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Lipella Pharmaceuticals Announces FDA Clearance of IND for LP-410 for Oral Graft-Versus-Host Disease, Advancing Clinical Pipeline

Clinical testing of LP-410 expected to commence in Q2 2024

Pittsburgh, PA, March 05, 2024 – 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 clinical testing of LP-410 in the treatment of oral Graft-Versus-Host Disease (GVHD).

Lipella’s clinical study, titled, A Multicenter, Dose-Ranging Trial Evaluating the Safety, Tolerability, and Efficacy of LP-410 in Subjects with Symptomatic Oral GVHD, is expected to commence in the second half of 2024.

Dr. Jonathan Kaufman, CEO of Lipella, said, “We are extremely pleased to announce the approval of our IND application, and we look forward to initiating clinical testing in patients in 2024. This is an important milestone for Lipella as we pursue a potential treatment for this patient population.”

Dr. Michael Chancellor, Lipella’s Chief Medical Officer, said, “Oral GVHD is a rare but serious oral mucosal disease that currently has no approved therapy. We believe that Lipella’s proprietary oral rinse formulation of liposomal tacrolimus has the potential to effectively treat oral GVHD, while minimizing systemic toxicity.  The addition of this clinical asset is a significant expansion to our pipeline, which now comprises three IND-approved assets, two of which have been granted Orphan Disease Designation by the FDA. We are enthusiastic about our path forward.”

LP-410 targets the underlying mechanisms of oral GVHD, potentially providing a safe and effective treatment option for affected individuals.  Lipella received FDA Orphan Drug Designation on tacrolimus for treatment of GVHD on November 8, 2023.

About Oral GVHD

Oral GVHD is a rare and serious disease. GVHD is a major cause of morbidity and mortality with chronic GVHD being the leading cause of nonmalignant fatality post Hematopoietic Cell transplantation (HCT). It is a clinical syndrome where donor-derived T-cells attack the patient’s own tissues, in this case, the oral mucosa.  There is currently no FDA approved local drug treatment of oral GVHD. 

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. 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.

CONTACT
Dr. Jonathan Kaufman, CEO
Lipella Pharmaceuticals
Info@Lipella.com
1-412-894-1853

Jeff Ramson
PCG Advisory
jramson@pcgadvisory.com

SOURCE: Lipella Pharmaceuticals Inc.

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