Palisade Bio Cleared by Health Canada to Commence Phase 1 Clinical Study for Lead Program, PALI-2108 for the Treatment of Ulcerative Colitis (UC)
Palisade Bio (Nasdaq: PALI) has received a No Objection Letter from Health Canada for its Phase 1 clinical study of PALI-2108, an oral PDE4 inhibitor prodrug for treating Ulcerative Colitis (UC). The study will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and UC patients. The trial design includes Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), and food effects (FE) cohorts, with approximately 90 patients planned for enrollment.
The primary objective is to assess safety and tolerability, with secondary objectives focusing on pharmacokinetics. Exploratory objectives include examining PDE4-related biomarkers and UC-specific markers. Palisade Bio aims to commence site initiation and enrollment before year-end. The company believes PALI-2108 could be the first approved PDE4 inhibitor for UC, addressing a significant medical need in a market expected to reach nearly $10 billion by 2028.
Palisade Bio (Nasdaq: PALI) ha ricevuto una Lettera di Non Obiezione da Health Canada per il suo studio clinico di fase 1 su PALI-2108, un pro-farmaco inibitore della PDE4 per il trattamento della Colite Ulcerosa (CU). Lo studio valuterà la sicurezza, la tollerabilità, la farmacocinetica e la farmacodinamica in volontari sani e pazienti con CU. Il disegno della sperimentazione include coorti per Dose Singola Ascendente (SAD), Dose Multipla Ascendente (MAD) e effetti del cibo (FE), con circa 90 pazienti previsti per l'arruolamento.
L'obiettivo primario è valutare la sicurezza e la tollerabilità, mentre gli obiettivi secondari si concentrano sulla farmacocinetica. Gli obiettivi esplorativi includono l'esame dei biomarcatori correlati alla PDE4 e dei marcatori specifici per la CU. Palisade Bio punta ad avviare l'inizio del sito e l'arruolamento prima della fine dell'anno. L'azienda ritiene che PALI-2108 potrebbe essere il primo inibitore della PDE4 approvato per la CU, rispondendo a un'importante esigenza medica in un mercato che si prevede raggiunga quasi 10 miliardi di dollari entro il 2028.
Palisade Bio (Nasdaq: PALI) ha recibido una Carta de No Objeción de Health Canada para su estudio clínico de fase 1 sobre PALI-2108, un profármaco inhibidor de la PDE4 para el tratamiento de Colitis Ulcerosa (CU). El estudio evaluará la seguridad, la tolerancia, la farmacocinética y la farmacodinámica en voluntarios sanos y pacientes con CU. El diseño del ensayo incluye cohortes de Dosis Ascendente Única (SAD), Dosis Múltiple Ascendente (MAD) y efectos de los alimentos (FE), con aproximadamente 90 pacientes planificados para la inclusión.
El objetivo principal es evaluar la seguridad y la tolerancia, mientras que los objetivos secundarios se centran en la farmacocinética. Los objetivos exploratorios incluyen el examen de biomarcadores relacionados con la PDE4 y marcadores específicos para la CU. Palisade Bio espera comenzar la iniciación del sitio y la inclusión antes de fin de año. La empresa cree que PALI-2108 podría ser el primer inhibidor de la PDE4 aprobado para la CU, abordando una necesidad médica significativa en un mercado que se espera alcance casi 10 mil millones de dólares para 2028.
Palisade Bio(Nasdaq: PALI)가 PALI-2108에 대한 1상 임상 연구에 대해 캐나다 보건부로부터 불승인서(No Objection Letter)를 받았습니다. 이는 궤양성 대장염(UC) 치료를 위한 경구 PDE4 억제제 프로드럭입니다. 본 연구는 건강한 자원봉사자 및 UC 환자에서 안전성, 내약성, 약동학 및 약리작용을 평가할 예정입니다. 임상 시험 설계는 단일 용량 상승(SAD), 다중 용량 상승(MAD), 식사 영향(FE) 코호트를 포함하며, 약 90명의 환자가 등록될 예정입니다.
주요 목표는 안전성과 내약성을 평가하는 것이며, 부차적 목표는 약동학에 중점을 둡니다. 탐색적 목표에는 PDE4 관련 바이오마커와 UC 특정 마커를 검토하는 것이 포함됩니다. Palisade Bio는 연말 이전에 사이트 개시 및 등록을 시작할 계획입니다. 회사는 PALI-2108이 UC에 대해 승인된 최초의 PDE4 억제제가 될 수 있다고 믿고 있으며, 2028년까지 거의 100억 달러에 달할 것으로 예상되는 시장의 중요한 의료 수요를 충족합니다.
Palisade Bio (Nasdaq: PALI) a reçu une Lettre de Non-Objection de la part de Santé Canada pour son étude clinique de phase 1 sur PALI-2108, un pro-médicament inhibiteur de la PDE4 pour traiter la Colite Ulcerative (CU). L'étude évaluera la sécurité, la tolérance, la pharmacocinétique et la pharmacodynamique chez des volontaires sains et des patients atteints de CU. Le design de l'essai inclut des cohortes de Posologie Unique Ascendante (SAD), Posologie Multiple Ascendante (MAD) et effets alimentaires (FE), avec environ 90 patients prévus pour l'inscription.
L'objectif principal est d'évaluer la sécurité et la tolérance, tandis que les objectifs secondaires se concentrent sur la pharmacocinétique. Les objectifs exploratoires comprennent l'examen des biomarqueurs liés à la PDE4 et des marqueurs spécifiques à la CU. Palisade Bio prévoit de commencer l'initiation du site et l'inscription avant la fin de l'année. La société croit que PALI-2108 pourrait être le premier inhibiteur de la PDE4 approuvé pour la CU, répondant à un besoin médical significatif dans un marché qui devrait atteindre près de 10 milliards de dollars d'ici 2028.
Palisade Bio (Nasdaq: PALI) hat von Health Canada ein No Objection Letter für seine Phase-1-Studie zu PALI-2108, einem oralen PDE4-Inhibitor-Prodrug zur Behandlung von Ulcerativer Kolitis (UC), erhalten. Die Studie wird Sicherheit, Verträglichkeit, Pharmakokinetik und Pharmakodynamik bei gesunden Probanden und UC-Patienten untersuchen. Das Studiendesign umfasst Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) und Nahrungswirkung (FE) Kohorten, mit etwa 90 Patienten, die zur Aufnahme geplant sind.
Das primäre Ziel ist die Bewertung von Sicherheit und Verträglichkeit, während die sekundären Ziele sich auf die Pharmakokinetik konzentrieren. Explorative Ziele umfassen die Untersuchung von PDE4-bezogenen Biomarkern und UC-spezifischen Markern. Palisade Bio plant, die Standortinitiierung und Einschreibung vor Jahresende zu beginnen. Das Unternehmen ist der Meinung, dass PALI-2108 der erste zugelassene PDE4-Inhibitor für UC sein könnte, der einen bedeutenden medizinischen Bedarf auf einem Markt adressiert, der bis 2028 voraussichtlich fast 10 Milliarden Dollar erreichen wird.
- Received No Objection Letter from Health Canada for Phase 1 clinical study of PALI-2108
- On track to commence Phase 1 clinical trial before year-end
- PALI-2108 has potential to be the first approved PDE4 inhibitor for Ulcerative Colitis
- Global Ulcerative Colitis market expected to grow to nearly $10 Billion by 2028
- None.
Insights
This announcement marks a significant milestone for Palisade Bio's PALI-2108 program. Receiving a No Objection Letter from Health Canada for the Phase 1 clinical trial is a important step in the drug development process. The study design, including SAD/MAD components and a UC patient cohort, is comprehensive and will provide valuable data on safety, tolerability and pharmacokinetics.
Key points to consider:
- The global UC market is projected to reach
$10 billion by 2028, indicating substantial market potential. - PALI-2108's unique mechanism as a locally bioactivated PDE4 inhibitor could offer advantages over existing treatments.
- The inclusion of UC patients in the Phase 1 study may provide early efficacy signals.
- The focus on an oral medication addresses an unmet need in UC treatment.
While this news is positive, investors should note that Phase 1 trials primarily assess safety and efficacy data will be The true potential of PALI-2108 will become clearer in later-stage trials.
The development of PALI-2108 addresses a significant unmet need in ulcerative colitis treatment. Current therapies achieve complete remission in less than
Key considerations:
- Local bioactivation in the colon may improve efficacy while reducing systemic side effects.
- Inclusion of biomarkers like hsCRP and fecal calprotectin in the study design will provide valuable insights into the drug's effects on inflammation.
- The Modified Mayo score and histological assessments will offer early indications of clinical benefit.
However, it's important to note that many promising UC treatments have failed in later-stage trials. The true efficacy and safety profile of PALI-2108 will only become clear after more extensive clinical testing.
– Company has received a No Objection Letter from Health Canada in response to submission of its Phase 1 Clinical Trial Application (CTA)
– The study is a Phase 1 Single Ascending Dose (SAD) /Multiple Ascending Dose (MAD) and food effects (FE) and includes multiple dose treatment of UC patients; Global UC market is expected to grow to nearly
Carlsbad, CA, Oct. 10, 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 announced that it has received a No Objection Letter from Health Canada for its Phase 1 human clinical study for PALI-2108 for the treatment of UC.
“We are thrilled to receive a No Objection Letter from Health Canada in response to our Clinical Trial Application. This achievement marks the most important milestone to date for our PALI-2108 development program. We continue to believe in the potential of PALI-2108 to be the first approved PDE4 inhibitor for UC and more importantly, provide a much-needed effective and safe solution for UC patients still experiencing significant medical need. Our team remains focused on continuing preparations for the initiation of our Phase 1 clinical trial which is on track to commence before year end,” commented J.D. Finley, Chief Executive Officer.
PALI-2108 is an orally administered PDE4 inhibitor prodrug which is locally bioactivated in the colon and is in development for patients affected by UC. The Phase 1 study will evaluate PALI-2108 in a single-center, double-blind, placebo-controlled study focused on safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers, alongside an open-label study involving a patient cohort with UC. As previously announced, the Company has established dose levels and trial design for PALI-2108 and plans to enroll approximately 90 patients across the SAD, FE, MAD and UC cohorts.
“Patients are actively seeking new and more effective treatment options for their ulcerative colitis. Currently, existing therapies achieve complete remission in fewer than a quarter of patients, and many of the most effective treatments involve injections or carry black box warnings due to serious side effects. A safe and effective oral medication for UC would be highly desirable for the majority of patients,” said Florian Rieder, MD, a member of the Palisade Bio Clinical Advisory Board and Associate Staff in the Department of Gastroenterology, Hepatology, and Nutrition, as well as an Investigator in the Department of Pathobiology at the Cleveland Clinic.
The primary objective of the study will be to assess the safety and tolerability of single (healthy subjects) and repeated (healthy subjects and UC patients) oral doses of PALI-2108. Secondary objectives include determining the plasma, urinary, and fecal (MAD healthy subjects and UC patients only) pharmacokinetics (PK) of PALI-2108 and its metabolites following PALI-2108 single (healthy subjects) and repeated (healthy subjects and UC patients) oral doses, as well as the effect of food on the PK of PALI-2108 and its metabolites following a single oral dose in healthy subjects. Exploratory objectives will include PDE4-related pharmacodynamic (PD) biomarkers, concentrations of the active form of PALI-2108, high sensitivity C-reactive protein (hsCRP), fecal calprotectin (CalPro), colonic tissue Absolute Lymphocyte Count (ALC), Modified Mayo score, as well as colonic histological changes in UC patients following repeated PALI-2108 oral doses.
Preparations for the clinical study remain ongoing and the Company is on track commence site initiation and enrollment for the study before year end.
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; the timing and outcome of our current and anticipated applications and studies related to our product candidates; 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 most recent Quarterly Report on Form 10-Q for the period ended June 30, 2024, filed with the Securities and Exchange Commission on March 26, 2024 and August 12, 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
908-824-0775
PALI@jtcir.com
FAQ
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