Lipella Pharmaceuticals Completes Site Initiation for LP-310 Phase 2a Oral Lichen Planus Trial

Lipella Pharmaceuticals Inc., a clinical-stage biotechnology firm listed on Nasdaq under the ticker LIPO, has announced the completion of its first Site Initiation Visit (SIV) for the Phase 2a clinical trial assessing LP-310 for the treatment of Oral Lichen Planus (OLP). Following the green light from the central Institutional Review Board (IRB), preparations for the trial have been finalized, and patient recruitment is actively ongoing.

The Phase 2a trial is designed as a multicenter, dose-ranging study that will include adult patients, both male and female, suffering from symptomatic OLP. The study plans to enroll approximately 24 participants across five sites in the United States. The trial will evaluate the safety, tolerability, and efficacy of Lipella's proprietary oral rinse formulation of liposomal-tacrolimus, known as LP-310, at dosages of 0.25 mg, 0.5 mg, and 1.0 mg of tacrolimus. The trial is registered on ClinicalTrials.gov under the identifier NCT06233591 and aims to address the current lack of FDA-approved therapies for OLP.

Participants in the study will undergo a thorough process that includes screening, treatment, and follow-up phases. During the treatment phase, participants will use a 10 mL LP-310 oral rinse twice daily for four weeks, with each rinse lasting three minutes. A follow-up visit will be conducted two weeks after the final dose. The trial is expected to be completed by mid-2025.

Dr. Jonathan Kaufman, CEO of Lipella, expressed his excitement about the progress, stating, "We are extremely pleased to announce the successful completion of the Site Initiation Visit for our Phase 2a trial of LP-310. This milestone brings us one step closer to providing a potential treatment for the approximately 6 million Americans affected by OLP, a condition that causes significant pain and has no approved therapies."

Dr. Michael Chancellor, Chief Medical Officer of Lipella, emphasized the importance of the trial. He noted, "OLP is a painful oral mucosal disease with no approved therapy. We are optimistic that Lipella's proprietary oral rinse formulation of liposomal tacrolimus offers significant potential in treating OLP while minimizing systemic toxicity. I eagerly anticipate working with the principal investigators to ensure a safe and seamless trial process."

Oral Lichen Planus (OLP) is a serious condition characterized by painful lesions in the oral mucosa. It affects millions of individuals worldwide and poses significant challenges in terms of management and treatment. Current therapeutic options are very limited, highlighting the urgent need for innovative treatments like LP-310.

Lipella Pharmaceuticals is focused on developing new drugs by reformulating existing generic drugs and optimizing these reformulations for new applications. The company specializes in addressing diseases with significant, unmet needs where no approved drug therapies currently exist. Lipella went public in December 2022.

While the clinical trial marks a significant step forward for Lipella, the company remains cautious about forward-looking statements. These statements, which may include the company's strategy, future operations, and financial position, are based on current expectations and are subject to risks and uncertainties. Lipella advises caution in relying on such statements and commits to updating them only as required by law.

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