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Lipella Pharmaceuticals has concluded subject enrollment in its multicentre Phase IIa trial of liposomal tacrolimus oral rinse LP-310, which is aimed at treating oral lichen planus (OLP).
The dose-ranging trial has ultimately enrolled subjects across the tacrolimus’ 0.25mg, 0.50mg and 1.0mg dose cohorts at seven trial sites in the US.
It is designed to assess the tolerability, preliminary efficacy and safety of the oral treatment in adults with symptomatic OLP.
The doses in the trial are administered as a two-times-a-day 10ml oral rinse over four weeks.
Main objectives of the trial include evaluating the pharmacokinetics and safety profile of LP-310, with secondary endpoints assessing its influence on inflammation, oral ulceration, and pain through scoring systems reported by patients and measured by investigators.
Lipella Pharmaceuticals chief medical officer and co-founder Dr Michael Chancellor said: “The completion of enrollment in our Phase IIa trial marks an important step in advancing a non-steroidal, locally delivered treatment for oral lichen planus, an underserved condition with no FDA-approved therapies.
“We have already observed encouraging safety and efficacy signals in the first two dose cohorts, including clinically meaningful reductions in pain, ulceration, and inflammation. With the final cohort now fully enrolled, we look forward to reporting topline results in the near term and believe this dataset will be critical in informing next steps for development and broader clinical strategy.”
Lipella noted that topline outcomes from the final cohort, which is receiving the highest dose of 1.0mg, are expected in the second quarter of this year.
With the completion of enrolment phase, Lizella is planning to submit an investigational new drug (IND) application for a Phase IIb trial in late 2025 and also exploring potential regulatory designations, including breakthrough therapy status.
OLP is said to be a T-cell-mediated autoimmune condition leading to painful erosions and ulcerative lesions in the oral mucosa.
"Lipella enrols all subjects in Phase IIa trial targeting oral lichen planus" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
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