Lipella Pharmaceuticals Announces U.S. Patent Allowance for Innovative Liposomal Drug Delivery Platform
Lipella Pharmaceuticals (Nasdaq: LIPO) has received a notice of allowance from the USPTO for its proprietary liposomal drug delivery platform. The patent application, titled 'Delivery of Agents Using Metastable Liposomes,' covers key innovations in Lipella's technology for delivering therapeutic agents via liposome-based vehicles.
This breakthrough enables precise, targeted delivery, improving safety and efficacy across multiple therapeutic areas, including oncology, cancer survivorship, and immunotherapy. The patent provides broad IP protection for Lipella's drug delivery platform, which optimizes delivery to epithelial tissues. It extends market exclusivity for two lead clinical assets currently in Phase 2 trials.
Dr. Michael Chancellor, CMO of Lipella, highlighted the significance of this milestone in advancing therapies for conditions such as hemorrhagic cystitis and oral lichen planus. The company's liposomal drug delivery system offers a safer and more effective means of administering therapeutics like tacrolimus by targeting disease sites directly and minimizing systemic side effects.
Lipella Pharmaceuticals (Nasdaq: LIPO) ha ricevuto un avviso di concessione dall'USPTO per la sua piattaforma proprietaria di somministrazione di farmaci liposomali. La domanda di brevetto, intitolata 'Somministrazione di Agenti Utilizzando Liposomi Metastabili,' copre innovazioni chiave nella tecnologia di Lipella per la somministrazione di agenti terapeutici tramite veicoli basati su liposomi.
Questa scoperta consente una somministrazione precisa e mirata, migliorando la sicurezza e l'efficacia in diverse aree terapeutiche, tra cui oncologia, sopravvivenza al cancro e immunoterapia. Il brevetto fornisce una vasta protezione nella proprietà intellettuale per la piattaforma di somministrazione di farmaci di Lipella, che ottimizza la somministrazione ai tessuti epiteliali. Estende l'esclusività di mercato per due asset clinici principali attualmente in fase 2 di sperimentazione.
Il Dr. Michael Chancellor, CMO di Lipella, ha sottolineato l'importanza di questo traguardo nell'avanzare le terapie per condizioni come cistite emorragica e lichen planus orale. Il sistema di somministrazione di farmaci liposomali dell'azienda offre un mezzo più sicuro ed efficace per somministrare terapeutiche come il tacrolimus, mirando direttamente ai siti di malattia e riducendo al minimo gli effetti collaterali sistemici.
Lipella Pharmaceuticals (Nasdaq: LIPO) ha recibido un aviso de concesión de la USPTO para su plataforma de entrega de fármacos liposomales patentada. La solicitud de patente, titulada 'Entrega de Agentes Usando Liposomas Metastables,' abarca innovaciones clave en la tecnología de Lipella para entregar agentes terapéuticos mediante vehículos basados en liposomas.
Este avance permite una entrega precisa y dirigida, mejorando la seguridad y eficacia en múltiples áreas terapéuticas, incluyendo oncología, supervivencia al cáncer e inmunoterapia. La patente ofrece una amplia protección de propiedad intelectual para la plataforma de entrega de fármacos de Lipella, que optimiza la entrega a los tejidos epiteliales. Extiende la exclusividad de mercado para dos activos clínicos principales que actualmente se encuentran en ensayos de Fase 2.
El Dr. Michael Chancellor, CMO de Lipella, hizo hincapié en la importancia de este hito en el avance de terapias para condiciones como cistitis hemorrágica y líquen plano oral. El sistema de entrega de fármacos liposomales de la compañía ofrece un medio más seguro y efectivo para administrar tratamientos como el tacrolimus, dirigiéndose directamente a los sitios de enfermedad y minimizando los efectos secundarios sistémicos.
리펠라 제약(Lipella Pharmaceuticals, Nasdaq: LIPO)은 자사의 독점적인 리포좀 약물 전달 플랫폼에 대해 USPTO로부터 허가通知를 받았습니다. '메타스테이블 리포좀을 이용한 제제 전달,'라는 제목의 특허 출원은 리펠라의 리포좀 기반 차량을 통해 치료제를 전달하는 기술의 주요 혁신을 다룹니다.
이번 혁신은 정밀하고 표적화된 전달을 가능하게 하여 종양학, 암 생존 및 면역 요법 등 여러 치료 분야에서 안전성과 효능을 개선합니다. 이 특허는 리펠라의 약물 전달 플랫폼에 대한 폭넓은 지적 재산 보호를 제공하며, 상피 조직에 대한 전달을 최적화합니다. 현재 2상 임상 시험 중인 두 개의 주요 자산에 대한 시장 독점권을 연장합니다.
리펠라의 CMO인 마이클 챈슬러 박사는 출혈성 방광염 및 구강 편평태선과 같은 상태에 대한 치료법 발전에서 이 이정표의 중요성을 강조했습니다. 회사의 리포좀 약물 전달 시스템은 질병 부위를 직접 타겟팅하고 전신 부작용을 최소화하여 타크롤리무스와 같은 치료제를 보다 안전하고 효과적으로 관리할 수 있는 방법을 제공합니다.
Lipella Pharmaceuticals (Nasdaq: LIPO) a reçu un avis d'acceptation de l'USPTO pour sa plateforme de livraison de médicaments liposomaux propriétaire. La demande de brevet, intitulée 'Livraison d'Agents Utilisant des Liposomes Métastables,' couvre des innovations clés dans la technologie de Lipella pour la livraison d'agents thérapeutiques par le biais de véhicules à base de liposomes.
Cette avancée permet une livraison précise et ciblée, améliorant la sécurité et l'efficacité dans plusieurs domaines thérapeutiques, y compris l'oncologie, la survie au cancer et l'immunothérapie. Le brevet offre une large protection de propriété intellectuelle pour la plateforme de livraison de médicaments de Lipella, qui optimise la livraison aux tissus épithéliaux. Il prolonge l'exclusivité du marché pour deux actifs cliniques principaux actuellement en essais de Phase 2.
Le Dr. Michael Chancellor, CMO de Lipella, a souligné l'importance de cette étape dans l'avancement des thérapies pour des conditions telles que la cystite hémorragique et le lichen planus oral. Le système de livraison de médicaments liposomaux de l'entreprise offre un moyen plus sûr et plus efficace d'administrer des thérapeutiques comme le tacrolimus en ciblant directement les sites de maladie et en minimisant les effets secondaires systémiques.
Lipella Pharmaceuticals (Nasdaq: LIPO) hat eine Mitteilung über die Genehmigung vom USPTO für seine proprietäre liposomale Arzneimittelabgabetechnologie erhalten. Die Patentanmeldung mit dem Titel 'Abgabe von Wirkstoffen unter Verwendung von metastabilen Liposomen,' umfasst wichtige Innovationen in Lipellas Technologie zur Abgabe therapeutischer Wirkstoffe durch liposombasierte Fahrzeuge.
Dieser Durchbruch ermöglicht eine präzise, gezielte Abgabe, die Sicherheit und Wirksamkeit in mehreren therapeutischen Bereichen, einschließlich Onkologie, Krebsüberleben und Immuntherapie, verbessert. Das Patent bietet einen umfassenden Schutz des geistigen Eigentums für Lipellas Arzneimittelabgabeplattform, die die Abgabe an Epithelgewebe optimiert. Es verlängert die Marktexklusivität für zwei führende klinische Vermögenswerte, die sich derzeit in Phase-2-Studien befinden.
Dr. Michael Chancellor, CMO von Lipella, hob die Bedeutung dieses Meilensteins bei der Weiterentwicklung von Therapien für Erkrankungen wie hämorrhagische Zystitis und orale Lichenplanus hervor. Das liposomale Arzneimittelabgabesystem des Unternehmens bietet eine sicherere und effektivere Methode zur Verabreichung von Therapeutika wie Tacrolimus, indem es direkt auf die Krankheitsstellen abzielt und systemische Nebenwirkungen minimiert.
- Receipt of USPTO notice of allowance for proprietary liposomal drug delivery platform
- Patent provides broad IP protection and extends market exclusivity for two lead clinical assets
- Technology enables precise, targeted delivery, improving safety and efficacy across multiple therapeutic areas
- Strengthens competitive position with patents covering formulations in U.S., Australia, and Canada until 2035
- None.
Insights
This patent allowance significantly strengthens Lipella's intellectual property portfolio and market position. The broad claims covering their metastable liposome delivery platform provide important protection for their technology and extend market exclusivity for lead assets LP-10 and LP-310, currently in Phase 2 trials. This is particularly valuable for a small-cap biotech like Lipella (
The platform's potential to improve safety and efficacy across multiple therapeutic areas, including oncology and immunotherapy, could lead to increased partnering opportunities or licensing deals. The targeted delivery to epithelial tissues addresses a key challenge in drug administration, potentially reducing systemic side effects and improving patient outcomes.
While this news is positive for Lipella's long-term prospects, investors should note that the company is still in clinical stages without approved products. The extended patent protection until 2035 provides a solid runway for development, but commercialization is likely years away. This patent allowance may not have an immediate impact on revenues but significantly enhances the company's value proposition and potential for future success.
Lipella's liposomal drug delivery platform represents a significant advancement in targeted therapeutics. The ability to precisely deliver agents to epithelial tissues while minimizing systemic exposure addresses a critical challenge in drug development, particularly for conditions affecting the bladder, mouth and other mucosal surfaces.
The platform's versatility, covering various therapeutic agents, positions Lipella favorably in multiple high-value markets. For their lead candidates:
- LP-10 for hemorrhagic cystitis could offer a much-needed treatment option for this serious condition, often a complication of cancer therapies.
- LP-310 for oral lichen planus targets an underserved market with effective treatments.
The patent allowance not only protects these assets but also opens doors for potential expansion into other epithelial tissue-related disorders. This could attract partnerships or licensing deals, important for a small biotech to fund further development and potential commercialization.
However, success hinges on clinical trial outcomes. Positive Phase 2 results for LP-10 and LP-310 will be critical in validating the platform's potential and driving Lipella's value proposition.
- Patent application covers key technology innovations for delivering therapeutic agents
- Proprietary technology enables precise delivery to improve safety and efficacy in oncology, cancer survivorship and immunotherapy
- Allowance provides broad IP protection for drug-delivery platform and extends market exclusivity for two lead clinical assets currently in Phase 2 trials
PITTSBURGH, Oct. 15, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO), a clinical-stage biotechnology company focused on developing therapies for serious diseases with unmet medical needs, today announced the receipt of a notice of allowance from the U.S. Patent and Trademark Office (USPTO) for its proprietary liposomal drug delivery platform. The patent application, U.S. Patent No. 17/829,960, titled "Delivery of Agents Using Metastable Liposomes," covers key innovations in Lipella’s platform technology for delivering therapeutic agents via liposome-based vehicles.
The patent allows claims that cover Lipella’s method for using metastable liposomes to deliver a variety of therapeutic agents, including the company’s lead assets, LP-10 and LP-310. This breakthrough technology enables precise, targeted delivery, improving the safety and efficacy of treatments across multiple therapeutic areas, including oncology, cancer survivorship, and immunotherapy.
Dr. Michael Chancellor, Chief Medical Officer of Lipella Pharmaceuticals, commented, "The allowance of this patent is a significant milestone for Lipella as it strengthens our intellectual property portfolio and supports our ongoing efforts to advance therapies for conditions such as hemorrhagic cystitis and oral lichen planus. Our liposomal drug delivery system offers a safer and more effective means of administering therapeutics like tacrolimus by targeting disease sites directly and minimizing the systemic side effects typically associated with these treatments."
This newly allowed patent provides broad intellectual property protection for Lipella’s drug delivery platform, which optimizes delivery to epithelial tissues such as those lining the mouth, bladder, colon, esophagus, vagina, and urethra. It extends market exclusivity and strengthens Lipella’s competitive position, particularly for its two lead clinical assets currently in Phase 2 trials. With additional patents covering the company's formulations in the U.S., Australia, and Canada until 2035, Lipella is poised for further growth and development as it continues to advance its clinical pipeline.
About Lipella’s Lead Clinical Assets: LP-10 and LP-310
- LP-10 is a liposomal formulation of tacrolimus designed for intravesical administration to treat hemorrhagic cystitis (HC), a rare but severe condition characterized by bleeding from the bladder. LP-10 has shown promising safety and efficacy results in a multicenter Phase 2a trial, where it improved urinary symptoms in patients. The FDA has granted Orphan Drug Designation to LP-10 for the treatment of moderate to severe HC, further underscoring its potential to address this critical unmet need. A Phase 2b multicenter placebo-controlled trial is ready to begin.
- LP-310 is an innovative oral rinse formulation of LP-10, designed to treat oral lichen planus (OLP), a chronic autoimmune disease affecting the mucous membranes of the mouth. LP-310 offers a promising new approach to treating OLP, which affects millions of Americans and currently lacks an approved pharmacotherapy. A Phase 2a multicenter trial is underway with anticipated top-line data by year-end and trial completion by mid-2025.
About Hemorrhagic Cystitis (HC)
Hemorrhagic cystitis is a serious condition often resulting from radiation therapy or chemotherapy, marked by severe bleeding in the bladder. With no FDA-approved drug treatments available, LP-10 is positioned to become a breakthrough therapy for patients suffering from this debilitating condition.
About Oral Lichen Planus (OLP)
Oral lichen planus is a chronic autoimmune disease that causes inflammation and lesions in the oral mucosa. It can lead to significant discomfort, scarring, and increased risk of oral cancer. Despite affecting six to seven million people in the U.S., there are no approved treatments, and current therapies offer only symptomatic relief.
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. For more information, please visit www.lipella.com or LinkedIn.
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CONTACT
Dr. Jonathan Kaufman, CEO
Lipella Pharmaceuticals
Info@Lipella.com
1-412-894-1853
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
FAQ
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