Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella,” “our,” “us”
or the “Company”), a clinical-stage biotechnology company
addressing serious diseases with significant unmet need, today
announced the successful completion of its first Site Initiation
Visit (SIV) for the Phase 2a trial evaluating LP-310 in the
treatment of Oral Lichen Planus (OLP). With clearance received from
the central Institutional Review Board (IRB), the Phase 2a trial is
set to commence with site qualifications completed and patient
recruitment underway.
Lipella’s Phase 2a trial is a multicenter, dose-ranging study
involving adult male and female subjects experiencing symptomatic
OLP. Approximately 24 subjects will be enrolled across five study
sites in the United States. LP-310, Lipella's proprietary
liposomal-tacrolimus (LP-10) oral rinse formulation, will be
evaluated for safety, tolerability, and efficacy at doses of 0.25
mg, 0.5 mg, and 1.0 mg of tacrolimus. The trial, registered on
ClinicalTrials.gov (NCT06233591), aims to address the unmet need
for an effective treatment for OLP, a condition that currently
lacks FDA-approved therapies.
Participants in the study will undergo screening, treatment, and
follow-up phases. During the treatment phase, they will use a 10 mL
LP-10 oral rinse for 3 minutes twice a day for 4 weeks, followed by
a single post-treatment visit 2 weeks after the last dose. The
study is anticipated to conclude in mid-2025.
Dr. Jonathan Kaufman, CEO of Lipella, expressed his enthusiasm,
stating, “We are extremely pleased to announce the completion of
the Site Initiation Visit for our Phase 2a trial of LP-310. This
milestone brings us one step closer to providing a potential
treatment for the estimated 6 million Americans affected by OLP, a
condition that causes significant pain and has no approved
therapies.”
Dr. Michael Chancellor, Chief Medical Officer of Lipella,
highlighted the significance of the trial, noting, “OLP presents as
a painful oral mucosal disease with no approved therapy. We are
optimistic that Lipella's proprietary oral rinse formulation of
liposomal tacrolimus offers significant potential in treating OLP
while minimizing systemic toxicity. I eagerly anticipate
collaborating with the principal investigators to ensure a safe and
seamless trial process.”
About Oral Lichen Planus Oral Lichen Planus
(OLP) is a serious and debilitating condition characterized by oral
mucosal lesions. It affects millions of individuals worldwide and
presents significant challenges in terms of management and
treatment. Current therapeutic options are limited, underscoring
the critical need for innovative approaches like LP-310 in
addressing this unmet medical need.
About Lipella PharmaceuticalsLipella 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 StatementsThis 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.
CONTACTDr. Jonathan Kaufman, CEOLipella
PharmaceuticalsInfo@Lipella.com1-412-894-1853
Jeff RamsonPCG Advisoryjramson@pcgadvisory.com
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