Lipella Pharmaceuticals Doses First Two Patients in Phase 2a Oral Lichen Planus Clinical Trial
2024年8月12日 - 6:00PM
Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella,” “our,”
“us,” “we” or the “Company”), a clinical-stage biotechnology
company addressing serious diseases with significant unmet need,
today announces the dosing of the first two patients with LP-310 in
its Phase 2a clinical trial in Oral Lichen Planus (OLP) patients.
Lipella’s Phase 2a trial is a multicenter, dose-ranging study
involving adult male and female subjects experiencing symptomatic
Oral Lichen Planus, a chronic inflammatory condition that affects
mucous membranes in the mouth and causes burning and pain as well
as white patches, swollen tissue or open sores. OLP affects about 6
million Americans and currently has no FDA-approved therapies.
LP-310 is a novel liposomal-tacrolimus oral rinse based on the
company's lead candidate LP-10, which is also being evaluated for
hemorrhagic cystitis. This study is expected to conclude in
mid-2025. Lipella Pharmaceuticals anticipates reporting top-line
data from the study by the end of 2024.
Dr. Michael Chancellor, Chief Medical Officer of Lipella,
stated, “Oral Lichen Planus poses significant challenges, including
severe pain, risk of infections, scarring and potential malignant
transformation, and the psychological burden on patients further
exacerbates the condition. Current treatments are largely
palliative. Our goal with LP-310 is to address the underlying
mechanisms of OLP, aiming for substantial symptom relief and
reduced risk of complications, and to deliver the first approved
drug treatment for Oral Lichen Planus to this underserved patient
population.”
Dr. Michael Brennan, Chairman of the Department of Oral
Medicine/Oral & Maxillofacial Surgery and principal
investigator at Atrium Health Carolinas Medical Center, added, “The
initiation of this trial is a crucial step towards filling the
substantial gap in effective treatments for Oral Lichen Planus.
There is a clear and pressing need for FDA-approved therapies, and
patients are eager for new options.”
For more information on the clinical trial, please visit:
https://lipella.com/lp-310-oral-lichen-planus/
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.
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includes certain “forward-looking statements.” All statements,
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CONTACTDr. Jonathan Kaufman,
CEOLipella PharmaceuticalsInfo@Lipella.com1-412-894-1853
Jeff RamsonPCG
Advisoryjramson@pcgadvisory.com646-863-6893
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