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
Lipella製藥公司已完成其LP-310口腔澤瀉劑在口腔白斑症II期A試驗中的第一組給藥，預計年末將發佈頂線數據，並計劃於2025年中期完成試驗。
- 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.
- 在第一個隊列中，八名參與者接受了0.25 mg LP-310 劑量，初步結果令人鼓舞。未報告與產品相關的嚴重不良事件。藥代動力學數據表明，所有患者的全血他克莫司水平要麼檢測不到，要麼微乎其微，這突顯了 LP-310 在最大限度地減少全身暴露的同時提供局部治療效果的潛力。此外，所有患者都耐受 LP-310，沒有明顯的不良反應。
- 在成功對第一劑隊列進行內部安全評估之後，該試驗已獲准進入下一階段的試驗，該階段將評估更高劑量的 0.5 mg LP-310。
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