LP-310 is an oral formulation of Lipella's lead asset LP-10.

PITTSBURGH, Oct. 20, 2023 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (Nasdaq: "LIPO") ("Lipella," "our, "us" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announces that the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for a multi-center, phase-2a, dose-escalation clinical trial to assess the safety and efficacy of LP-310 in patients with symptomatic oral lichen planus (OLP), a highly morbid condition with no effective treatment.

Lipella Logo (PRNewsfoto/Lipella Pharmaceuticals Inc.)

In March 2023, Lipella created a five-member Scientific Advisory Board in Oral Health, made up of a group of highly regarded experts in oral medicine, to focus on the development of LP-310. This team helped craft the clinical strategy and will be involved in the recruitment of high-quality clinical sites.

Dr. Jonathan Kaufman, CEO of Lipella, said, "This FDA approval demonstrates our ability to significantly advance our value proposition by adding a phase-2, clinical-stage asset to our pipeline."

Dr. Michael Chancellor, Lipella's Chief Medical Officer, said, "OLP is a painful oral mucosal disease that currently has no approved therapy. We look forward to the opportunity to develop an effective treatment."

About Oral Lichen Planus

Oral Lichen Planus (OLP) is a chronic, inflammatory, T-cell-mediated, autoimmune oral mucosal disease. It is a painful condition with malignant potential, and complications include infections, scarring, stress and depression. OLP affects between one and four percent of the world's population. Most currently available therapies are palliative rather than curative.

About Lipella Pharmaceuticals
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. 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. For more information, please visit www.lipella.com or LinkedIn.

Forward-Looking Statements
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, 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, 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, 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.

Dr. Jonathan Kaufman, CEO
Lipella Pharmaceuticals

Jeff Ramson
PCG Advisory

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/lipella-pharmaceuticals-announces-fda-clearance-of-ind-for-lp-310-for-oral-lichen-planus-301962718.html

SOURCE Lipella Pharmaceuticals Inc.

Copyright 2023 PR Newswire

Lipella Pharmaceuticals (NASDAQ:LIPO)
Historical Stock Chart
From Mar 2024 to Apr 2024 Click Here for more Lipella Pharmaceuticals Charts.
Lipella Pharmaceuticals (NASDAQ:LIPO)
Historical Stock Chart
From Apr 2023 to Apr 2024 Click Here for more Lipella Pharmaceuticals Charts.