Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) has 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). The early results suggest a potential breakthrough in treating this chronic inflammatory condition affecting millions.
Promising Initial Results
In the first cohort, eight participants received a 0.25 mg dose of LP-310. The initial results were promising, with no product-related serious adverse events reported. Pharmacokinetic data indicated that whole blood tacrolimus levels in all patients were either undetectable or minimal, suggesting LP-310's potential to deliver localized therapeutic effects while minimizing systemic exposure. All patients tolerated LP-310 without significant adverse reactions.
Janet Okonski, Director of Clinical Operations at Lipella Pharmaceuticals, highlighted the significance of these findings: "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."
Advancing to Higher Dose
Following a successful internal safety evaluation of the first dose cohort, the trial has received approval to advance to the next stage, which will evaluate a higher dose of 0.5 mg of LP-310. This dose-ranging study will further assess the safety, tolerability, and efficacy of LP-310.
Addressing Unmet Needs in OLP Treatment
Oral Lichen Planus (OLP) is a chronic inflammatory condition affecting the mucous membranes inside the mouth. It can cause pain and make eating, drinking, and even speaking uncomfortable. Symptoms include burning pain, white patches, swollen tissue, and open sores. OLP impacts approximately 6 million Americans, and currently, there are no FDA-approved therapies available.
Dr. Michael Chancellor, Chief Medical Officer of Lipella Pharmaceuticals, stated, "Our commitment to developing a safe and effective therapy for Oral Lichen Planus patients remains steadfast as we activate additional sites and begin enrolling the next dose cohort. The pace of our progress has been promising, and we are on track to deliver top-line data by year-end and complete the trial by mid-2025."
Study Design and Timeline
The Phase 2a clinical trial is a multicenter, dose-ranging study involving adult male and female subjects (18 years and older) with symptomatic OLP. The study evaluates the safety, tolerability, and efficacy of LP-310 at doses of 0.25 mg, 0.5 mg, and 1.0 mg of tacrolimus. Seven sites across the U.S. are actively recruiting participants. The clinical trial is expected to conclude by mid-2025, with top-line data anticipated by year-end 2024.
