Lipella Pharmaceuticals' LP-310 clinical stage
asset is formulated for delivering active agents to the oral cavity
for diseases of the mouth including oral lichen planus and oral
graft-versus-host disease
PITTSBURGH, Nov. 10,
2023 /PRNewswire/ -- Lipella Pharmaceuticals
Inc. (Nasdaq: LIPO), a clinical stage pharmaceutical company
addressing serious diseases with significant unmet need based
in Pittsburgh, PA, announced today
that it has been granted "Orphan Drug Designation" from the U.S.
Food and Drug Administration (FDA) for its drug candidate, LP-310,
which has been designed for the treatment of oral Graft-versus-Host
Disease (GvHD).
FDA Grants Orphan Designation for Lipella's
LP-310 Drug Candidate for Oral Graft-versus-Host Disease
LP-310 is Lipella's clinical stage pipeline asset
intended to be indicated for inflammatory diseases of the oral
cavity, including oral lichen planus and oral GvHD.
LP-310 liposomal tacrolimus is a proprietary oral rinse
formulation of Lipella's lead drug candidate, LP-10. Lipella
recently received FDA clearance for a Phase 2a clinical trial to
evaluate LP-310's safety and efficacy in patients with symptomatic
oral lichen planus, which currently has no FDA approved treatment,
and can severely impact a patient's quality of life.
Dr. Jonathan Kaufman, Ph.D.,
Chief Executive Officer of Lipella, said, "We are very pleased to
have received Orphan Drug Designation for LP-310 in oral GvHD. This
designation is an example of the way we build value, pursuing all
available resources that can de-risk and accelerate our clinical
research programs. Our collaborative practice with the FDA is
critical to our ability to increase the value of all of our
clinical assets. We look forward to advancing this drug as a
potential treatment for this painful complication of chronic
GvHD."
Dr. Michael Chancellor, Chief
Medical Officer at Lipella, said, "GvHD occurs when donor immune
cells attack the recipient's body tissues after an allogeneic
tissue or bone marrow transplant. GvHD affects approximately 30,000
Americans and oral GvHD contributes significantly to morbidity in
cancer survivors. Morbidity of oral GvHD encompasses significant
oral pain and discomfort, making it difficult for patients to eat,
drink and speak. In addition, the risk of oral cavity infection,
fibrosis and even oral cancer increases. Oral GvHD affects
patients' quality of life and is a great unmet need in cancer
survivors."
The FDA's "Orphan Drug Designation" program provides orphan
status to drugs and biologics that are intended for the treatment,
prevention or diagnosis of a rare disease or condition that affects
fewer than 200,000 people in the United
States. Orphan Drug Designation qualifies sponsors for
incentives, including tax credits for qualified clinical trials,
exemption from user fees and a potential seven years of market
exclusivity after approval.
Lipella's LP-10 was previously granted Orphan Drug Designation
by the FDA, making LP-310 the second of Lipella's leading product
candidates to receive this designation.
About LP-310
LP-310 liposomal tacrolimus is a proprietary oral rinse
formulation of Lipella's lead drug candidate, LP-10.
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. Acute GvHD
most commonly affects the skin, liver, and the gastrointestinal
tract, while chronic GvHD affects the skin, mouth, eyes, lungs,
stomach, bowel and liver, as well as other organs. Oral lichen
planus can occur as a single manifestation of chronic GvHD.
About Lipella Pharmaceuticals Inc.
Lipella Pharmaceuticals Inc. is a clinical stage pharmaceutical
company with a focus on capital efficient therapeutic development
opportunities, including the proprietary repositioning of generics
for rare, morbid diseases that currently have no adequate
treatments. Additional information is available at
www.lipella.com.
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 Lipella 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.
Contacts
Dr. Jonathan
Kaufman, CEO
Lipella Pharmaceuticals
Info@Lipella.com
1-412-894-1853
Jeff Ramson
PCG Advisory
jramson@pcgadvisory.com
1-917-912-9130
View original content to download
multimedia:https://www.prnewswire.com/news-releases/fda-grants-orphan-designation-for-lipellas-lp-310-drug-candidate-for-oral-graft-versus-host-disease-301984199.html
SOURCE Lipella Pharmaceuticals Inc.