Sales figures expected at the end of 2024
PITTSBURGH, Aug. 12, 2024 (GLOBE NEWSWIRE) — Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella”, “our”, “us”, “we” or the “Company”), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced the dosing of LP-310 to the first two patients in its Phase 2a clinical trial in patients with oral lichen planus (OLP).
Lipella’s Phase 2a trial is a multicenter, dose-finding study in adult male and female subjects who have symptomatic oral lichen planus, a chronic inflammatory disease that affects the mucous membranes in the mouth and causes burning and pain, as well as white patches, swollen tissue, or open sores. OLP affects approximately 6 million Americans and there are currently no FDA-approved therapies.
LP-310 is a novel liposomal tacrolimus mouthwash based on the Company’s lead product candidate LP-10, which is also being investigated for the treatment of hemorrhagic cystitis. This study is expected to be completed in mid-2025. Lipella Pharmaceuticals expects to present topline results from the study by the end of 2024.
Dr. Michael Chancellor, Chief Medical Officer of Lipella, stated, “Oral lichen planus presents significant challenges, including severe pain, risk of infection, scarring and potential malignant transformation, and the psychological burden on patients further exacerbates the condition. Current treatments are largely palliative in nature. Our goal with LP-310 is to address the underlying mechanisms of OLP to achieve significant symptom relief and reduced risk of complications, providing this underserved patient population with the first approved drug treatment for oral lichen planus.”
Dr. Michael Brennan, chair of the Department of Oral Medicine/Oral and Maxillofacial Surgery and principal investigator at Atrium Health Carolinas Medical Center, added, “The initiation of this trial is a critical step toward closing the significant gap in effective treatments for oral lichen planus. There is a clear and urgent need for FDA-approved therapies, and patients are eager for new options.”
For more information about the clinical trial, please visit: https://lipella.com/lp-310-oral-lichen-planus/
About oral lichen planus
Oral lichen planus (OLP) is a serious and debilitating disease characterized by lesions of the oral mucosa. It affects millions of people worldwide and presents significant challenges in terms of management and treatment. Current therapeutic options are limited, highlighting the urgent need for innovative approaches such as LP-310 to address this unmet medical need.
About Lipella Pharmaceuticals
Lipella is a clinical-stage biotechnology company focused on developing new medicines by reformulating the active ingredients of existing generic drugs and optimizing these reformulations for new applications. In addition, Lipella is therapeutically focused on diseases with significant, unaddressed morbidity and mortality for which there is currently no approved drug therapy. Lipella completed its IPO in December 2022. For more information, visit www.lipella.com or LinkedIn.
Forward-looking statements
This press release contains certain “forward-looking statements”. All statements in this press release, other than statements of historical fact, which address, among other things, our strategy, future operations, financial condition, prospects, 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,” “goal,” “anticipate,” “intend,” “plan,” “seek,” “believe,” “estimate,” “predict,” “expect,” “project” 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, our financial condition, results of operations, business strategy, short- and long-term operations and objectives and financing 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 anticipated in the forward-looking statements. We therefore caution you not to rely on these forward-looking statements. They are neither statements of historical fact nor guarantees or representations of future performance. There are risks, uncertainties and other known and unknown factors that may cause actual results to differ materially from those in the forward-looking statements. These include, among others, regional, national or global political, economic, business, competitive, market and regulatory conditions and other factors. Any forward-looking statement we make is based on the reasonable judgment of our management at the time the statement is made and speaks only as of the date the statement is made. From time to time, factors or events may arise that could cause different results, and it is not possible for us to predict all of them. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as required by law. Nothing contained herein is, and should not be relied upon as, a promise or representation of the past or future. In addition, the information contained in this press release is as of the date hereof and the Company undertakes no obligation to update such information, including in the event such information becomes inaccurate. You should not construe the contents of this press release as legal, tax and financial advice on legal and related matters relating to the matters described herein.
CONTACT
Dr. Jonathan Kaufman, CEO
Lipella Pharma
[email protected]
1-412-894-1853
Jeff Ramson
PCG Consulting
[email protected]
646-863-6893
