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

Lipella Pharmaceuticals Inc. recently 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.

Dr. Jonathan Kaufman, CEO of Lipella Pharmaceuticals, said “We are very pleased with the rapid pace of site activation, and the enrollment of our initial patients marks a pivotal milestone for both the company and the patient community suffering from this debilitating condition. This achievement reinforces our mission to redefine treatment paradigms for Oral Lichen Planus. With LP-310’s innovative approach to targeting disease mechanisms, we are excited about the potential to deliver a transformative therapy, alleviating symptoms and improving patient outcomes significantly.”

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.

Dr. Michael Chancellor, Chief Medical Officer of Lipella, added “We have heard the urgency for new effective OLP therapies from patients, clinicians and advocacy groups. OLP not only induces debilitating physical symptoms but also poses risks of serious complications. LP-310’s potential to mitigate these challenges represents a significant advancement in therapeutic options.”

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, visit www.lipella.com.