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.
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
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"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
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SOURCE Lipella Pharmaceuticals Inc.