LIPO Lipella Pharmaceuticals Inc

Lipella Pharmaceuticals Inc. (Nasdaq: LIPO), a clinical-stage biotechnology company dedicated to addressing serious diseases with significant unmet needs, today announced the publication of a peer-reviewed paper in CUREUS. Titled “Rationale for the Use of Topical Calcineurin Inhibitors in the Management of Oral Lichen Planus and Mucosal Inflammatory Diseases,” the paper focuses on non-steroid treatments for oral lichen planus (OLP), particularly topical calcineurin inhibitors (TCIs) such as tacrolimus. TCIs are non-steroidal medications used to treat inflammatory and autoimmune conditions by targeting the enzyme calcineurin, critical for T-cell activation and cytokine production. The publication also explores advanced drug delivery systems designed to address the challenges of treating chronic inflammatory conditions like OLP.

The paper emphasizes the potential of Lipella’s investigational therapy, LP-310, a novel oral rinse formulation of LP-10 (tacrolimus) specifically designed to provide localized therapeutic effects for OLP while minimizing systemic exposure. LP-310 is currently being evaluated in a Phase 2a multicenter clinical trial focused on safety, tolerability, and efficacy in adult patients with symptomatic OLP.

Dr. Michael Chancellor, Lipella’s Chief Medical Officer and author of the paper, commented, “Oral lichen planus is a chronic inflammatory condition that significantly impacts patients' quality of life. Traditional therapies, primarily topical corticosteroids, often lead to undesirable side effects with long-term use. Our research emphasizes the promise of TCIs, such as tacrolimus, as effective alternatives that may offer a steroid-sparing approach. This peer-reviewed paper represents an important next step in advancing a potential breakthrough treatment option for OLP, aiming to address the unmet needs of patients with this challenging condition.”

The publication details the underlying mechanisms of OLP, the role of TCIs in treatment, and emerging therapies such as topical liposomal formulation of tacrolimus designed to optimize local drug delivery while reducing systemic exposure.

About Oral Lichen Planus (OLP)

Oral Lichen Planus (OLP) is a chronic inflammatory condition that affects the mucous membranes inside the mouth, which can cause pain and make eating, drinking and even speaking uncomfortable. Characterized by symptoms such as burning pain, white patches, swollen tissue and open sores, OLP impacts approximately 6 million Americans and currently has no FDA-approved therapies.

About LP-310

LP-310 is an innovative oral rinse formulation of LP-10 (tacrolimus), developed to address oral lichen planus. Designed to provide localized therapeutic effects while minimizing systemic exposure, LP-310 offers a promising new approach to managing this painful and often debilitating condition.

A Phase 2a multicenter, dose-ranging clinical trial is currently underway to evaluate the safety, tolerability and efficacy of LP-310 in adult participants with symptomatic OLP. The trial includes three dose levels (0.25 mg, 0.5 mg and 1.0 mg of tacrolimus) and is being conducted across seven active U.S. sites, which are now recruiting participants. Top-line data is anticipated by the end of 2024, with the trial expected to conclude by mid-2025.

For more information about the study or to participate, visit https://lipella.com/oral-lichen-planus-treatment/ or https://clinicaltrials.gov/study/NCT06233591.

About Lipella Pharmaceuticals Inc.Lipella Pharmaceuticals 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. Additionally, Lipella maintains a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella completed its initial public offering in December 2022.

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CONTACTJonathan KaufmanChief Executive OfficerLipella Pharmaceuticals Inc. Info@Lipella.com 1-412-894-1853

PCG AdvisoryJeff Ramsonjramson@pcgadvisory.com