Lipella Pharmaceuticals Initiates Phase 2a Trial for LP-310 in Oral Lichen Planus, Enrolls First Patients

Pittsburgh, July 29, 2024 -- PRISM Mediawire -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced the enrollment of the first patients in its multi-center Phase 2a clinical trial evaluating LP-310 for the treatment of Oral Lichen Planus (OLP). This chronic inflammatory condition, which affects over 6 million Americans, is characterized by mouth mucous membrane inflammation, pain, and ulceration, and lacks FDA-approved treatments.

Lipella's Phase 2a trial is a multi-center, dose-ranging study of LP-310, a proprietary liposomal-tacrolimus oral rinse formulation of the company’s lead candidate LP-10 for hemorrhagic cystitis. The trial has enrolled its first patients across multiple research sites nationwide, spanning from Philadelphia to San Francisco, and is actively screening additional subjects with symptomatic Oral Lichen Planus.

LP-310 is designed to address the underlying causes of OLP, offering a promising alternative to current palliative treatments and delivering local concentration in the oral cavity, aiming to minimize systemic toxicity. The trial is anticipated to conclude by mid-2025, with top-line data expected year-end 2024.

For more information on the clinical trial, please visit: https://lipella.com/lp-310-oral-lichen-planus/. Additionally, news about the trial is being shared on Facebook OLP support groups, and patients are reaching out with questions.

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.

Lipella 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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Dr. Jonathan Kaufman, CEO

Lipella Pharmaceuticals

Info@Lipella.com

1-412-894-1853

Jeff Ramson

PCG Advisory

jramson@pcgadvisory.com

646-863-6893

Source: Lipella Pharmaceuticals Inc.