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Highlights

  • Lipella completes enrollment in Phase 2a trial for LP-310 in oral lichen planus
  • The trial includes three dose cohorts, with topline results expected in Q2 2025
  • Oral lichen planus affects millions, with no FDA-approved treatments available

Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) has announced the completion of participant enrollment in its Phase 2a clinical trial for LP-310, a liposomal tacrolimus oral rinse designed to treat oral lichen planus (OLP), a condition that currently has no FDA-approved treatments. This trial, which includes three different dose cohorts (0.25 mg, 0.50 mg, and 1.0 mg), has successfully enrolled participants across seven U.S. study sites.

The Phase 2a trial is a multicenter, dose-ranging study focused on assessing the safety, tolerability, and preliminary efficacy of LP-310 in patients suffering from symptomatic oral lichen planus. In addition to evaluating LP-310's safety profile, the trial also aims to examine its impact on inflammation, pain, and oral ulceration through both patient-reported and investigator-measured scoring systems.

With the final cohort now fully enrolled, Lipella expects topline results from the 1.0 mg group in the second quarter of 2025. This data is expected to provide the most comprehensive clinical insights to date for LP-310, which could significantly contribute to the development of treatments for OLP.

Oral lichen planus is a chronic autoimmune disorder that affects the oral mucosa, causing painful lesions, inflammation, and ulcerations. Affecting around 6 million Americans, the condition remains without an FDA-approved treatment. The completion of this trial enrollment represents a critical milestone in Lipella's efforts to develop a non-steroidal, locally delivered treatment for this underserved medical need. Following the topline results, Lipella plans to submit an Investigational New Drug (IND) application in late 2025 to move forward with further clinical trials.