Palisade Bio Completes Dosing in Phase 1a Portion of Ongoing Phase 1a/b Study of PALI-2108
Palisade Bio (NASDAQ: PALI) has successfully completed the Phase 1a portion of its Phase 1a/b study for PALI-2108, a treatment for Ulcerative Colitis (UC). The study included five Single Ascending Dose (SAD) cohorts, four Multiple Ascending Dose (MAD) cohorts, and food effects crossover.
Preliminary results showed promising safety data with no serious adverse events (SAEs) or treatment-emergent adverse events (TEAEs) related to laboratory values or EKGs. Several MAD cohorts (15mg-30mg BID) were completed within the expected therapeutic dose range, with minimal adverse events. Only one withdrawal occurred in the highest 50mg twice-daily dosage cohort.
The company is currently screening and dosing patients for the Phase 1b UC cohort, with one subject having completed this portion. Topline data from Phase 1a is expected by May 2025, with complete Phase 1a/b results anticipated in the first half of 2025.
Palisade Bio (NASDAQ: PALI) ha completato con successo la parte 1a del suo studio di fase 1a/b per PALI-2108, un trattamento per la colite ulcerosa (UC). Lo studio ha incluso cinque coorti di dosi ascendenti singole (SAD), quattro coorti di dosi ascendenti multiple (MAD) e un crossover sugli effetti del cibo.
I risultati preliminari hanno mostrato dati di sicurezza promettenti, senza eventi avversi gravi (SAE) o eventi avversi emergenti dal trattamento (TEAE) correlati ai valori di laboratorio o agli EKG. Diverse coorti MAD (15mg-30mg BID) sono state completate all'interno dell'intervallo di dose terapeutica previsto, con eventi avversi minimi. Si è verificato solo un ritiro nella coorte con la dose più alta di 50mg due volte al giorno.
L'azienda sta attualmente eseguendo screening e somministrando dosi ai pazienti per la coorte UC di fase 1b, con un soggetto che ha completato questa parte. I dati preliminari della fase 1a sono attesi entro maggio 2025, con i risultati completi della fase 1a/b previsti nella prima metà del 2025.
Palisade Bio (NASDAQ: PALI) ha completado con éxito la parte 1a de su estudio de fase 1a/b para PALI-2108, un tratamiento para la colitis ulcerosa (UC). El estudio incluyó cinco cohortes de dosis ascendentes únicas (SAD), cuatro cohortes de dosis ascendentes múltiples (MAD) y un cruce sobre los efectos de los alimentos.
Los resultados preliminares mostraron datos de seguridad prometedores, sin eventos adversos graves (SAE) ni eventos adversos emergentes del tratamiento (TEAE) relacionados con los valores de laboratorio o los EKG. Varias cohortes MAD (15mg-30mg BID) se completaron dentro del rango de dosis terapéuticas esperado, con eventos adversos mínimos. Solo se produjo una retirada en la cohorte de la dosis más alta de 50mg dos veces al día.
La empresa está actualmente realizando el cribado y la dosificación de pacientes para la cohorte UC de fase 1b, con un sujeto que ha completado esta parte. Se esperan los datos preliminares de la fase 1a para mayo de 2025, con los resultados completos de la fase 1a/b anticipados en la primera mitad de 2025.
팔리세이드 바이오 (NASDAQ: PALI)는 PALI-2108의 1a/b 단계 연구에서 1a 부분을 성공적으로 완료했습니다. 이는 궤양성 대장염(UC) 치료제입니다. 연구는 다섯 개의 단일 용량 상승(SAD) 코호트, 네 개의 다중 용량 상승(MAD) 코호트, 그리고 음식 효과 교차를 포함했습니다.
예비 결과는 실험실 값이나 EKG와 관련된 중대한 부작용(SAE)이나 치료로 인한 부작용(TEAE) 없이 안전성이 유망하다는 데이터를 보여주었습니다. 여러 MAD 코호트(15mg-30mg BID)가 예상 치료 용량 범위 내에서 완료되었으며, 부작용은 최소한이었습니다. 하루 두 번 50mg의 가장 높은 용량 코호트에서만 한 명의 철회가 발생했습니다.
회사는 현재 1b 단계 UC 코호트를 위한 환자를 선별하고 용량을 투여하고 있으며, 한 명의 피험자가 이 부분을 완료했습니다. 1a 단계의 주요 데이터는 2025년 5월까지 예상되며, 1a/b 단계의 완전한 결과는 2025년 상반기에 발표될 예정입니다.
Palisade Bio (NASDAQ: PALI) a réussi à terminer la partie 1a de son étude de phase 1a/b pour PALI-2108, un traitement de la colite ulcéreuse (UC). L'étude comprenait cinq cohortes de doses ascendantes uniques (SAD), quatre cohortes de doses ascendantes multiples (MAD) et un croisement sur les effets des aliments.
Les résultats préliminaires ont montré des données de sécurité prometteuses, sans événements indésirables graves (SAE) ni événements indésirables émergents du traitement (TEAE) liés aux valeurs de laboratoire ou aux EKG. Plusieurs cohortes MAD (15mg-30mg BID) ont été complétées dans la plage de doses thérapeutiques attendue, avec des événements indésirables minimes. Un seul retrait a eu lieu dans la cohorte de dosage la plus élevée de 50mg deux fois par jour.
L'entreprise procède actuellement au dépistage et à la dose des patients pour la cohorte UC de phase 1b, un sujet ayant déjà complété cette partie. Les données préliminaires de la phase 1a sont attendues d'ici mai 2025, avec des résultats complets de la phase 1a/b prévus pour la première moitié de 2025.
Palisade Bio (NASDAQ: PALI) hat erfolgreich den Teil 1a seiner Phase 1a/b-Studie für PALI-2108, eine Behandlung für Colitis ulcerosa (UC), abgeschlossen. Die Studie umfasste fünf Einzel-Dosis-Steigerungs-(SAD)-Kohorten, vier Mehrfach-Dosis-Steigerungs-(MAD)-Kohorten und einen Crossover zu den Auswirkungen von Nahrung.
Vorläufige Ergebnisse zeigten vielversprechende Sicherheitsdaten ohne schwerwiegende unerwünschte Ereignisse (SAEs) oder behandlungsbedingte unerwünschte Ereignisse (TEAEs), die mit Laborwerten oder EKGs in Verbindung standen. Mehrere MAD-Kohorten (15mg-30mg BID) wurden im erwarteten therapeutischen Dosisbereich abgeschlossen, mit minimalen unerwünschten Ereignissen. Nur ein Rückzug trat in der höchsten Dosisgruppe von 50mg zweimal täglich auf.
Das Unternehmen führt derzeit das Screening und die Dosierung von Patienten für die Phase 1b UC-Kohorte durch, wobei ein Proband diesen Teil bereits abgeschlossen hat. Die wichtigsten Daten aus Phase 1a werden bis Mai 2025 erwartet, während die vollständigen Ergebnisse aus Phase 1a/b in der ersten Hälfte von 2025 erwartet werden.
- Strong safety profile with no serious adverse events in Phase 1a
- Successful completion of all SAD and MAD cohorts within therapeutic range
- High potency towards PDE4 B and D compared to other inhibitors
- Trial progression on schedule for topline data release
- Single patient withdrawal in highest dose cohort (50mg BID)
- Only one subject completed in Phase 1b portion so far
Insights
Palisade Bio's Phase 1a results for PALI-2108 represent encouraging progress in their UC program. The clean safety profile observed across multiple dosing cohorts is particularly noteworthy for a PDE4 inhibitor—a drug class historically challenged by tolerability issues that often limit therapeutic potential.
The completion of dosing in five SAD cohorts, four MAD cohorts, and the food effects crossover with minimal adverse events suggests PALI-2108 may have a differentiated profile. Most significant is the favorable tolerability at the 15-30mg BID dose range, which the company identifies as therapeutically relevant. The 15mg BID cohort showing no TEAEs and the titrated 30mg BID cohort reporting just a single mild TEAE are promising indicators.
From a development perspective, this safety milestone reduces the near-term clinical risk while enabling progression to the more critical Phase 1b portion in UC patients. The biomarker strategy incorporating hsCRP, fecal calprotectin, and tissue assessments is well-designed to provide early efficacy signals beyond safety data.
However, several cautions remain. This represents preliminary safety data only—not efficacy. The single withdrawal in the highest dose cohort suggests a potential ceiling to the dosing range. The true test awaits the Phase 1b results in actual UC patients, where both continued safety and initial efficacy signals will be critical for demonstrating proof-of-concept for this novel compound.
The completion of Phase 1a dosing for PALI-2108 represents a meaningful de-risking event for Palisade Bio's lead program. For a micro-cap company (
The favorable safety profile significantly increases the probability of successfully completing the Phase 1b portion in UC patients. PDE4 inhibitors have proven commercial value in inflammatory conditions, with approved products generating substantial revenue, but tolerability issues have historically their potential. If PALI-2108's preliminary tolerability advantage holds through later development, it could represent a competitive advantage in the crowded inflammatory bowel disease market.
The near-term catalyst of topline Phase 1a data expected by May 2025 provides a clear timeline for the next value inflection point. More importantly, the demonstration of tolerability at projected therapeutic doses reduces one significant development risk, though efficacy remains entirely unproven.
For investors, this incremental positive data strengthens Palisade's position heading into the more crucial Phase 1b portion. The inclusion of multiple biomarkers (hsCRP, calprotectin, tissue assessments) creates multiple opportunities for early efficacy signals. However, substantial development and financing risks remain at this early stage, despite this positive safety milestone.
Sustained positive preliminary data from all completed single ascending dose (SAD) cohorts, multiple ascending dose (MAD) cohorts, and food effects crossover, further supporting the safety and tolerability of PALI-2108
No serious adverse events (SAEs) or treatment-emergent adverse events (TEAEs) related to laboratory values or EKGs observed to date
Screening for Phase 1b UC cohort ongoing; On track to report topline data in the first half of 2025
Carlsbad, CA, April 09, 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 patients with autoimmune, inflammatory, and fibrotic diseases, today announced the completion of enrollment and dosing in all five Phase 1a SAD cohorts, all four MAD cohorts, and the food effects crossover in the Phase 1a portion of its ongoing Phase 1a/b study of PALI-2108 for the treatment of Ulcerative Colitis (UC).
Preliminary results show no SAEs and no TEAEs related to laboratory values or EKGs to date. The majority of observed TEAEs were considered mild, with only a single withdrawal in the highest 50 mg twice-daily dosage (BID) MAD cohort. Several of the MAD cohorts, ranging from 15 mg BID to 30 mg BID, were completed within the expected therapeutic dose range, again showing no SAEs or TEAEs related to laboratory values or EKGs. The 15 mg BID cohort was completed with no TEAEs, while the titrated 30 mg BID cohort was completed with a single mild TEAE. Given PALI-2108's high potency towards PDE4 B and D compared to other PDE4 inhibitors in preclinical studies, these results underscore its excellent tolerability at comparable dose levels. Screening and dosing of the Phase 1b UC patient cohort are ongoing, with one subject having completed this portion of the study. The Company is on track to report topline data from the Phase 1a portion of the study by the end of May 2025.
“We continue to make significant progress in our Phase 1a/b study of PALI-2108. With the completion of the Phase 1a portion and our ongoing efforts in screening, enrollment, and dosing within the Phase 1b cohort of UC patients, we remain on track to report topline data in the first half of 2025. Preliminary results from both our SAD and MAD cohorts support our confidence that we are dosing at the target therapeutic levels without encountering significant adverse events. This further strengthens our belief that PALI-2108 has the potential to offer a much-needed treatment option for patients with UC. We remain focused on the successful execution of the trial and look forward to sharing full topline data in the near future,” said Dr. Mitch Jones, Chief Medical Officer of Palisade.
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 will 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 the Company’s preclinical studies and preliminary data from 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 are the preliminary results of PALI-2108's Phase 1a trial for Ulcerative Colitis?
When will Palisade Bio (PALI) release the topline data for PALI-2108's Phase 1a/b trial?
What dosage levels were tested in PALI-2108's Multiple Ascending Dose (MAD) cohorts?
What biomarkers is PALI using to evaluate PALI-2108's effectiveness in UC patients?
