Lipella Pharmaceuticals Announces FDA Clearance of IND for LP-410 for Oral Graft-Versus-Host Disease, Advancing Clinical Pipeline
06 March 2024 - 12:00AM
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 clinical
testing of LP-410 in the treatment of oral Graft-Versus-Host
Disease (GVHD).
Lipella’s clinical study, titled, A Multicenter,
Dose-Ranging Trial Evaluating the Safety, Tolerability, and
Efficacy of LP-410 in Subjects with Symptomatic Oral GVHD, is
expected to commence in the second half of 2024.
Dr. Jonathan Kaufman, CEO of Lipella, said, “We
are extremely pleased to announce the approval of our IND
application, and we look forward to initiating clinical testing in
patients in 2024. This is an important milestone for Lipella as we
pursue a potential treatment for this patient population.”
Dr. Michael Chancellor, Lipella’s Chief Medical
Officer, said, “Oral GVHD is a rare but serious oral mucosal
disease that currently has no approved therapy. We believe that
Lipella’s proprietary oral rinse formulation of liposomal
tacrolimus has the potential to effectively treat oral GVHD, while
minimizing systemic toxicity. The addition of this clinical asset
is a significant expansion to our pipeline, which now comprises
three IND-approved assets, two of which have been granted Orphan
Disease Designation by the FDA. We are enthusiastic about our path
forward.”
LP-410 targets the underlying mechanisms of oral GVHD,
potentially providing a safe and effective treatment option for
affected individuals. Lipella received FDA Orphan Drug Designation
on tacrolimus for treatment of GVHD on November 8, 2023.
About Oral GVHDOral GVHD is a
rare and serious disease. GVHD is a major cause of morbidity and
mortality with chronic GVHD being the leading cause of nonmalignant
fatality post Hematopoietic Cell transplantation (HCT). It is a
clinical syndrome where donor-derived T-cells attack the patient's
own tissues, in this case, the oral mucosa. There is currently no
FDA approved local drug treatment of oral GVHD.
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
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forward-looking statements relate to the future, they are subject
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caution you, therefore, against relying on any of these
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historical fact nor guarantees or assurances of future performance.
There are risks, uncertainties and other factors, both known and
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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
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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
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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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