PITTSBURGH, Nov. 21. 2024 (GLOBE NEWSWIRE) — Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (Lipella or the Company), a clinical-stage biotechnology company focused on innovative therapies for serious diseases with unmet need, today announced the completion of dosing for the first cohort in a multi-center Phase 2a clinical trial of LP-310, liposomal-tacrolimus oral rinse developed for the treatment of Oral Lichen Planus (OLP).
In this first cohort, eight participants received a 0.25 mg dose of LP-310, with promising early results. No serious product-related side effects were reported. Pharmacokinetic data showed that whole blood tacrolimus levels in all patients were undetectable or minimal, indicating the potential of LP-310 to provide local therapeutic effects and reduce systemic exposure. In addition, all patients tolerated LP-310 without significant adverse reactions.
Janet Okonski, Director of Clinical Operations at Lipella Pharmaceuticals, noted the feedback from the study site, stating, Tolerability observed in this initial group is a promising indicator. Oral Lichen Planus greatly affects the patient’s quality of life, and effective and well-tolerated treatment is needed. It’s great to see this kind of response at such an early stage.
After a successful internal safety evaluation of the first dose cohort, the trial has been approved to advance to the next phase of the trial, which will evaluate a higher dose of 0.5 mg of LP-310.
We are proud of this milestone and thank the researchers and study staff for their dedication and hard work, said Dr Michael Chancellor, Head medical (TASE:) Officer of Lipella Pharmaceuticals. Our commitment to developing safe and effective therapies for Oral Lichen Planus patients remains steadfast as we activate additional sites and begin enrolling the next dose cohort. Our pace of progress has been promising, and we are on track to deliver peak data by the end of the year and complete testing by mid-2025.
Oral Lichen Planus (OLP) is a chronic inflammatory condition that affects the mucous membranes inside the mouth, which can cause pain and make eating, drinking and even speaking uncomfortable. Characterized by symptoms such as burning pain, white spots, swollen tissue, and open pain, OLP affects approximately 6 million Americans and currently has no FDA-approved therapy.
About Learning
The Oral Lichen Planus Clinical Trial is a dose-ranging multicenter study involving adult male and female subjects (18 years and older) with symptomatic OLP. This study will evaluate the safety, tolerability and efficacy of LP-10 at doses of 0.25 mg, 0.5 mg and 1.0 mg tacrolimus. Seven sites in the US are currently active and recruiting participants for the trial. For more information, visit https://lipella.com/oral-lichen-planus-treatment/ or https://clinicaltrials.gov/study/NCT06233591.
Clinical trials are expected to be completed by mid-2025, with peak data anticipated by the end of 2024. Early results show LP-310’s potential as a breakthrough treatment for OLP, a condition that affects patient quality. alive.
Information about the company Lipella Pharmaceuticals Inc.
Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing new drugs by reformulating active agents in existing generic drugs and optimizing these formulations for new applications. Lipella targets diseases with unmet needs, for which there are currently no approved drug therapies. The company is completing its initial public offering in 2022. Learn more at lipella.com and follow us on X and LinkedIn.
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IGNITION
Dr. Jonathan Kaufman, CEO
Lipella Pharmaceuticals Kab
Info@Lipella.com
1-412-894-1853
Jeff Rumson
PCG Advisory
jramson@pcgadvisory.com
646-863-6893
Source: Lipella Pharmaceuticals Inc.
