Lipella Pharmaceuticals Abstract on Oral Lichen Planus Treatment Accepted for Podium Presentation at 2025 AAOM/EAOM International Meeting Conference on “Global Transformation in Oral Medicine”
Lipella Pharmaceuticals (Nasdaq: LIPO) announced that its abstract on LP-10 for treating Oral Lichen Planus (OLP) will be presented at the 2025 joint international meeting of AAOM and EAOM in Las Vegas, May 14-17. The presentation, titled 'Liposomal Tacrolimus (LP-10) Oral Rinse for the Treatment of Oral Lichen Planus: Topline Analysis of a Phase 2a Multicenter Dose-Ranging Trial,' will be delivered by Dr. Alessandro Villa of Miami Cancer Institute.
The study evaluates LP-10, a liposomal formulation of tacrolimus, in patients with symptomatic OLP. Topline results demonstrate clinically meaningful improvements after four weeks of treatment, with statistically significant improvements across clinical measures and visible reductions in inflammation. The oral rinse showed good tolerability and resolution of ulcerative lesions in some patients. Final topline results from the fully enrolled trial are expected in Q2 2025.
Lipella Pharmaceuticals (Nasdaq: LIPO) ha annunciato che il suo abstract su LP-10 per il trattamento del Lichen Planus Orale (LPO) sarà presentato al congresso internazionale congiunto AAOM e EAOM 2025 a Las Vegas, dal 14 al 17 maggio. La presentazione, intitolata 'Risciacquo orale con Tacrolimus liposomiale (LP-10) per il trattamento del Lichen Planus Orale: analisi preliminare di uno studio multicentrico di fase 2a a dosi variabili,' sarà tenuta dal Dr. Alessandro Villa del Miami Cancer Institute.
Lo studio valuta LP-10, una formulazione liposomiale di tacrolimus, in pazienti con LPO sintomatico. I risultati preliminari mostrano miglioramenti clinicamente significativi dopo quattro settimane di trattamento, con miglioramenti statisticamente rilevanti in tutte le misure cliniche e una riduzione visibile dell’infiammazione. Il risciacquo orale ha mostrato buona tollerabilità e la risoluzione delle lesioni ulcerative in alcuni pazienti. I risultati finali completi dello studio, ormai completamente arruolato, sono attesi nel secondo trimestre del 2025.
Lipella Pharmaceuticals (Nasdaq: LIPO) anunció que su resumen sobre LP-10 para el tratamiento del Líquen Plano Oral (LPO) será presentado en la reunión internacional conjunta de AAOM y EAOM 2025 en Las Vegas, del 14 al 17 de mayo. La presentación, titulada 'Enjuague bucal con Tacrolimus liposomal (LP-10) para el tratamiento del Líquen Plano Oral: análisis preliminar de un ensayo multicéntrico de fase 2a con dosis variables,' será impartida por el Dr. Alessandro Villa del Miami Cancer Institute.
El estudio evalúa LP-10, una formulación liposomal de tacrolimus, en pacientes con LPO sintomático. Los resultados preliminares muestran mejoras clínicamente significativas tras cuatro semanas de tratamiento, con mejoras estadísticamente significativas en todas las medidas clínicas y reducción visible de la inflamación. El enjuague bucal mostró buena tolerabilidad y resolución de lesiones ulcerativas en algunos pacientes. Se esperan los resultados finales completos del ensayo, ya totalmente reclutado, para el segundo trimestre de 2025.
Lipella Pharmaceuticals(나스닥: LIPO)는 구강 편평 태선(Oral Lichen Planus, OLP) 치료를 위한 LP-10에 관한 초록이 2025년 5월 14일부터 17일까지 라스베이거스에서 열리는 AAOM과 EAOM 공동 국제회의에서 발표될 예정임을 알렸습니다. '구강 편평 태선 치료를 위한 리포좀 타크로리무스(LP-10) 구강 세척제: 2a상 다기관 용량 탐색 시험의 주요 결과 분석'이라는 제목의 발표는 마이애미 암 연구소의 알레산드로 빌라 박사가 진행할 예정입니다.
본 연구는 증상이 있는 OLP 환자들을 대상으로 타크로리무스의 리포좀 제형인 LP-10을 평가합니다. 주요 결과는 4주간 치료 후 임상적으로 의미 있는 개선을 보여주며, 임상 지표 전반에서 통계적으로 유의한 개선과 염증의 눈에 띄는 감소를 나타냅니다. 구강 세척제는 내약성이 우수했으며 일부 환자에서는 궤양 병변이 해소되었습니다. 완전 등록된 임상시험의 최종 주요 결과는 2025년 2분기에 발표될 예정입니다.
Lipella Pharmaceuticals (Nasdaq : LIPO) a annoncé que son résumé sur LP-10 pour le traitement du Lichen Plan Buccal (LPB) sera présenté lors de la réunion internationale conjointe AAOM et EAOM 2025 à Las Vegas, du 14 au 17 mai. La présentation, intitulée « Bain de bouche au Tacrolimus liposomal (LP-10) pour le traitement du Lichen Plan Buccal : analyse préliminaire d’un essai multicentrique de phase 2a à doses variables », sera réalisée par le Dr Alessandro Villa du Miami Cancer Institute.
L’étude évalue LP-10, une formulation liposomale de tacrolimus, chez des patients atteints de LPB symptomatique. Les résultats préliminaires montrent des améliorations cliniquement significatives après quatre semaines de traitement, avec des améliorations statistiquement significatives sur l’ensemble des mesures cliniques et une réduction visible de l’inflammation. Le bain de bouche a montré une bonne tolérance et une résolution des lésions ulcéreuses chez certains patients. Les résultats finaux complets de l’essai, désormais entièrement recruté, sont attendus au deuxième trimestre 2025.
Lipella Pharmaceuticals (Nasdaq: LIPO) gab bekannt, dass sein Abstract zu LP-10 zur Behandlung des Oralen Lichen Planus (OLP) auf dem gemeinsamen internationalen Treffen der AAOM und EAOM 2025 in Las Vegas vom 14. bis 17. Mai vorgestellt wird. Die Präsentation mit dem Titel „Liposomales Tacrolimus (LP-10) Mundspülung zur Behandlung des Oralen Lichen Planus: Topline-Analyse einer multizentrischen Phase-2a-Dosisfindungsstudie“ wird von Dr. Alessandro Villa vom Miami Cancer Institute gehalten.
Die Studie bewertet LP-10, eine liposomale Formulierung von Tacrolimus, bei Patienten mit symptomatischem OLP. Die Topline-Ergebnisse zeigen klinisch bedeutsame Verbesserungen nach vierwöchiger Behandlung, mit statistisch signifikanten Verbesserungen in allen klinischen Parametern und sichtbaren Entzündungsrückgängen. Die Mundspülung zeigte eine gute Verträglichkeit und bei einigen Patienten eine Abheilung der ulzerativen Läsionen. Die endgültigen Topline-Ergebnisse der vollständig eingeschriebenen Studie werden im zweiten Quartal 2025 erwartet.
- Phase 2a trial showed statistically significant clinical improvements
- Good tolerability profile demonstrated in clinical trials
- Visible reduction in inflammation and resolution of ulcerative lesions observed
- Targeting an indication with no FDA-approved treatments
- Effects return toward baseline post-dosing, indicating temporary relief
- Still in early clinical development phase (Phase 2a)
Insights
Lipella's Phase 2a results show statistically significant improvements in Oral Lichen Planus patients with their LP-10 drug candidate - meaningful progress for an unmet medical need.
The Phase 2a clinical data for Lipella's LP-10 represents a significant milestone in developing a potential treatment for Oral Lichen Planus (OLP), a chronic inflammatory condition causing painful oral lesions and ulcerations. The statistically significant improvements observed across clinical measures, including visible reductions in inflammation and resolution of ulcerative lesions in some patients, provide compelling evidence of therapeutic potential.
What's particularly noteworthy from a pharmaceutical development perspective is the formulation approach. LP-10 utilizes a liposomal delivery system for tacrolimus, which likely enhances local drug delivery while potentially minimizing systemic absorption. The observed pattern of improvement during treatment followed by return toward baseline post-dosing scientifically validates the product's localized mechanism of action rather than suggesting treatment failure.
The acceptance for podium presentation (versus a poster) at the joint AAOM/EAOM meeting indicates peer recognition of the data's significance within the oral medicine community. Having Dr. Alessandro Villa from Miami Cancer Institute present adds further credibility to these findings.
From a clinical development standpoint, these topline results from a dose-ranging study will inform optimal dosing for future trials. The complete topline results expected in Q2 2025 will provide a more comprehensive understanding of the drug's efficacy and safety profile.
This advancement is particularly meaningful because OLP currently has no FDA-approved treatments, representing a significant unmet medical need. For a company focused on developing therapies for underserved conditions, demonstrating clinical efficacy in a Phase 2a trial represents material progress toward potentially addressing this treatment gap.
Joint meeting to be held in Las Vegas, May 14-17
Presentation will be delivered by Dr. Alessandro Villa of Miami Cancer Institute
Topline study results demonstrate clinically meaningful improvements in OLP
Visible lesion resolution during treatment; return toward baseline post-dosing supports localized activity
PITTSBURGH, April 23, 2025 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) ("Lipella," "we," "our," or the "Company"), a clinical-stage biotechnology company focused on developing therapies for diseases with significant unmet needs, today announced that its abstract on LP-10 for the treatment of Oral Lichen Planus (OLP) has been accepted for podium presentation at the 2025 joint international meeting of the American Academy of Oral Medicine (AAOM) and European Association of Oral Medicine (EAOM). The meeting will take place May 14–17 in Las Vegas. The presentation will be delivered by Dr. Alessandro Villa, Chief of Oral Medicine, Oral Oncology and Dentistry, and Professor at Herbert Wertheim College of Medicine, Miami Cancer Institute, on May 15.
The abstract, titled "Liposomal Tacrolimus (LP-10) Oral Rinse for the Treatment of Oral Lichen Planus: Topline Analysis of a Phase 2a Multicenter Dose-Ranging Trial," presents data from an ongoing trial evaluating LP-10, a liposomal formulation of tacrolimus, in patients with symptomatic OLP—a chronic inflammatory condition of the oral mucosa that can cause pain, white patches, swelling, and ulcerations. The oral rinse has demonstrated good tolerability and produced clinically meaningful improvements.
“As the global oral medicine community gathers this spring, we’re proud to present promising new data toward the goal of providing a safe and effective treatment for Oral Lichen Planus,” said Jonathan Kaufman, CEO and co-founder of Lipella. “Our topline results show significant improvement after just four weeks of treatment. This is a meaningful step forward for a patient population in need of recognition, support, and therapeutic options. We look forward to sharing final topline results from the fully enrolled trial, which are expected in the second quarter of 2025.”
“We observed statistically significant improvements across clinical measures, along with visible reductions in inflammation and resolution of ulcerative lesions in some patients,” said Dr. Michael Chancellor, Chief Medical Officer and Co-Founder of Lipella. “These effects were most evident at the end of the treatment period, supporting the clinical relevance of LP-10’s localized activity. Taken together, the data highlight LP-10’s potential as a non-steroidal therapeutic option for a chronic condition with no FDA-approved treatments.”
About the Study
The Oral Lichen Planus Phase 2a trial is a multicenter, dose-ranging study evaluating the safety, tolerability, and efficacy of LP-10 oral rinse in adults (18 years and older) with symptomatic OLP. Three dose levels of tacrolimus—0.25 mg, 0.5 mg, and 1.0 mg—are being assessed. According to Lipella’s Chief Medical Officer Dr. Michael Chancellor, topline findings from the 0.5 mg cohort demonstrated statistically significant and clinically meaningful improvement (p < 0.05) at the primary endpoint, with all outcome measures showing significance at Week 4. A gradual decline in effect was observed by Week 6, two weeks after treatment ended. Investigators also noted visible improvement in oral lesions, including resolution of ulcerations in some patients. A gradual decline in effect was observed by Week 6, two weeks after treatment ended, suggesting strong on-treatment activity with a return toward baseline once dosing ceased.
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:
Jonathan Kaufman
Chief Executive Officer
Lipella Pharmaceuticals Inc.
Info@Lipella.com
1-412-894-1853
PCG Advisory
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jramson@pcgadvisory.com
FAQ
What are the key findings of Lipella Pharmaceuticals' (LIPO) Phase 2a trial for LP-10 in OLP treatment?
When will Lipella Pharmaceuticals (LIPO) release the final topline results for their LP-10 OLP treatment?
What is LP-10 and how does it treat Oral Lichen Planus?
Where and when will Lipella Pharmaceuticals (LIPO) present their LP-10 clinical data?
