Lipella Pharmaceuticals Announces Completion of First Cohort in Phase 2a Trial of LP-310 for Oral Lichen Planus, Advancing to Next Dose Group
Lipella Pharmaceuticals has completed dosing for the first cohort in its Phase 2a clinical trial of LP-310, a liposomal-tacrolimus oral rinse for Oral Lichen Planus (OLP). Eight participants received a 0.25 mg dose, showing promising initial results with no product-related serious adverse events. Blood tacrolimus levels were minimal or undetectable, indicating localized therapeutic effects. The trial has advanced to testing a higher 0.5 mg dose. The study spans seven U.S. sites, with top-line data expected by year-end 2024 and trial completion by mid-2025. OLP affects approximately 6 million Americans and currently lacks FDA-approved therapies.
Lipella Pharmaceuticals ha completato la somministrazione per la prima coorte del suo trial clinico di fase 2a di LP-310, un collutorio a base di tacrolimus liposomiale per il Lichen Planusorale (OLP). Otto partecipanti hanno ricevuto una dose di 0,25 mg, mostrando risultati iniziali promettenti e nessun grave evento avverso correlato al prodotto. I livelli di tacrolimus nel sangue erano minimi o non rilevabili, indicando effetti terapeutici localizzati. Lo studio è passato a testare una dose più alta di 0,5 mg. La ricerca comprende sette sedi negli Stati Uniti, con dati preliminari attesi entro la fine del 2024 e completamento del trial entro metà del 2025. L'OLP colpisce circa 6 milioni di americani e attualmente non dispone di terapie approvate dalla FDA.
Lipella Pharmaceuticals ha completado la dosificación para la primera cohorte de su ensayo clínico de fase 2a de LP-310, un enjuague bucal de tacrolimus liposomal para el Lichen Plano Oral (OLP). Ocho participantes recibieron una dosis de 0,25 mg, mostrando resultados iniciales prometedores sin eventos adversos graves relacionados con el producto. Los niveles de tacrolimus en sangre eran mínimos o indetectables, lo que indica efectos terapéuticos localizados. El ensayo ha avanzado a probar una dosis más alta de 0,5 mg. El estudio se lleva a cabo en siete sitios de EE. UU., con datos preliminares esperados para finales de 2024 y finalización del ensayo para mediados de 2025. OLP afecta aproximadamente a 6 millones de estadounidenses y actualmente carece de terapias aprobadas por la FDA.
리펠라 제약은 구강 라이켄 플라누스(OLP)를 위한 리포솜 타크롤리무스 구강 세척제인 LP-310의 2a상 임상 시험 첫 번째 그룹에 대한 투약을 완료했습니다. 0.25mg의 용량을 받은 8명의 참가자가 초기 결과를 보였으며, 제품과 관련된 심각한 부작용은 없었습니다. 혈중 타크롤리무스 수치는 최소이거나 감지 불가능하여 국소적인 치료 효과를 나타냈습니다. 시험은 더 높은 0.5mg 용량을 시험하는 단계로 진입했습니다. 연구는 미국 내 7개 장소에서 진행되며, 2024년 연말까지 초기 데이터가 기대되며, 2025년 중반까지 시험이 완료될 예정입니다. OLP는 약 600만 명의 미국인에게 영향을 미치며 현재 FDA 승인 치료제가 없습니다.
Lipella Pharmaceuticals a complété l'administration pour la première cohorte de son essai clinique de phase 2a de LP-310, un rince-bouche à base de tacrolimus liposomal pour le Lichen Planus Oral (OLP). Huit participants ont reçu une dose de 0,25 mg, montrant des résultats initiaux prometteurs sans événements indésirables graves liés au produit. Les niveaux de tacrolimus dans le sang étaient minimes ou indétectables, ce qui indique des effets thérapeutiques localisés. L'essai est passé au test d'une dose plus élevée de 0,5 mg. L'étude se déroule sur sept sites aux États-Unis, avec des données préliminaires attendues d'ici la fin de 2024 et la fin de l'essai prévue pour mi-2025. L'OLP touche environ 6 millions d'Américains et ne dispose actuellement pas de thérapies approuvées par la FDA.
Lipella Pharmaceuticals hat die Dosierung für die erste Kohorte in seiner Phase 2a-Studie zu LP-310, einem liposomalen Tacrolimus-Mundspülung für Oraler Lichen Planus (OLP), abgeschlossen. Acht Teilnehmer erhielten eine Dosis von 0,25 mg und zeigten vielversprechende erste Ergebnisse ohne schwerwiegende, produktbezogene unerwünschte Ereignisse. Die Tacrolimus-Spiegel im Blut waren minimal oder nicht nachweisbar, was auf lokale therapeutische Effekte hinweist. Die Studie hat den Test einer höheren Dosis von 0,5 mg aufgenommen. Die Studie findet an sieben Standorten in den USA statt, wobei die vorläufigen Daten bis Ende 2024 und der Studienabschluss bis Mitte 2025 erwartet werden. OLP betrifft etwa 6 Millionen Amerikaner und hat derzeit keine von der FDA zugelassenen Therapien.
- Successful completion of first cohort with no serious adverse events
- Minimal systemic absorption demonstrated through blood tests
- Trial approved to advance to higher dose phase
- All patients showed good tolerability to treatment
- None.
Insights
The successful completion of the first cohort in LP-310's Phase 2a trial marks a significant milestone with promising safety data. The key findings include:
- No serious adverse events related to the product
- Minimal to undetectable systemic tacrolimus exposure
- Good tolerability profile at 0.25mg dose
The advancement to a higher dose (0.5mg) cohort suggests confidence in the drug's safety profile. With 7 active trial sites and planned completion by mid-2025, the development timeline appears well-structured. The market opportunity is substantial, targeting approximately 6 million Americans with OLP and being first-to-market could provide significant competitive advantage as there are currently no FDA-approved treatments.
For a micro-cap company with a market cap of
PITTSBURGH, Nov. 21, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company focused on innovative therapies for serious diseases with significant unmet needs, today announced the completion of dosing for the first cohort in its multi-center Phase 2a clinical trial of LP-310, a liposomal-tacrolimus oral rinse being developed for the treatment of Oral Lichen Planus (OLP).
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.
Janet Okonski, Director of Clinical Operations at Lipella Pharmaceuticals, noted feedback from the study site, stating, “The tolerability observed in this initial cohort is a promising indicator. Oral Lichen Planus severely affects patient quality of life, and an effective, well-tolerated treatment is desperately needed. It’s encouraging to see this kind of response at an early stage.”
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.
“We are proud of this milestone and are grateful to our investigators and study staff for their dedication and hard work,” said Dr. Michael Chancellor, Chief Medical Officer of Lipella Pharmaceuticals. “Our commitment to developing a safe and effective therapy for Oral Lichen Planus patients remains steadfast as we activate additional sites and begin enrolling the next dose cohort. The pace of our progress has been promising, and we are on track to deliver top-line data by year-end and complete the trial by mid-2025.”
Oral Lichen Planus (OLP) is a chronic inflammatory condition that affects the mucous membranes inside the mouth, which can cause pain and make eating, drinking and even speaking uncomfortable. Characterized by symptoms such as burning pain, white patches, swollen tissue, and open sores, OLP impacts approximately 6 million Americans and currently has no FDA-approved therapies.
About the Study
The Oral Lichen Planus Clinical Trial is a multicenter, dose-ranging study involving adult male and female subjects (18 years and older) with symptomatic OLP. This study will evaluate the safety, tolerability and efficacy of LP-10 at doses of 0.25 mg, 0.5 mg and 1.0 mg of tacrolimus. Seven sites across the U.S. are now active and recruiting participants for the trial. For more information, please visit https://lipella.com/oral-lichen-planus-treatment/ or https://clinicaltrials.gov/study/NCT06233591.
The clinical trial is expected to conclude by mid-2025, with top-line data anticipated by year-end 2024. The early results indicate the potential of LP-310 as a breakthrough treatment for OLP, a condition that severely impacts patients' quality of life.
About Lipella Pharmaceuticals Inc.
Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing new drugs by reformulating active agents in existing generic drugs and optimizing these reformulations for new applications. Lipella targets diseases with significant unmet needs, where no approved drug therapies currently exist. The company completed its initial public offering in 2022. Learn more at lipella.com and follow us on X and LinkedIn.
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CONTACT
Dr. Jonathan Kaufman, CEO
Lipella Pharmaceuticals
Info@Lipella.com
1-412-894-1853
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