Palisade Bio Selects Dose for Upcoming Phase 1 Clinical Study of PALI-2108 for Ulcerative Colitis
Palisade Bio (Nasdaq: PALI) has announced progress in developing PALI-2108, its lead drug candidate for Ulcerative Colitis (UC). The company has determined the Maximum Recommended Starting Dose (MRSD) for human trials using comprehensive scaling approaches and modeling. Key findings from pharmacokinetic (PK) modeling and simulations indicate that dosing regimens with minimal accumulation are both safe and within the doses showing maximal efficacy in animal models. Palisade Bio has established dose levels and trial design for PALI-2108, an orally administered, colon-specific PDE4 inhibitor prodrug. The upcoming Phase 1 clinical trial, set to commence before year-end, will evaluate safety, tolerability, and PK in healthy volunteers and UC patients, as well as pharmacodynamics in UC patients.
Palisade Bio (Nasdaq: PALI) ha annunciato progressi nello sviluppo di PALI-2108, il suo principale candidato farmaco per Colite Ulcerosa (UC). L'azienda ha determinato la Dose Iniziale Massima Raccomandata (MRSD) per le prove umane utilizzando approcci di scaling completi e modellazione. Le scoperte chiave dalla modellazione e simulazioni farmacocinetiche (PK) indicano che i regimi di dosaggio con accumulo minimo sono sia sicuri che all'interno delle dosi che mostrano la massima efficacia nei modelli animali. Palisade Bio ha stabilito i livelli di dose e il design della prova per PALI-2108, un pro-farmaco inibitore PDE4 specifico per il colon, somministrato per via orale. L'imminente trial clinico di Fase 1, che inizierà prima della fine dell'anno, valuterà sicurezza, tollerabilità e PK in volontari sani e pazienti con UC, oltre alla farmacodinamica nei pazienti con UC.
Palisade Bio (Nasdaq: PALI) ha anunciado avances en el desarrollo de PALI-2108, su principal candidato a fármaco para Colitis Ulcerosa (UC). La compañía ha determinado la Dosis Inicial Máxima Recomendada (MRSD) para ensayos en humanos utilizando enfoques de escalado integrales y modelado. Hallazgos clave de la modelación y simulaciones farmacocinéticas (PK) indican que los regímenes de dosificación con acumulación mínima son seguros y se encuentran dentro de las dosis que muestran la máxima eficacia en modelos animales. Palisade Bio ha establecido los niveles de dosificación y el diseño del ensayo para PALI-2108, un profármaco inhibidor de PDE4 específico del colon, administrado por vía oral. El próximo ensayo clínico de Fase 1, que comenzará antes de fin de año, evaluará la seguridad, tolerabilidad y PK en voluntarios sanos y pacientes con UC, así como la farmacodinamia en pacientes con UC.
Palisade Bio (Nasdaq: PALI)는 대장염(UC)을 위한 주요 약물 후보인 PALI-2108의 개발 진전을 발표했습니다. 이 회사는 포괄적인 스케일링 접근 방식과 모델링을 사용하여 인간 시험에 대한 최대 추천 시작 용량(MRSD)을 결정했습니다. 약리학적 모델링(PK) 및 시뮬레이션에서의 주요 발견은 최소한의 축적이 있는 투여 요법이 안전하며 동물 모델에서 최대 효능을 보이는 용량 내에 있음을 나타냅니다. Palisade Bio는 경구 투여되는 대장 특이 PDE4 억제제 프로드럭인 PALI-2108의 용량 수준과 시험 설계를 확립했습니다. 연말 전에 시작될 예정인 임상 시험 1상은 건강한 자원자와 UC 환자의 안전성, 내약성 및 PK를 평가하고, UC 환자에서의 약물역동학을 평가할 예정입니다.
Palisade Bio (Nasdaq: PALI) a annoncé des progrès dans le développement de PALI-2108, son principal candidat médicament pour la colite ulcéreuse (UC). L'entreprise a déterminé la dose de départ maximale recommandée (MRSD) pour les essais humains en utilisant des approches de mise à l'échelle et de modélisation complètes. Les résultats clés de la modélisation et des simulations pharmacocinétiques (PK) indiquent que les schémas posologiques avec une accumulation minimale sont à la fois sûrs et dans les doses montrant une efficacité maximale dans les modèles animaux. Palisade Bio a établi les niveaux de dose et le design de l'essai pour PALI-2108, un pro-médicament inhibiteur de PDE4 spécifique au côlon, administré par voie orale. Le prochain essai clinique de phase 1, qui devrait commencer avant la fin de l'année, évaluera la sécurité, la tolérabilité et la PK chez des volontaires sains et des patients UC, ainsi que la pharmacodynamie chez les patients UC.
Palisade Bio (Nasdaq: PALI) hat Fortschritte in der Entwicklung von PALI-2108, seinem Hauptmedikamentenkandidaten für Colitis ulcerosa (UC), bekannt gegeben. Das Unternehmen hat die maximale empfohlene Startdosis (MRSD) für menschliche Studien unter Verwendung umfassender Skalierungsansätze und Modellierung bestimmt. Wichtige Ergebnisse aus der pharmakokinetischen (PK) Modellierung und Simulationen zeigen, dass Dosierungsschemata mit minimaler Akkumulation sowohl sicher sind als auch innerhalb der Dosen liegen, die maximale Wirksamkeit in Tiermodellen zeigen. Palisade Bio hat Dosisniveaus und das Design der Studie für PALI-2108, einen oral verabreichten, kolonspezifischen PDE4-Inhibitor-Prodrug, festgelegt. Die bevorstehende Phase-1-Studie, die vor Jahresende beginnen soll, wird die Sicherheit, Verträglichkeit und PK bei gesunden Freiwilligen und UC-Patienten sowie die Pharmakodynamik bei UC-Patienten bewerten.
- Phase 1 clinical trial of PALI-2108 for Ulcerative Colitis on track to start before year-end
- Comprehensive preclinical studies completed, including PK studies across multiple species
- PK modeling indicates safe dosing regimens within efficacious range from animal models
- Established starting dose for healthy volunteers with significant safety margin
- None.
Insights
The selection of a dose for PALI-2108's Phase 1 clinical study is a significant milestone for Palisade Bio. This progress indicates the company is on track to initiate human trials for their lead drug candidate in ulcerative colitis (UC) treatment. The comprehensive approach to dose determination, including multi-species pharmacokinetic studies and GLP toxicology studies, demonstrates a thorough scientific process.
The development of a colon-specific PDE4 inhibitor could potentially offer a new treatment option for UC patients, addressing a significant unmet medical need. The oral administration and local action of PALI-2108 may provide advantages over existing systemic treatments, potentially improving efficacy and reducing side effects.
However, investors should note that Phase 1 trials primarily focus on safety and efficacy data will come later. The success in preclinical stages is promising, but many drug candidates fail in human trials. The upcoming Phase 1 results will be important in determining PALI-2108's future potential.
This news is potentially positive for Palisade Bio's financial outlook. Advancing to Phase 1 trials represents a de-risking event, which could attract investor interest and potentially lead to increased valuation. However, it's important to note that the company will likely face increased R&D expenses as it enters clinical trials.
The market for UC treatments is substantial, with global sales projected to reach
Palisade Bio's ability to fund ongoing research and potential future clinical trials will be critical. The company's current cash position and burn rate should be closely monitored. Potential future financing rounds or partnerships could impact shareholder value.
– Phase 1 human clinical study of PALI-2108 for the treatment of Ulcerative Colitis (UC) on track to commence before year end
– Based on the modeling and simulations, Palisade has established dose levels and trial design for PALI-2108
Carlsbad, CA, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio” or the “Company”), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today provided a progress update on the advancement of development for its lead drug candidate, PALI-2108 towards initiation of Phase 1 clinical trials in healthy volunteers and patients with Ulcerative Colitis (UC). PALI-2108 is an orally administered, locally acting colon-specific PDE4 inhibitor prodrug in development for patients affected by UC.
“To establish the Maximum Recommended Starting Dose (MRSD) for human trials, we utilized several complementary scaling approaches. These methods included integrating data from IV and oral (PO) administrations of PALI-2108 across various species. By modeling total PK data, we have gathered data that we believe accurately translates to exposure in humans and ensures a safe and scientifically grounded starting point for our upcoming planned clinical studies. We are pleased with the progress made and look forward to commencing our Phase 1 clinical trial before the end of the year,” commented Dr. Mitch Jones, CMO of Palisade Bio.
The Company has completed an extensive range of studies to determine the starting dose for PALI-2108 in its planned Phase 1 study. The preclinical studies included pharmacodynamic (PD) studies in mice, pharmacokinetic (PK) studies across multiple species (mice, rats, dogs, and monkeys), and a series of in vitro experiments to profile PALI-2108’s drug metabolism and pharmacokinetics (DMPK) characteristics. Additionally, the Company has completed its pivotal Good Laboratory Practice (GLP) safety and toxicology studies which have provided relevant data for this determination.
Key Findings from PK Modeling and Simulations
- Comprehensive simulations were conducted for both single and multiple dose administrations. Scenarios ranged over expected Phase 1 dosing levels and assessed both single and multiple daily doses. The simulations indicated that dosing regimens with minimal accumulation are both safe and within the doses that demonstrated maximal efficacy in animal models.
- A robust human PK model was constructed by scaling preclinical PK parameters to predict human exposure. This model incorporated both the PK of PALI-2108 and its active metabolite, PALI-0008, providing a solid foundation for the Phase 1 trials.
Based on the modeling and simulations, Palisade Bio has determined a starting dose for healthy volunteers which includes a several orders of magnitude safety margin. The dose levels and trial designs have been selected to ensure patient safety while maximizing the potential therapeutic benefits of PALI-2108. The upcoming Phase 1 clinical trial will focus on evaluating the safety, tolerability, and PK of PALI-2108 in healthy volunteers, UC patients, as well as PD in UC patients. Continuous monitoring and assessment will guide future dose escalation and therapeutic strategies.
About Palisade Bio
Palisade Bio is a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, please go to www.palisadebio.com.
Forward Looking Statements
This communication contains “forward-looking” statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the extent of our cash runway; our ability to successfully develop our licensed technologies; estimates about the size and growth potential of the markets for our product candidates, and our ability to serve those markets, including any potential revenue generated; future regulatory, judicial, and legislative changes or developments in the United States (U.S.) and foreign countries and the impact of these changes; our ability to maintain the Nasdaq listing of our securities; our ability to build a commercial infrastructure in the U.S. and other markets; our ability to compete effectively in a competitive industry; our ability to identify and qualify manufacturers to provide API and manufacture drug product; our ability to enter into commercial supply agreements; the success of competing technologies that are or may become available; our ability to attract and retain key scientific or management personnel; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; our ability to obtain funding for our operations; our ability to attract collaborators and strategic partnerships; and the impact of the COVID-19 pandemic or any global event on our business, and operations, and supply. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon the Company’s current expectations. Forward-looking statements involve risks and uncertainties. The Company’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the Company’s ability to advance its nonclinical and clinical programs, the uncertain and time-consuming regulatory approval process; and the Company’s ability to secure additional financing to fund future operations and development of its product candidates. Additional risks and uncertainties can be found in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on March 26, 2024 and May 13, 2024, respectively. These forward-looking statements speak only as of the date hereof and the Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Investor Relations Contact
JTC Team, LLC
Jenene Thomas
833-475-8247
PALI@jtcir.com
FAQ
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