- In this first cohort, eight participants received a dose of 0.25 mg LP-310, with promising initial results. No product-related serious adverse events were reported. Pharmacokinetic data demonstrated that whole blood tacrolimus levels in all patients were either undetectable or minimal, highlighting LP-310's potential to deliver localized therapeutic effects while minimizing systemic exposure. Additionally, all patients tolerated LP-310 without significant adverse reactions.
- Following a successful internal safety evaluation of the first dose cohort, the trial has received approval to advance to the next stage of the trial, which will evaluate a higher dose of 0.5 mg of LP-310.
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Lipella Pharmaceuticals Has Completed Dosing For The First Cohort In Its Phase 2A Trial Of LP-310, A Liposomal-tacrolimus Oral Rinse Being Developed For Oral Lichen Planus, Topline Data Is Expected By Year-end And Complete The Trial By Mid-2025
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