Lipella Pharmaceuticals Announces Publication in CUREUS on Non-Steroid Treatment of Oral Lichen Planus
Lipella Pharmaceuticals (Nasdaq: LIPO) announced the publication of a peer-reviewed paper in CUREUS focusing on non-steroid treatments for oral lichen planus (OLP), particularly topical calcineurin inhibitors (TCIs). The paper discusses the company's investigational therapy LP-310, a novel oral rinse formulation of LP-10 (tacrolimus) designed for localized therapeutic effects while minimizing systemic exposure. LP-310 is currently in a Phase 2a multicenter clinical trial evaluating safety, tolerability, and efficacy in adult OLP patients. The publication explores TCIs as alternatives to traditional corticosteroid treatments, aiming to reduce undesirable side effects associated with long-term steroid use.
Lipella Pharmaceuticals (Nasdaq: LIPO) ha annunciato la pubblicazione di un articolo sottoposto a revisione paritaria su CUREUS, incentrato sui trattamenti non steroidei per il lichen planus orale (LPO), in particolare sugli inibitori della calcineurina topici (ICT). L'articolo discute la terapia in fase di studio LP-310, una formulazione innovativa di sciacquo orale di LP-10 (tacrolimus), progettata per effetti terapeutici localizzati riducendo al minimo l'esposizione sistemica. Attualmente, LP-310 è in una sperimentazione clinica multicentrica di Fase 2a che valuta la sicurezza, la tollerabilità e l'efficacia nei pazienti adulti con LPO. La pubblicazione esplora gli ICT come alternative ai trattamenti corticosteroidei tradizionali, mirando a ridurre gli effetti collaterali indesiderati associati all'uso prolungato di steroidi.
Lipella Pharmaceuticals (Nasdaq: LIPO) anunció la publicación de un artículo revisado por pares en CUREUS que se centra en tratamientos no esteroides para el liquen plano oral (LPO), en particular los inhibidores de la calcineurina tópicos (ICT). El artículo discute la terapia en investigación LP-310, una formulación novedosa de enjuague bucal de LP-10 (tacrolimus) diseñada para efectos terapéuticos localizados mientras minimiza la exposición sistémica. LP-310 se encuentra actualmente en un ensayo clínico multicéntrico de Fase 2a que evalúa la seguridad, la tolerabilidad y la eficacia en pacientes adultos con LPO. La publicación explora los ICT como alternativas a los tratamientos corticosteroides tradicionales, con el objetivo de reducir los efectos secundarios indeseables asociados con el uso prolongado de esteroides.
리펠라 제약회사 (Nasdaq: LIPO)는 구강 백반증 (OLP)에 대한 비스테로이드 치료법, 특히 국소 칼시뉴린 억제제 (TCI)에 중점을 둔 CUREUS에 심사된 논문이 발표되었다고 발표했습니다. 이 논문은 국소 치료 효과를 극대화하면서 전신 노출을 최소화하도록 설계된 LP-10 (타크롤리무스)의 새로운 구강 세척 제형인 LP-310에 대한 회사의 연구 치료법을 논의합니다. LP-310은 현재 성인 OLP 환자에서 안전성, 내약성 및 효능을 평가하는 2a 단계 다기관 임상 시험 중에 있습니다. 이 발표는 전통적인 코르티코스테로이드 치료의 대안으로서 TCI를 탐구하며, 장기적으로 스테로이드 사용과 관련된 원하지 않는 부작용을 줄이는 것을 목표로 하고 있습니다.
Lipella Pharmaceuticals (Nasdaq: LIPO) a annoncé la publication d'un article évalué par des pairs dans CUREUS, axé sur des traitements non stéroïdiens pour le lichen planus oral (LPO), notamment les inhibiteurs de la calcineurine topiques (ICT). L'article discute de la thérapie expérimentale LP-310, une nouvelle formulation de bain de bouche de LP-10 (tacrolimus) conçue pour des effets thérapeutiques localisés tout en minimisant l'exposition systémique. LP-310 est actuellement en essai clinique multicentrique de phase 2a visant à évaluer la sécurité, la tolérance et l'efficacité chez des patients adultes atteints de LPO. La publication explore les ICT comme alternatives aux traitements corticostéroïdiens traditionnels, visant à réduire les effets secondaires indésirables associés à l'utilisation prolongée de stéroïdes.
Lipella Pharmaceuticals (Nasdaq: LIPO) hat die Veröffentlichung eines peer-reviewten Artikels in CUREUS angekündigt, der sich auf nicht-steroidale Behandlungen von oralem Lichen planus (OLP) konzentriert, insbesondere auf topische Calcineurininhibitoren (TCIs). Der Artikel diskutiert die Prüftherapie LP-310, eine neuartige Mundspülung auf Basis von LP-10 (Tacrolimus), die für lokale therapeutische Effekte entwickelt wurde und gleichzeitig die systemische Exposition minimiert. LP-310 befindet sich derzeit in einer Phase 2a multizentrischen klinischen Studie, die Sicherheit, Verträglichkeit und Wirksamkeit bei erwachsenen OLP-Patienten bewertet. Die Veröffentlichung untersucht TCIs als Alternativen zu herkömmlichen Kortikosteroidbehandlungen, mit dem Ziel, unerwünschte Nebenwirkungen zu reduzieren, die mit einer langfristigen Steroidanwendung verbunden sind.
- LP-310 is advancing through Phase 2a clinical trials
- Publication in peer-reviewed journal validates scientific approach
- Novel drug delivery system potentially offers improved treatment option
- None.
Insights
Peer-reviewed article highlights potential treatment for OLP with focus on localized drug delivery
PITTSBURGH, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO), a clinical-stage biotechnology company dedicated to addressing serious diseases with significant unmet needs, today announced the publication of a peer-reviewed paper in CUREUS. Titled “Rationale for the Use of Topical Calcineurin Inhibitors in the Management of Oral Lichen Planus and Mucosal Inflammatory Diseases,” the paper focuses on non-steroid treatments for oral lichen planus (OLP), particularly topical calcineurin inhibitors (TCIs) such as tacrolimus. TCIs are non-steroidal medications used to treat inflammatory and autoimmune conditions by targeting the enzyme calcineurin, critical for T-cell activation and cytokine production. The publication also explores advanced drug delivery systems designed to address the challenges of treating chronic inflammatory conditions like OLP.
The paper emphasizes the potential of Lipella’s investigational therapy, LP-310, a novel oral rinse formulation of LP-10 (tacrolimus) specifically designed to provide localized therapeutic effects for OLP while minimizing systemic exposure. LP-310 is currently being evaluated in a Phase 2a multicenter clinical trial focused on safety, tolerability, and efficacy in adult patients with symptomatic OLP.
Dr. Michael Chancellor, Lipella’s Chief Medical Officer and author of the paper, commented, “Oral lichen planus is a chronic inflammatory condition that significantly impacts patients' quality of life. Traditional therapies, primarily topical corticosteroids, often lead to undesirable side effects with long-term use. Our research emphasizes the promise of TCIs, such as tacrolimus, as effective alternatives that may offer a steroid-sparing approach. This peer-reviewed paper represents an important next step in advancing a potential breakthrough treatment option for OLP, aiming to address the unmet needs of patients with this challenging condition.”
The publication details the underlying mechanisms of OLP, the role of TCIs in treatment, and emerging therapies such as topical liposomal formulation of tacrolimus designed to optimize local drug delivery while reducing systemic exposure.
About Oral Lichen Planus (OLP)
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 LP-310
LP-310 is an innovative oral rinse formulation of LP-10 (tacrolimus), developed to address oral lichen planus. Designed to provide localized therapeutic effects while minimizing systemic exposure, LP-310 offers a promising new approach to managing this painful and often debilitating condition.
A Phase 2a multicenter, dose-ranging clinical trial is currently underway to evaluate the safety, tolerability and efficacy of LP-310 in adult participants with symptomatic OLP. The trial includes three dose levels (0.25 mg, 0.5 mg and 1.0 mg of tacrolimus) and is being conducted across seven active U.S. sites, which are now recruiting participants. Top-line data is anticipated by the end of 2024, with the trial expected to conclude by mid-2025.
For more information about the study or to participate, visit https://lipella.com/oral-lichen-planus-treatment/ or https://clinicaltrials.gov/study/NCT06233591.
About Lipella Pharmaceuticals Inc.
Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications. Additionally, Lipella maintains a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella completed its initial public offering in December 2022.
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CONTACT
Jonathan Kaufman
Chief Executive Officer
Lipella Pharmaceuticals Inc.
Info@Lipella.com
1-412-894-1853
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FAQ
What is Lipella Pharmaceuticals' LP-310 being developed for?
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