedback; Scaling manufacturing capabilities to support larger clinical trials; Exploring strategic partnerships and collaborations