Lipella Pharmaceuticals Announces Positive Phase 2a Results for Oral Lichen Planus Treatment

Lipella Pharmaceuticals has reported promising topline results from the second cohort of its Phase 2a trial evaluating LP-310, a liposomal-tacrolimus oral rinse, as a treatment for oral lichen planus (OLP), a chronic inflammatory condition with no current FDA-approved therapies. Data showed statistically significant improvements in symptoms, including reductions in investigator assessment scores, reticulation and ulceration scores, and patient-reported pain, with benefits observed as early as week one and continuing through week four. The treatment demonstrated a strong safety profile with no serious adverse events and full patient adherence, while pharmacokinetic analyses indicated no detectable systemic exposure to tacrolimus, highlighting its localized action. The trial has now fully enrolled all three planned dose groups, with final data from the highest dose cohort anticipated in the second quarter of 2025. Lipella plans to submit an IND application for a Phase 2b trial later in 2025 and aims to seek FDA Breakthrough Therapy designation to expedite development. These results represent a significant step forward for patients with OLP, addressing a major unmet clinical need.