| | Article highlights results from successful Phase 2a clinical trial for lead candidate, LP-10 Lipella expects to initiate Phase 2b clinical trial in LP-10 in early 2024 PITTSBURGH, Pa., Sept. 21, 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 results of its successful Phase 2a clinical trial have been the published in the peer-reviewed Journal of Urology and Nephrology. The article, titled “Intravesical liposomal tacrolimus for hemorrhagic cystitis: a phase 2a multicenter dose-escalation study,” highlights the clinically meaningful efficacy and safety profile of Lipella’s lead product candidate, LP-10 as a potential treatment for hemorrhagic cystitis. Jonathan Kaufman, Ph.D., Lipella’s Chief Executive Officer, said, “The peer-reviewed publication of our Phase 2a study results is a milestone achievement for Lipella. It underscores the significance of our clinical program and LP-10’s potential as a first-in-class treatment for the cancer survivor community with hemorrhagic cystitis.” Dr. Michael Chancellor, Chief Medical Officer at Lipella, said, “LP-10 has received Orphan Disease Designation from the US Food and Drug Administration (FDA) for the treatment of hemorrhagic cystitis, a potentially fatal disease with great unmet need and no currently approved drug treatment. We are scheduled to have a Type-C meeting with FDA in Q4 and plan to share details on those discussions shortly thereafter. We currently expect to initiate our Phase 2b clinical trial for LP-10 in January 2024.” Clinical Trial Highlights Lipella’s multi-center, dose-escalation study was led by Dr. Jason Hafron of Michigan Institute of Urology. - 13 patients with moderate to severe refractory hemorrhagic cystitis were treated with up to two courses of LP-10 intravesical bladder instillations.
- Pharmacokinetic analysis demonstrated a very short duration of systemic uptake and symptomatic improvements including:
- decreased hematuria
- decreased cystoscopic bleeding
- a reduced number of ulceration sites, and,
- improved urinary symptoms.
ABOUT HEMORRHAGIC CYSTITIS Hemorrhagic cystitis is a disease with great unmet need and no currently approved drug treatment. Radiation used to treat various cancers can cause chronic, painful urinary inflammation and blood loss, known as radiation hemorrhagic cystitis. Certain chemotherapies can also cause this painful form of urinary bleeding. The blood loss associated with hemorrhagic cystitis can lead to surgery and can be fatal. There are currently no adequate therapies available for the treatment of moderate to severe hemorrhagic cystitis patients. ABOUT LIPELLA PHARMACEUTICALS INC.
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. CONTACT
Dr. Jonathan Kaufman, CEO
Lipella Pharmaceuticals
Info@Lipella.com
1-412-894-1853 Chuck Harbey
PCG Advisory
charbey@pcgadvisory.com
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