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
646.863.6341
View original content to download
multimedia:https://www.prnewswire.com/news-releases/lipella-pharmaceuticals-phase-2a-clinical-study-results-published-in-the-journal-of-urology-and-nephrology-301934615.html
SOURCE Lipella Pharmaceuticals Inc.