Peer-reviewed article highlights potential treatment for OLP with focus on localized drug delivery
PITTSBURGH, Pa., December 03, 2024 - PRISM MediaWire - 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.
“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.”
Dr. Michael Chancellor, Lipella’s Chief Medical Officer and author of the paper
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.
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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This press release includes certain "forward-looking statements." All statements, other than statements of historical fact, included in this press release regarding, among other things, our strategy, future operations, financial position, prospects, clinical trials, regulatory approvals, pipeline and opportunities, sources of growth, successful implementation of our proprietary technology, plans and objectives are forward-looking statements. Forward-looking statements can be identified by words such as "may," "will," "could," "continue," "would," "should," "potential," "target," "goal," "anticipates," "intends," "plans," "seeks," "believes," "estimates," "predicts," "expects," "projects" and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding future events and financial trends that we believe may affect among other things, market and other conditions, our financial condition, results of operations, business strategy, short- and long-term business operations and objectives, and financial needs. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. We caution you, therefore, against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. There are risks, uncertainties and other factors, both known and unknown, that could cause actual results to differ materially from those in the forward-looking statements which include, but are not limited to, risks related to the effective application of the use of proceeds from the private placement, general capital market risks, regional, national or global political, economic, business, competitive, market and regulatory conditions, and other factors. Any forward-looking statement made by us is based upon the reasonable judgment of our management at the time such statement is made and speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. Nothing contained herein is, or shall be relied upon as, a promise or representation as to the past or future. In addition, the information contained in this press release is as of the date hereof, and the Company has no obligation to update such information, including in the event that such information becomes inaccurate. You should not construe the contents of this press release as legal, tax and financial advisors as to legal and related matters concerning the matters described herein.
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Lipella Pharmaceuticals Inc.
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Source: Lipella Pharmaceuticals Inc.