Lipella Pharmaceuticals Reports Encouraging Early Tolerability Results in Phase 2a Trial of LP-310 for Oral Lichen Planus
Lipella Pharmaceuticals (Nasdaq: LIPO) has reported encouraging early tolerability results in its Phase 2a trial of LP-310 for Oral Lichen Planus (OLP). Three participants have completed the four-week treatment with the oral rinse, showing good tolerability and no unpleasant taste. The multi-center study is evaluating the safety, tolerability, and efficacy of LP-310 at various doses.
LP-310 is a proprietary liposomal-tacrolimus formulation targeting the underlying causes of OLP. It aims to provide a more effective alternative to current palliative treatments by delivering concentrated therapeutic effects directly in the oral cavity while minimizing systemic toxicity. Notably, LP-310 is the only topical treatment in development for OLP, a condition with no FDA-approved pharmacotherapies.
The trial is being conducted at five active sites across the U.S. and is expected to conclude by mid-2025, with top-line data anticipated by year-end 2024. These early results suggest LP-310's potential as a breakthrough treatment for OLP, a condition that significantly impacts patients' quality of life.
Lipella Pharmaceuticals (Nasdaq: LIPO) ha riportato risultati preliminari incoraggianti riguardo alla tollerabilità nel suo studio di fase 2a di LP-310 per il Lichen Planus Orale (OLP). Tre partecipanti hanno completato il trattamento di quattro settimane con il risciacquo orale, mostrando una buona tollerabilità e assenza di sapore sgradevole. Lo studio multicentrico sta valutando la sicurezza, la tollerabilità e l'efficacia di LP-310 a varie dosi.
LP-310 è una formulazione proprietaria di tacrolimus liposomiale che mira a trattare le cause sottostanti dell'OLP. L'obiettivo è fornire un'alternativa più efficace rispetto ai trattamenti palliativi attuali, fornendo effetti terapeutici concentrati direttamente nella cavità orale e riducendo al minimo la tossicità sistemica. Notevolmente, LP-310 è il solo trattamento topico attualmente in sviluppo per l'OLP, una condizione per la quale non esistono farmacoterapie approvate dalla FDA.
Lo studio viene condotto presso cinque centri attivi negli Stati Uniti e si prevede che si concluda entro metà del 2025, con risultati preliminari attesi entro la fine del 2024. Questi risultati iniziali suggeriscono il potenziale di LP-310 come trattamento innovativo per l'OLP, una condizione che impatta significativamente la qualità della vita dei pazienti.
Lipella Pharmaceuticals (Nasdaq: LIPO) ha reportado resultados preliminares alentadores sobre la tolerabilidad en su ensayo de fase 2a de LP-310 para el Liquen Plano Oral (OLP). Tres participantes completaron el tratamiento de cuatro semanas con el enjuague bucal, mostrando buena tolerabilidad y sin sabor desagradable. El estudio multicéntrico está evaluando la seguridad, tolerabilidad y eficacia de LP-310 en varias dosis.
LP-310 es una formulación liposomal de tacrolimus patentada que se centra en las causas subyacentes del OLP. Su objetivo es proporcionar una alternativa más efectiva a los tratamientos paliativos actuales al ofrecer efectos terapéuticos concentrados directamente en la cavidad oral mientras se minimiza la toxicidad sistémica. Notablemente, LP-310 es el único tratamiento tópico en desarrollo para el OLP, una condición sin farmacoterapias aprobadas por la FDA.
El ensayo se lleva a cabo en cinco sitios activos en los Estados Unidos y se espera que concluya a mediados de 2025, con datos preliminares anticipados para finales de 2024. Estos resultados iniciales sugieren el potencial de LP-310 como un tratamiento innovador para el OLP, una condición que impacta significativamente la calidad de vida de los pacientes.
리펠라 제약(Lipella Pharmaceuticals, Nasdaq: LIPO)은 구강 라이켄 평면증(OLP)을 위한 LP-310의 2a상 시험에서 초기 내약성 결과가 유망하다고 보고했습니다. 세 명의 참여자가 4주 치료를 완료했습니다 구강 세척제로, 좋은 내약성과 불쾌한 맛이 없음을 보여주었습니다. 이 다기관 연구는 LP-310의 다양한 용량에 대한 안전성, 내약성 및 효능을 평가하고 있습니다.
LP-310은 OLP의 근본 원인을 목표로 하는 독점적 리포솜 타크로리무스 제형입니다. 이 치료제는 전신 독성을 최소화하면서 구강 내에서 집중된 치료 효과를 직접 전달하여 현재의 완화 치료에 보다 효과적인 대안을 제공하는 것을 목표로 하고 있습니다. 특히, LP-310은 OLP에 대해 개발 중인 유일한 국소 치료제이며, FDA 승인 약물이 없습니다.
시험은 미국 전역의 5개 활성 사이트에서 진행되고 있습니다 그리고 2025년 중반에 종료될 것으로 예상되며, 2024년 말에 주요 데이터가 예상됩니다. 이러한 초기 결과는 OLP에 대한 LP-310의 혁신적인 치료 가능성을 시사하며, 이는 환자의 삶의 질에 큰 영향을 미치는 질환입니다.
Lipella Pharmaceuticals (Nasdaq: LIPO) a rapporté des résultats préliminaires encourageants concernant la tolérance lors de son essai de phase 2a sur LP-310 pour le Lichen Planus Oral (OLP). Trois participants ont complété le traitement de quatre semaines avec le rince-bouche, montrant une bonne tolérance et aucun goût désagréable. L'étude multicentrique évalue la sécurité, la tolérance et l'efficacité de LP-310 à diverses doses.
LP-310 est une formulation liposomale de tacrolimus brevetée ciblant les causes sous-jacentes de l'OLP. Son objectif est de fournir une alternative plus efficace aux traitements palliatifs actuels en délivrant des effets thérapeutiques concentrés directement dans la cavité buccale tout en minimisant la toxicité systémique. Notamment, LP-310 est le seul traitement topique en développement pour l'OLP, une condition pour laquelle il n'existe pas de pharmacothérapies approuvées par la FDA.
L'essai est mené dans Cinq sites actifs aux États-Unis et devrait se terminer d'ici mi-2025, les premières données étant attendues d'ici fin 2024. Ces premiers résultats suggèrent le potentiel de LP-310 comme traitement révolutionnaire pour l'OLP, une condition qui impacte significativement la qualité de vie des patients.
Lipella Pharmaceuticals (Nasdaq: LIPO) hat ermutigende erste Verträglichkeitsresultate aus seiner Phase-2a-Studie zu LP-310 für Lichen planus oral (OLP) berichtet. Drei Teilnehmer haben die vierwöchige Behandlung abgeschlossen mit dem Mundspülmittel, das eine gute Verträglichkeit und keinen unangenehmen Geschmack zeigt. Die multizentrische Studie bewertet die Sicherheit, Verträglichkeit und Wirksamkeit von LP-310 in verschiedenen Dosen.
LP-310 ist eine patentierte liposomale Tacrolimus-Formulierung, die sich auf die zugrunde liegenden Ursachen von OLP konzentriert. Ziel ist es, eine effektivere Alternative zu den derzeit verfügbaren palliativen Behandlungen zu bieten, indem konzentrierte therapeutische Wirkungen direkt in die Mundhöhle geliefert und die systemische Toxizität minimiert werden. Bemerkenswert ist, dass LP-310 die einzige in Entwicklung befindliche topische Behandlung für OLP ist, eine Erkrankung, für die es keine von der FDA zugelassenen Pharmakotherapien gibt.
Die Studie wird an fünf aktiven Standorten in den USA durchgeführt und wird voraussichtlich bis Mitte 2025 abgeschlossen sein, mit den ersten Ergebnissen, die bis Ende 2024 erwartet werden. Diese frühen Ergebnisse deuten auf das Potenzial von LP-310 als bahnbrechende Behandlung für OLP hin, eine Erkrankung, die die Lebensqualität der Patienten erheblich beeinträchtigt.
- Early tolerability results for LP-310 in Phase 2a trial are encouraging
- LP-310 showed good tolerability and no unpleasant taste in initial participants
- LP-310 is the only topical treatment in development for Oral Lichen Planus
- Five U.S. sites are active and recruiting for the clinical trial
- Top-line data anticipated by year-end 2024
- None.
Insights
The early tolerability results from Lipella Pharmaceuticals' Phase 2a trial of LP-310 for Oral Lichen Planus (OLP) are promising, albeit preliminary. With three participants completing the four-week treatment, the oral rinse demonstrated good tolerability and no unpleasant taste. These factors are important for patient compliance in OLP treatment.
The significance lies in LP-310's potential to address a significant unmet medical need. Currently, there are no FDA-approved pharmacotherapies for OLP and LP-310 is the only topical treatment in development. If successful, this could represent a first-in-class therapy for a condition that significantly impacts quality of life.
Investors should note that while these early results are encouraging, the sample size is very small. The full trial involves multiple doses (0.25 mg, 0.5 mg and 1.0 mg of tacrolimus) and is expected to conclude by mid-2025, with top-line data anticipated by year-end 2024. This timeline suggests a long runway before potential commercialization, requiring patience from investors.
For Lipella Pharmaceuticals, a micro-cap company with a market capitalization of just
However, investors should exercise caution. Early-stage biotechs are inherently risky and Lipella's small size makes it particularly vulnerable to cash burn. The company will likely need additional funding to complete the Phase 2a trial and potentially move to Phase 3, which could lead to dilution for current shareholders.
The anticipated timeline for top-line data by year-end 2024 provides a near-term catalyst that could drive stock volatility. Positive results could attract partnership interest or funding opportunities, while negative outcomes could severely impact the stock price. Investors should closely monitor cash position, burn rate and any potential capital raising activities in the coming quarters.
PITTSBURGH, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company focused on addressing serious diseases with significant unmet needs, today announced an update on its ongoing multi-center Phase 2a clinical trial evaluating LP-310 for the treatment of Oral Lichen Planus (OLP). The Company reported that three participants have completed the four-week treatment with LP-310, an oral rinse, with encouraging findings: The treatment was well tolerated and had no unpleasant taste.
Dr. Michael Chancellor, Chief Medical Officer of Lipella Pharmaceuticals, commented, "Oral Lichen Planus is a highly disruptive condition that significantly impacts patients' daily lives. Given the severity of symptoms, tolerability is critical. Symptomatic side effects from current treatments often lead to frequent dose interruptions or delays, which can further complicate disease management. The fact that LP-310 has been well tolerated so far, without unpleasant taste, is very encouraging. We look forward to gathering more data on the safety side as we continue this pivotal trial.”
LP-310 is a proprietary liposomal-tacrolimus formulation derived from Lipella’s lead candidate, LP-10, which was initially developed for hemorrhagic cystitis. LP-310 targets the underlying causes of OLP and aims to provide a more effective alternative to the currently available palliative treatments by delivering a concentrated therapeutic effect directly in the oral cavity while minimizing systemic toxicity. Currently, there are no FDA-approved pharmacotherapies for Oral Lichen Planus, and LP-310 is the only topical treatment in development for OLP.
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. Five 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
Lipella 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. For more information, please visit www.lipella.com or LinkedIn
Forward-Looking Statements
This press release includes certain “forward-looking statements.” All statements, other than statements of historical fact, included in this press release regarding, among other things, our strategy, future operations, financial position, prospects, pipeline and opportunities, sources of growth, successful implementation of our proprietary technology, plans and objectives are forward-looking statements. Forward-looking statements can be identified by words such as “may,” “will,” “could,” “continue,” “would,” “should,” “potential,” “target,” “goal,” “anticipates,” “intends,” “plans,” “seeks,” “believes,” “estimates,” “predicts,” “expects,” “projects” and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding future events and financial trends that we believe may affect among other things, our financial condition, results of operations, business strategy, short- and long-term business operations and objectives, and financial needs. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. We caution you, therefore, against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. There are risks, uncertainties and other factors, both known and unknown, that could cause actual results to differ materially from those in the forward-looking statements which include, but are not limited to, regional, national or global political, economic, business, competitive, market and regulatory conditions, and other factors. Any forward-looking statement made by us is based upon the reasonable judgment of our management at the time such statement is made and speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. Nothing contained herein is, or shall be relied upon as, a promise or representation as to the past or future. In addition, the information contained in this press release is as of the date hereof, and the Company has no obligation to update such information, including in the event that such information becomes inaccurate. You should not construe the contents of this press release as legal, tax and financial advisors as to legal and related matters concerning the matters described herein.
CONTACT
Dr. Jonathan Kaufman, CEO
Lipella Pharmaceuticals
Info@Lipella.com
1-412-894-1853
Jeff Ramson
PCG Advisory
jramson@pcgadvisory.com
646-863-6893
FAQ
What are the early results of Lipella Pharmaceuticals' Phase 2a trial for LP-310 (LIPO)?
When is Lipella Pharmaceuticals (LIPO) expecting to release top-line data for the LP-310 trial?
How many sites are currently active for Lipella Pharmaceuticals' (LIPO) Oral Lichen Planus clinical trial?
What makes LP-310 unique in the treatment of Oral Lichen Planus (LIPO)?
