Lipella Pharma Doses First Two Patients in Phase 2a Oral Lichen Planus Clinical Trial

Overview

Lipella Pharmaceuticals Inc., a clinical-stage biotechnology company addressing serious diseases with significant unmet need, announces the dosing of the first two patients with LP-310 in its phase 2a clinical trial in Oral Lichen Planus (OLP) patients.

Lipella’s Phase 2a Trial

• Lipella’s phase 2a trial is a multicenter, dose-ranging study involving adult male and female subjects experiencing symptomatic Oral Lichen Planus, a chronic inflammatory condition that affects mucous membranes in the mouth and causes burning and pain as well as white patches, swollen tissue or open sores. 
• OLP affects about 6 million Americans and currently has no FDA-approved therapies.

About LP-310

• LP-310 is a novel liposomal-tacrolimus oral rinse based on the company's lead candidate LP-10, which is also being evaluated for haemorrhagic cystitis. 
• This study is expected to conclude in mid-2025. 
• Lipella Pharmaceuticals anticipates reporting top-line data from the study by the end of 2024.

Words from the CMO: Lipella

Dr. Michael Chancellor, chief medical officer of Lipella, stated, “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.”

From Atrium Health Carolinas Medical Center

Dr. Michael Brennan, chairman of the department of oral medicine/oral & maxillofacial surgery and principal investigator at Atrium Health Carolinas Medical Center, added, “The initiation of this trial is a crucial step towards filling the substantial gap in effective treatments for Oral Lichen Planus. There is a clear and pressing need for FDA-approved therapies, and patients are eager for new options.

About Oral Lichen Planus

• Oral Lichen Planus (OLP) is a serious and debilitating condition characterized by oral mucosal lesions. 
• It affects millions of individuals worldwide and presents significant challenges in terms of management and treatment. 
• Current therapeutic options are limited, underscoring the critical need for innovative approaches like LP-310 in addressing this unmet medical need.

About Lipella

Lipella is a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications.

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