Palisade Bio Completes All Five SAD Cohorts and Advances to MAD Cohorts of Phase 1a/b Study of PALI-2108 for Treatment of Ulcerative Colitis
Palisade Bio (NASDAQ: PALI) has successfully completed all five Single Ascending Dose (SAD) cohorts and advanced to Multiple Ascending Dose (MAD) cohorts in its Phase 1a/b study of PALI-2108 for Ulcerative Colitis treatment. The SAD study, testing doses from 15mg to 450mg, demonstrated favorable safety and tolerability with no serious adverse events or treatment-related laboratory abnormalities.
The preliminary pharmacokinetic analysis showed PALI-2108's delayed-release and extended-release characteristics, providing sustained, dose-dependent drug exposure with high local concentrations in the colon. Only mild treatment-emergent adverse events were observed at the highest dose of 450mg.
The ongoing MAD portion will assess repeat dosing and further evaluate safety and pharmacokinetics in both healthy volunteers and UC patients. The company remains on track to report topline data in the first half of 2025.
Palisade Bio (NASDAQ: PALI) ha completato con successo tutti e cinque i cohort di Dosaggio Singolo Ascendente (SAD) ed è avanzata ai cohort di Dosaggio Multiplo Ascendente (MAD) nel suo studio di Fase 1a/b su PALI-2108 per il trattamento della colite ulcerosa. Lo studio SAD, che ha testato dosi da 15mg a 450mg, ha dimostrato un profilo di sicurezza e tollerabilità favorevole, senza gravi eventi avversi o anomalie di laboratorio legate al trattamento.
L'analisi preliminare della farmacocinetica ha rivelato caratteristiche di rilascio ritardato e prolungato di PALI-2108, fornendo un'esposizione sostenuta e dose-dipendente al farmaco con alte concentrazioni locali nel colon. Solo eventi avversi lievi emergenti dal trattamento sono stati osservati alla dose massima di 450mg.
La parte MAD in corso valuterà il dosaggio ripetuto e approfondirà la valutazione della sicurezza e della farmacocinetica sia in volontari sani che in pazienti con colite ulcerosa. L'azienda rimane in linea per riportare i dati preliminari nella prima metà del 2025.
Palisade Bio (NASDAQ: PALI) ha completado con éxito todos los cinco grupos de Dosis Ascendente Única (SAD) y ha avanzado a los grupos de Dosis Ascendente Múltiple (MAD) en su estudio de Fase 1a/b sobre PALI-2108 para el tratamiento de la colitis ulcerosa. El estudio SAD, que probó dosis desde 15mg hasta 450mg, demostró un perfil de seguridad y tolerabilidad favorable, sin eventos adversos graves o anormalidades de laboratorio relacionadas con el tratamiento.
El análisis farmacocinético preliminar mostró características de liberación retardada y liberación prolongada de PALI-2108, proporcionando una exposición al fármaco sostenida y dependiente de la dosis con altas concentraciones locales en el colon. Solo se observaron eventos adversos leves emergentes del tratamiento en la dosis más alta de 450mg.
La parte MAD en curso evaluará la dosificación repetida y evaluará más a fondo la seguridad y la farmacocinética tanto en voluntarios sanos como en pacientes con colitis ulcerosa. La empresa sigue en camino de informar los datos preliminares en la primera mitad de 2025.
팔리세이드 바이오 (NASDAQ: PALI)는 PALI-2108의 궤양성 대장염 치료를 위한 1a/b 단계 연구에서 다섯 개의 단일 상승 용량(SAD) 집단을 성공적으로 완료하고 다중 상승 용량(MAD) 집단으로 진행했습니다. SAD 연구에서는 15mg에서 450mg까지의 용량을 시험하였으며, 심각한 부작용이나 치료 관련 실험실 이상 없이 긍정적인 안전성과 내약성을 입증했습니다.
초기 약물의 약물 동태 분석은 PALI-2108의 지연 방출 및 지속 방출 특성을 보여주었으며, 대장에서 높은 국소 농도로 지속적이고 용량 의존적인 약물 노출을 제공합니다. 450mg의 가장 높은 용량에서는 경미한 치료 발생 부작용만 관찰되었습니다.
진행 중인 MAD 부분은 반복 용량을 평가하고 건강한 자원봉사자와 UC 환자 모두에서 안전성과 약물 동태를 추가로 평가할 것입니다. 회사는 2025년 상반기 내에 주요 데이터를 보고할 예정입니다.
Palisade Bio (NASDAQ: PALI) a réussi à compléter les cinq cohortes de Dose Unique Ascendante (SAD) et a avancé aux cohortes de Dose Multiple Ascendante (MAD) dans son étude de Phase 1a/b sur PALI-2108 pour le traitement de la colite ulcéreuse. L'étude SAD, testant des doses de 15mg à 450mg, a démontré un profil de sécurité et de tolérance favorable, sans événements indésirables graves ni anomalies de laboratoire liées au traitement.
L'analyse pharmacocinétique préliminaire a montré les caractéristiques de libération retardée et prolongée de PALI-2108, offrant une exposition au médicament durable et dépendante de la dose avec de fortes concentrations locales dans le côlon. Seuls des événements indésirables légers liés au traitement ont été observés à la dose maximale de 450mg.
La partie MAD en cours évaluera la posologie répétée et examinera plus en détail la sécurité et la pharmacocinétique tant chez des volontaires sains que chez des patients atteints de colite ulcéreuse. L'entreprise reste sur la bonne voie pour communiquer les données principales au cours de la première moitié de 2025.
Palisade Bio (NASDAQ: PALI) hat erfolgreich alle fünf Gruppen mit Einzel-Dosierung (SAD) abgeschlossen und ist zu den Gruppen mit Mehrfach-Dosierung (MAD) in seiner Phase 1a/b Studie zu PALI-2108 zur Behandlung von Colitis ulcerosa übergegangen. Die SAD-Studie, die Dosen von 15mg bis 450mg getestet hat, zeigte ein günstiges Sicherheits- und Verträglichkeitsprofil ohne schwerwiegende unerwünschte Ereignisse oder behandlungsbezogene Laboranomalien.
Die vorläufige pharmakokinetische Analyse zeigte die verzögerte und verlängerte Freisetzung von PALI-2108, was eine nachhaltige, dosierungsabhängige Arzneimittelexposition mit hohen lokalen Konzentrationen im Dickdarm bietet. Nur milde behandlungsbedingte unerwünschte Ereignisse wurden bei der höchsten Dosis von 450mg beobachtet.
Der laufende MAD-Teil wird die wiederholte Dosierung bewerten und Sicherheit sowie Pharmakokinetik sowohl bei gesunden Probanden als auch bei UC-Patienten weiter überprüfen. Das Unternehmen ist weiterhin auf Kurs, die Hauptdaten in der ersten Hälfte des Jahres 2025 zu berichten.
- Successful completion of all five SAD cohorts with favorable safety profile
- No serious adverse events or treatment-related laboratory abnormalities reported
- Demonstrated desired pharmacokinetic properties with sustained drug exposure
- Study progressing on schedule with topline data expected H1 2025
- Mild treatment-emergent adverse events observed at 450mg dose level
Insights
The completion of SAD cohorts with positive safety data and progression to MAD cohorts represents a critical development milestone for PALI-2108. The preliminary data shows favorable safety profile across all five dose levels (15mg to 450mg) with only mild TEAEs at the highest dose (450mg). The absence of SAEs, dose reductions and laboratory abnormalities is particularly encouraging for an early-stage drug candidate.
The pharmacokinetic data demonstrating delayed-release and extended-release characteristics with high colon concentrations is important for UC treatment efficacy. The study's comprehensive biomarker analysis approach, including hsCRP, CalPro and tissue histology, will provide robust evidence of biological activity. For a micro-cap company (
This clinical progress significantly de-risks PALI-2108's development pathway. The successful completion of all SAD cohorts with clean safety data enhances the probability of clinical success, particularly important given PALI-2108 is a novel chemical entity in the PDE4 inhibitor class. The advancement to MAD cohorts while maintaining the H1 2025 timeline for topline data demonstrates efficient trial execution.
The established success of other PDE4 inhibitors in inflammatory conditions provides regulatory precedent, while PALI-2108's targeted colon delivery could offer competitive advantages. For investors, this milestone reduces early-stage clinical risk and could catalyze value inflection upon MAD data readout. The micro-cap valuation suggests significant upside potential if positive trends continue, though careful consideration of cash runway is warranted.
Company on track to report topline data in first half of 2025
Positive preliminary data from all five single ascending dose (SAD) cohorts ranging from 15mg to 450mg support safety and tolerability of PALI-2108
Continued progress toward Phase 1b/2a of PALI-2108 trial for the treatment of UC
Carlsbad, CA, Jan. 16, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc, (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or the “Company”), a clinical-stage biopharmaceutical company focused on developing novel therapeutics for autoimmune, inflammatory and fibrotic diseases, today announced the completion of all five planned Single Ascending Dose (SAD) cohorts and the commencement of the Multiple Ascending Dose (MAD) cohorts in its ongoing Phase 1a/b study of PALI-2108 for the treatment of Ulcerative Colitis (UC).
Preliminary data from the SAD portion of the study, which evaluated doses ranging from 15 mg to 450 mg of PALI-2108, support that the drug was well-tolerated across all dose levels. Importantly, there were no treatment-related dose reductions, serious adverse events (SAEs), or treatment-related laboratory abnormalities observed. Treatment-emergent adverse events (TEAEs) were mild and occurred only at the highest dose of 450 mg. Importantly, there were no EKG abnormalities or other serious safety concerns, underscoring the favorable safety profile of PALI-2108.
In addition to its safety and tolerability, preliminary pharmacokinetic (PK) analysis from the SAD portion of the study showed the delayed-release and extended-release characteristics of PALI-2108, which provides sustained, dose-dependent drug exposure with high local concentrations in the colon, a key feature for the targeted treatment of UC. This preliminary data provides strong support for the ongoing MAD portion of the trial, which aims to assess repeat dosing and further evaluate the safety and pharmacokinetics of PALI-2108 in both healthy volunteers and UC patients.
“We are excited to move from the SAD to the MAD portion of our Phase 1a/b study of PALI-2108, a significant milestone that brings us one-step closer to delivering an innovative, safe, and effective treatment option for UC patients,” said Dr. Mitch Jones, Chief Medical Officer of Palisade. “The preliminary data from the SAD cohorts have reinforced our confidence in PALI-2108’s safety profile, and we remain on track to report topline data in the first half of 2025.”
The primary aim of this single-center Phase 1a/b study is to evaluate the safety, tolerability, and PK of PALI-2108 in healthy volunteers as well as to evaluate the safety, tolerability, PK and pharmacodynamics PD in patients with UC. Several PDE4 inhibitors have received market approval in both inflammatory and fibrotic disease; however, PALI-2108 represents a new chemical entity that has not been previously administered to humans. Biomarkers, including serum high sensitivity C-reactive protein (hsCRP), and fecal calprotectin (CalPro), along with colonic tissue histological assessments, will be employed to provide further insights into the drug’s effects. The analysis of colon tissue will include the study drug and metabolite levels, PDE4 expression, cyclic adenosine monophosphate (cAMP) levels, Absolute Lymphocyte Count (ALC), and related PD biomarkers, which are crucial for understanding the drug’s mechanism and efficacy.
For more information about the Phase 1a/b clinical study, visit clinicaltrials.gov and reference identifier NCT06663605.
About Palisade Bio
Palisade Bio is a clinical-stage 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 can transform the treatment landscape. For more information, please go to www.palisadebio.com.
Forward Looking Statements
Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding the safety and tolerability, PK and drug release characteristics of PALI-2108 based on preliminary data from the SAD portion of the Company’s Phase 1b/2a clinical study, indications and anticipated benefits of PALI-2108 and the expected timing of the release of topline data from the Phase 1b/2a clinical study. These forward-looking statements are based on 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 is heavily dependent on the success of PALI-2108, which is in the early stages of clinical development and may not successfully progress through clinical development or receive regulatory approval; preliminary clinical study results or the results from earlier preclinical studies may not be predictive of final or future results and unexpected adverse side effects or inadequate efficacy of PALI-2108 may limit its development, regulatory approval and/or commercialization; the Company needs to raise significant additional funds to support its operations and the continued development of PALI-2108; the timing and outcome of the Company’s current and anticipated clinical studies related to its product candidates; indications of use and estimates about the size and growth potential of the markets for the Company’s product candidates, and its ability to serve those markets, including any potential revenue generated; the Company’s ability to maintain the Nasdaq listing of its securities; the Company’s ability to compete effectively in a competitive industry; the Company’s ability to identify and qualify manufacturers to provide API and manufacture drug product; the Company’s ability to enter into commercial supply agreements; the Company’s ability to attract and retain key scientific or management personnel; the accuracy of the Company’s estimates regarding expenses, future revenues, capital requirements and needs for additional financing; and the impact of any global event on the Company’s business, and operations, and supply. 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, filed with the Securities and Exchange Commission (“SEC”) on March 26, 2024, and the Quarterly Reports on Form 10-Q or other SEC filings that are filed thereafter. Investors are cautioned not to put undue reliance on these forward-looking statements. 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
What were the key findings from PALI-2108's Phase 1a/b SAD cohorts for Ulcerative Colitis?
When will Palisade Bio (PALI) report topline data for PALI-2108's Phase 1a/b study?
What dose ranges were tested in PALI-2108's SAD cohorts?
What are the pharmacokinetic properties demonstrated by PALI-2108 in the Phase 1a/b study?
What biomarkers will be used to evaluate PALI-2108's effectiveness in UC patients?
