Lipella Pharmaceuticals Completes Dosing of First Cohort in Phase 2a Trial of LP-310; Top-Line Data Expected by Year-End
Today the clinical-stage biotechnology company focused on innovative therapies for serious diseases with significant unmet needs, Lipella Pharmaceuticals Inc. (LIPO) announced the completion of dosing for the first cohort in its multi-center Phase 2a clinical trial of LP-310, a liposomal-tacrolimus oral rinse being developed for the treatment of Oral Lichen Planus (OLP).
First Dosing of Phase 2a Trial Highlights:
- Eight participants received a dose of 0.25 mg LP-310, with promising initial results and no product-related serious adverse events reported.
- Pharmacokinetic data demonstrated that whole blood tacrolimus levels in all patients were either undetectable or minimal, highlighting LP-310’s potential to deliver localized therapeutic effects while minimizing systemic exposure.
- All patients tolerated LP-310 without significant adverse reactions.
Following a successful internal safety evaluation of the first dose cohort, the trial has received approval to proceed to the next stage of the trial. This stage will evaluate a higher dose of 0.5 mg of LP-310.
Janet Okonski, Director of Clinical Operations at Lipella Pharmaceuticals, noted feedback from the study site, stating, “The tolerability observed in this initial cohort is a promising indicator. Oral Lichen Planus severely affects patient quality of life, and an effective, well-tolerated treatment is desperately needed. It’s encouraging to see this kind of response at an early stage.”
The company’s dedication to developing a safe and effective therapy for Oral Lichen Planus patients continues to be persistent as they begin to activate additional sites and begin enrolling the next dose cohort. The pace of Lipella’s promising progress puts them on track to deliver top-line data by year-end and complete the trial by mid-2025.
About Oral Lichen Planus (OLP)
Oral Lichen Planus (OLP) is a chronic inflammatory condition that affects the mucous membranes inside the mouth, which can cause pain and make eating, drinking and even speaking uncomfortable. Characterized by symptoms such as burning pain, white patches, swollen tissue, and open sores, OLP impacts approximately 6 million Americans and currently has no FDA-approved therapies.
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