Lipella Pharmaceuticals Begins Dosing in Phase 2a Oral Lichen Planus Trial

On August 12, 2024, Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) announced that it has started dosing the first two patients in its Phase 2a clinical trial of LP-310, a novel treatment for Oral Lichen Planus (OLP). OLP is a chronic inflammatory condition that impacts the mucous membranes in the mouth, leading to symptoms such as burning pain, white patches, swollen tissue, and open sores. Affecting around 6 million Americans, OLP currently has no FDA-approved treatments.

The Phase 2a trial conducted by Lipella is a multicenter, dose-ranging study focusing on adult male and female patients who exhibit symptoms of OLP. The study is projected to wrap up by mid-2025, with top-line data expected to be released by the end of 2024. LP-310, the investigational drug being tested, is a novel liposomal-tacrolimus oral rinse developed from Lipella's lead candidate LP-10, which is also under evaluation for another condition, hemorrhagic cystitis.

Dr. Michael Chancellor, the Chief Medical Officer of Lipella, highlighted the significant hurdles posed by Oral Lichen Planus, including severe pain, infection risks, scarring, and the potential for malignant transformation. He emphasized that current treatments are mainly palliative and that the psychological burden on patients exacerbates the condition. Dr. Chancellor stated that Lipella aims to address the underlying mechanisms of OLP with LP-310, seeking to achieve considerable symptom relief and lower the risk of complications, ultimately delivering the first approved drug treatment for OLP to this underserved patient population.

Dr. Michael Brennan, the Chairman of the Department of Oral Medicine/Oral & Maxillofacial Surgery and principal investigator at Atrium Health Carolinas Medical Center, emphasized the importance of this trial. He noted that the initiation of the trial is a critical step towards addressing the significant deficiency in effective treatments for OLP. Dr. Brennan stressed the urgent need for FDA-approved therapies, pointing out that patients are eager for new treatment options.

Oral Lichen Planus is a debilitating condition marked by oral mucosal lesions, affecting millions globally. It presents substantial challenges in terms of management and treatment, with current therapeutic options being limited. This underscores the critical need for innovative approaches like LP-310 in addressing this significant medical need.

Lipella Pharmaceuticals is a clinical-stage biotechnology company dedicated to developing new medications by reformulating active agents in existing generic drugs and optimizing these reformulations for new applications. The company focuses on treating diseases with substantial, unaddressed morbidity and mortality where no approved drug therapies currently exist. Lipella completed its initial public offering in December 2022.