The trial aims to evaluate the efficacy and safety of LP-310, a new liposomal-tacrolimus oral rinse. Credit: MAYA LAB / Shutterstock.

Lipella Pharmaceuticals has dosed two subjects in its Phase IIa OLP clinical trial of LP-310, a potential treatment for oral lichen planus (OLP).

The multi-centre, dose-ranging study will enrol adult subjects with symptomatic OLP, a condition for which there are currently no Food and Drug Administration (FDA)-approved therapies.

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The trial aims to evaluate the efficacy and safety of LP-310, a new liposomal-tacrolimus oral rinse.

This investigational therapy is based on Lipella’s lead candidate LP-10, which is also under evaluation for haemorrhagic cystitis.

The study’s successful initiation is a crucial milestone for the six million Americans affected by OLP.

It is expected to conclude by mid-2025, with Lipella projecting to report top-line data by the end of 2024.

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Lipella focuses on reformulating active agents in generic drugs for new therapeutic applications, particularly targeting diseases with significant unmet medical needs.

Lipella chief medical officer Dr Michael Chancellor said: “Oral lichen planus poses significant challenges, including severe pain, risk of infections, scarring and potential malignant transformation, and the psychological burden on patients further exacerbates the condition. Current treatments are largely palliative.

“Our goal with LP-310 is to address the underlying mechanisms of OLP, aiming for substantial symptom relief and reduced risk of complications, and to deliver the first approved drug treatment for Oral Lichen Planus to this underserved patient population.”

OLP, a debilitating condition, is characterised by oral mucosal lesions and is said to affect millions of individuals globally.

Existing therapeutic options for this condition are limited and it also presents challenges in terms of management and treatment.