Lipella Pharmaceuticals has announced positive final results from its Phase IIa study of LP-10, a proprietary liposomal tacrolimus oral rinse, in patients with symptomatic oral lichen planus (OLP).
The completed multicenter, dose-ranging trial (NCT06233591) met its primary safety endpoint and achieved statistically significant improvements across all efficacy measures at the four-week mark.
Lichen planus is an inflammatory condition that affects the skin and mucous membranes. It often appears as itchy, purple, flat-topped bumps on the skin and may cause lacy white patches in the mouth. The exact cause of lichen planus is unknown, but it is believed to be related to an immune reaction or triggered by certain medications, chemicals, or viruses such as hepatitis C.
Currently, no US Food and Drug Administration (FDA) approved therapies exist for OLP, leaving patients to rely on off-label treatments that often deliver limited benefit.
Based on the Phase IIa results, the US-based company plans to initiate a pivotal Phase IIb trial, scale up manufacturing, and explore strategic partnerships. “We believe LP-10 represents a paradigm shift in OLP treatment, if approved,” said Jonathan Kaufman, CEO and co-founder of Lipella.
Clinical Trial Results
All 27 participants completed treatment with no serious adverse events. The most common treatment-related effect was mild dry mouth, observed in fewer than one in five patients. Notably, systemic absorption of tacrolimus was minimal, with the majority of blood measurements below detection limits.
Efficacy outcomes showed consistent improvements across multiple endpoints, including reductions in ulceration and erythema, decreased pain and sensitivity, and a meaningful decline in overall symptom burden as measured by the OLP Symptom Severity Measure. Benefits were sustained through a two-week follow-up period.
“Investigator examinations revealed significant healing, including visible resolution of ulcerative lesions,” said Dr. Michael Chancellor, Chief Medical Officer and co-founder of Lipella. “These findings were strongly reinforced by patient-reported outcomes, highlighting LP-10’s potential to address this debilitating condition.”
The study enrolled adults with biopsy-confirmed OLP at five US clinical sites. Participants, most of whom were women with a median age of 62, had long disease histories and prior treatment failures with standard therapies such as corticosteroids.
The company intends to present full study results at upcoming medical conferences and submit findings for peer-reviewed publication.
