Lipella Pharmaceuticals Inc., a biopharmaceutical company dedicated to pioneering treatments for serious ailments with significant unmet clinical needs, announced the conclusion of dosing for the initial cohort in its phase 2a multi-site clinical study of LP-310. LP-310 is a liposomal-tacrolimus oral rinse being tested for oral lichen planus (OLP) therapy.
In this initial group, eight subjects were administered a 0.25 mg dose of LP-310, showing encouraging early outcomes. There were no severe side effects linked to the product. The pharmacokinetic data revealed that all participants exhibited either undetectable or very low whole blood tacrolimus levels, underscoring LP-310’s capability to provide localized therapeutic benefits while reducing systemic exposure. Furthermore, all participants comfortably tolerated LP-310 without experiencing significant adverse effects.
Janet Okonski, in charge of clinical operations at Lipella Pharmaceuticals, commented on feedback from the study locations, “The tolerability in this first group is a promising sign. Oral lichen planus significantly undermines patient quality of life, necessitating an effective treatment with good tolerance. It’s heartening to witness this degree of response at such an early stage.”
Following a favorable internal safety review of the initial dosage group, the trial has received the go-ahead to proceed to the subsequent phase, which will investigate a higher 0.5 mg dose of LP-310.
“We are pleased with this milestone and appreciate the dedication and effort of our study staff and investigators,” expressed Dr. Michael Chancellor, Lipella Pharmaceuticals’ chief medical officer. “We remain devoted to providing a safe and effective solution for oral lichen planus patients as we expand to additional sites and commence enrollment for the next cohort. Our progress thus far is promising, and we aim to deliver key data by year-end and complete the trial by mid-2025.”
Oral lichen planus (OLP) is a persistent inflammatory disorder affecting the oral mucous membranes, leading to discomfort during eating, drinking, and speaking. Symptoms include burning sensation, white patches, swollen areas, and open ulcers, affecting about 6 million Americans without any FDA-approved treatments as yet.
This clinical trial on oral lichen planus is a multicenter, dose-varied study involving adult participants (18 years and older) displaying OLP symptoms. It aims to assess LP-310’s safety, tolerability, and efficacy at 0.25 mg, 0.5 mg, and 1.0 mg tacrolimus doses. Currently, seven sites across the US are open and actively recruiting individuals for this trial.
The study is expected to wrap up by mid-2025, with initial top-line data projected by the end of 2024. Early findings suggest LP-310 could emerge as a groundbreaking treatment for OLP, a condition that severely diminishes patients’ life quality.
Lipella Pharmaceuticals is a forward-thinking biotech entity focusing on reformulating active substances found in existing generic pharmaceuticals to develop innovative applications.