Lipella Pharmaceuticals Inc., (Nasdaq: LIPO) ("Lipella," "our,"
"us" or the "Company"), a pioneering, clinical-stage pharmaceutical
company, celebrates its first anniversary as a publicly traded
entity. Based in Pittsburgh, PA, the Company has made substantial
strides over the past year, achieving critical milestones and
advancing its pipeline with three clinical indications and two
orphan drug designations granted.
A highlight of the year includes the successful
completion of a Type C meeting with the U.S. Food and Drug
Administration (FDA) focused on the clinical program for LP-10,
Lipella's leading drug candidate for the treatment of hemorrhagic
cystitis (HC). Jonathan Kaufman, CEO of Lipella, expressed his
satisfaction with the meeting's outcome, noting, “The FDA's
feedback from our recent Type C meeting gives us a clear path
forward into 2024. Our planned Phase-2b trial for LP-10 will
involve 36 subjects in a double-blind, placebo-controlled study,
focusing on the treatment's impact on gross hematuria."
Further bolstering its portfolio, Lipella has
secured FDA approval for its Investigational New Drug (IND)
application for a Phase 2a multicenter trial of an oral rinse
formulation of LP-310, targeting Oral Lichen Planus (OLP). With
central Institutional Review Board (IRB) approval in hand, the
Company is in the process of selecting study sites for this
trial.
Additionally, Lipella's LP-310 has been granted
orphan drug designation for the treatment of oral graft-versus-host
disease (GVHD) with tacrolimus. The Company is poised to submit a
Phase 2a IND for this indication in the first quarter of 2024.
Reflecting on the Company's journey, Dr. Michael
Chancellor, Lipella’s Chief Medical Officer, remarked, “Our first
year as a public company, especially during challenging market
conditions, has been remarkable. Heading into 2024, we are
enthusiastic about advancing our assets through clinical trials,
bolstered by two orphan designations.”
As Lipella Pharmaceuticals steps into another
year of innovation and growth, it remains committed to developing
groundbreaking treatments that address critical healthcare
needs.
About LP-10 and LP-310
LP-10 is a liposomal tacrolimus formulation for
intravesical administration to treat hemorrhagic cystitis (HC).
LP-10 has been evaluated in a multi-center Phase 2a dose escalation
trial of 13 subjects with moderate to severe refractory HC.
Positive top line results demonstrated safety and efficacy, short
duration of systemic uptake of LP-10, and a dose response including
decreased hematuria, decreased cystoscopic bleeding and ulceration
sites, and improved urinary symptoms in patients. Lipella has been
granted Orphan Disease Designation by the FDA for LP-10 in the
treatment of moderate to severe hemorrhagic cystitis. LP-310
liposomal tacrolimus is a proprietary oral rinse formulation of
Lipella’s lead drug candidate, LP-10, for the indications of OLP
and oral GVHD. Lipella has been granted orphan drug designation by
the FDA for LP-310 in the treatment of GVHD.
About Hemorrhagic Cystitis
Hemorrhagic cystitis (HC), a severe yet rare
condition often triggered by pelvic radiation therapy and specific
chemotherapies, is characterized by gross hematuria and currently
lacks approved drug treatment. Lipella's LP-10 stands at the
forefront of addressing this unmet medical need.
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
approximately 6-7 million Americans. There is no approved
pharmacotherapy and most currently available treatments are
palliative.
About Graft-versus-Host
Disease
Graft-Versus-Host Disease (GVHD) occurs when
donor bone marrow or stem cells attack the recipient following a
treatment for leukemia, lymphoma, and other hematological cancers.
Oral manifestation of GVHD is frequently involved and is a rare and
serious disease. Lipella has been granted orphan disease
designation for LP-310 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 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, clinical trials,
regulatory approvals, 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, market and other conditions, 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, risks related to the effective application of the use
of proceeds from the private placement, general capital market
risks, 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.com 1-412-894-1853
Jeff RamsonPCG
Advisoryjramson@pcgadvisory.com
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