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
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
力皮拉制药已完成LP-310的2A期试验第一队列的投药，LP-310是一种利培酮口腔溶液，用于口腔扁平苔藓的开发，预计将于年底公布上线数据，并计划于2025年中旬完成试验。
- 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.
- 在这第一队列中，有八名参与者接受了0.25毫克的LP-310剂量，初步结果令人鼓舞。未报告任何与产品相关的严重不良事件。药代动力学数据表明，所有患者的全血长春新碱水平要么不可检测，要么很少，突出了LP-310在最小化全身曝露的同时提供局部治疗效果的潜力。此外，所有患者均能耐受LP-310而无明显不良反应。
- 在第一剂量队列成功通过内部安全评估后，试验已获批准进入下一个试验阶段，该阶段将评估0.5毫克LP-310的较高剂量。