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Lipella Pharmaceuticals Announces Completion of Site Initiation Visit for Phase 2a Trial of LP-310 in Oral Lichen Planus
PITTSBURGH, May 31, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella,” “our,” “us” or the “Company”), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced the successful completion of its first Site Initiation Visit (SIV) for the Phase 2a trial evaluating LP-310 in the treatment of Oral Lichen Planus (OLP). With clearance received from the central Institutional Review Board (IRB), the Phase 2a trial is set to commence with site qualifications completed and patient recruitment underway.
Lipella’s Phase 2a trial is a multicenter, dose-ranging study involving adult male and female subjects experiencing symptomatic OLP. Approximately 24 subjects will be enrolled across five study sites in the United States. LP-310, Lipella's proprietary liposomal-tacrolimus (LP-10) oral rinse formulation, will be evaluated for safety, tolerability, and efficacy at doses of 0.25 mg, 0.5 mg, and 1.0 mg of tacrolimus. The trial, registered on ClinicalTrials.gov (NCT06233591), aims to address the unmet need for an effective treatment for OLP, a condition that currently lacks FDA-approved therapies.
Participants in the study will undergo screening, treatment, and follow-up phases. During the treatment phase, they will use a 10 mL LP-10 oral rinse for 3 minutes twice a day for 4 weeks, followed by a single post-treatment visit 2 weeks after the last dose. The study is anticipated to conclude in mid-2025.
Participants in the study will undergo screening, treatment, and follow-up phases. During the treatment phase, they will use a 10 mL LP-10 oral rinse for 3 minutes twice a day for 4 weeks, followed by a single post-treatment visit 2 weeks after the last dose. The study is anticipated to conclude in mid-2025.
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