Palisade Bio Reports Positive PALI-2108 Phase 1b Clinical Data
Palisade Bio (NASDAQ:PALI) has reported positive Phase 1b clinical data for PALI-2108, its first-in-class, ileocolonic-targeted PDE4 B/D inhibitor for autoimmune and inflammatory diseases. The trial demonstrated 100% clinical response in ulcerative colitis (UC) patients, with 2 out of 5 patients achieving remission after just seven days.
Key findings include no serious adverse events in Phase 1a trials (n=84), and significant improvements in Phase 1b UC cohort (n=5) including a 62.8% mean reduction in modified Mayo score and approximately 70% reduction in fecal calprotectin. The study also showed normalization of 186 genes linked to fibrosis, supporting potential application in fibrostenotic Crohn's disease (FSCD).
The company plans to begin patient dosing for the Phase 1b FSCD study in 2H 2025, with Phase 2 IND submissions anticipated in 1H 2026.
Palisade Bio (NASDAQ:PALI) ha riportato dati clinici positivi di fase 1b per PALI-2108, il suo inibitore PDE4 B/D di prima classe mirato all’ileo-colon per malattie autoimmuni e infiammatorie. Lo studio ha mostrato risposta clinica del 100% nei pazienti con colite ulcerosa (UC), con 2 pazienti su 5 che hanno raggiunto la remissione dopo appena sette giorni.
Tra i risultati chiave figurano assenza di eventi avversi gravi nelle prove di fase 1a (n=84) e miglioramenti significativi nel gruppo UC di fase 1b (n=5) tra cui una riduzione media del 62,8% del punteggio Mayo modificato e circa riduzione del 70% della calprotectina fecale. lo studio ha inoltre mostrato la normalizzazione di 186 geni legati a fibrosi, supportando un potenziale impiego nella malattia di Crohn fibrostenotica (FSCD).
L’azienda prevede di iniziare la somministrazione ai pazienti per lo studio FSCD di fase 1b nella seconda metà del 2025, con presentazioni IND di fase 2 previste nella prima metà del 2026.
Palisade Bio (NASDAQ:PALI) ha reportado datos clínicos positivos de fase 1b para PALI-2108, su inhibidor PDE4 B/D de primera clase dirigido a la ileocólica para enfermedades autoinmunes e inflamatorias. El ensayo mostró una respuesta clínica del 100% en pacientes con colitis ulcerosa (UC), con 2 de 5 pacientes logrando remisión tras solo siete días.
Entre los hallazgos clave se encuentran la ausencia de eventos adversos graves en las pruebas de fase 1a (n=84) y mejoras significativas en la cohorte UC de la fase 1b (n=5), incluyendo una reducción media del 62,8% en la puntuación modificada de Mayo y aproximadamente una reducción del 70% de la calprotectina fecal. El estudio también mostró la normalización de 186 genes relacionados con la fibrosis, respaldando un posible uso en la enfermedad de Crohn fibroestenótica (FSCD).
La empresa planea comenzar la dosificación de pacientes para el estudio FSCD de fase 1b en la 2.ª mitad de 2025, con presentaciones IND de fase 2 anticipadas para la 1.ª mitad de 2026.
Palisade Bio (NASDAQ:PALI)가 PALI-2108에 대한 1상 1b 긍정적 데이터를 보고했습니다. 이는 자가면역 및 염증성 질환을 위한 ileocolon 표적 PDE4 B/D 억제제의 차세대 제형입니다. 이 시험은 궤양성 대장염(UC) 환자에서 임상 반응 100%을 보였으며, 7일 만에 remission에 도달한 환자가 5명 중 2명입니다.
핵심 발견으로는 1상 A에서 중대한 이상 반응 없음(n=84)과 1b UC 코호트(n=5)에서의 유의미한 개선이 있습니다. 여기에는 수정된 Mayo 점수의 평균 62.8% 감소와 대변 칼프로텍틴의 약 70% 감소가 포함됩니다. 연구는 또한 섬유화와 관련된 186개의 유전자 정상화가 나타났으며, FSCD(섬유화 Crohn병)에서의 잠재적 적용 가능성을 뒷받침합니다.
회사는 2025년 하반기에 FSCD 1b 연구의 환자 투여를 시작할 계획이며, Phase 2 IND 제출이 2026년 상반기에 예상됩니다.
Palisade Bio (NASDAQ:PALI) a annoncé des données cliniques positives de phase 1b pour le PALI-2108, son inhibiteur PDE4 B/D ciblé ileocolon, de nouvelle génération pour les maladies auto-immunes et inflammatoires. L’essai a montré une réponse clinique de 100% chez les patients atteints de colite ulcéreuse (UC), avec 2 sur 5 patients atteignant la rémission après seulement sept jours.
Parmi les résultats clés figurent Aucune événement indésirable grave dans les essais de phase 1a (n=84), et des améliorations significatives dans la cohorte UC de la phase 1b (n=5), incluant une réduction moyenne de 62,8% du score Mayo modifié et environ une réduction de 70% de la calprotectine fécale. L’étude a également montré la normalisation de 186 gènes liés à la fibrose, soutenant une application potentielle dans la maladie de Crohn fibro-sténosante (FSCD).
L’entreprise prévoit de commencer l’administration des patients pour l’étude FSCD de phase 1b au cours du second semestre 2025, avec des prévisions de soumissions IND de phase 2 au cours du premier semestre 2026.
Palisade Bio (NASDAQ:PALI) hat positive Phase-1b-Daten für PALI-2108 gemeldet, seinen erstklassigen, ileokolonalen PDE4 B/D-Hemmer für Autoimmun- und Entzündungserkrankungen. Die Studie zeigte eine 100%-ige klinische Ansprechrate bei Colitis ulcerosa (UC) mit 2 von 5 Patienten, die nach nur sieben Tagen in Remission gingen.
Zu den wichtigsten Befunden gehört kein schwerer unerwünschter Ereignisse in Phase-1a-Studien (n=84) sowie signifikante Verbesserungen in der Phase-1b-UC-Kohorte (n=5), einschließlich einer durchschnittlichen 62,8%-igen Reduktion des modifizierten Mayo-Scores und etwa 70%-Reduktion der fäkalen Calprotectin. Die Studie zeigte zudem die Normalisierung von 186 Genen, die mit Fibrose verbunden sind, was eine potenzielle Anwendung bei der fibrostenotischen Crohn-Krankheit (FSCD) unterstützt.
Das Unternehmen plant, die Verabreichung an Patienten für die Phase-1b-FSCD-Studie in der zweiten Hälfte von 2025 zu beginnen, mit Phase-2-IND-Einreichungen, die in der ersten Hälfte von 2026 erwartet werden.
Palisade Bio (NASDAQ:PALI) قد أبلغت عن بيانات علاجية إيجابية من المرحلة 1b لـ PALI-2108، مثبط PDE4 B/D من الطراز الأولي والمرمي إلى الأمعاء الدقيقة والقولون لأمراض مناعية والتهابية. أظهرت التجربة استجابة سريرية بنسبة 100% لدى مرضى القرح القرحية المعوية (UC)، حيث بلغ remission عند 2 من 5 مرضى بعد سبعة أيام فقط.
تشمل النتائج الرئيسية عدم وجود أحداث سلبية خطيرة في تجارب المرحلة 1a (عدد=84)، وتحسينات كبيرة في مجموعة UC من المرحلة 1b (n=5)، بما في ذلك خفض متوسط في درجة Mayo المعدلة بنسبة 62.8% وتقليل تقريبي بنسبة 70% في كال protecting الفالاتين.
أظهرت الدراسة أيضًا تطبيع 186 جينًا مرتبطًا بتليف الأنسجة، مما يدعم التطبيق المحتمل في مرض كرون fibrostenotic (FSCD).
تخطط الشركة لبدء إعطاء المرضى في دراسة FSCD من المرحلة 1b في النصف الثاني من 2025، مع توقع تقديم IND للمرحلة 2 في النصف الأول من 2026.
Palisade Bio (NASDAQ:PALI) 已公布其首创、靶向回肠结肠的 PDE4 B/D 抑制剂 PALI-2108 的 I 期 1b 临床数据，适用于自身免疫及炎症性疾病。试验显示对
UC 患者有 100% 的临床应答率，其中 5 例中有 2 例在七天后达到缓解。
主要发现包括在 I 期 1a 试验（n=84）中 未出现严重不良事件，以及 I 期 1b UC 队列（n=5）中的显著改善，包括 修改 Mayo 评分的平均下降 62.8% 和 粪便钙卫蛋白约下降 70%。研究还显示与纤维化相关的 186 个基因的正常化，支持其在纤维性克罗恩病（FSCD）中的潜在应用。
公司计划在 2025 年下半年开始 FSCD 1b 研究的患者给药，且预计在 2026 年上半年提交 Phase 2 的 IND。
- 100% clinical response rate in Phase 1b UC trial
- 40% of patients (2/5) achieved remission in just 7 days
- Strong safety profile with no serious adverse events in Phase 1a trials
- 62.8% mean reduction in modified Mayo score
- 70% reduction in inflammatory biomarker fecal calprotectin
- Normalization of 186 genes linked to fibrosis, supporting FSCD potential
- Small sample size in Phase 1b UC trial (only 5 patients)
- Study duration shorter than standard induction trials
- Phase 2 trials not expected to begin until 1H 2026
Insights
Palisade Bio's PALI-2108 shows promising early efficacy and safety in ulcerative colitis, with potential for Crohn's disease applications.
The Phase 1b data for PALI-2108, Palisade Bio's novel ileocolonic-targeted PDE4 B/D inhibitor, reveals a remarkably clean safety profile with no serious adverse events - crucial for chronic inflammatory bowel disease treatments where long-term safety is paramount. More striking is the 100% clinical response rate among the 5 ulcerative colitis patients, with 2 achieving clinical remission after just 7 days of treatment - an unusually rapid timeline for UC therapies.
The 62.8% mean reduction in modified Mayo score represents substantial symptomatic improvement, while the histological improvements (Nancy Index ↓58%, Robarts Index ↓56%) provide objective evidence of mucosal healing. The corresponding biomarker reductions, particularly the ~70% decrease in fecal calprotectin, validate these clinical observations at the molecular level.
What distinguishes this candidate is its dual mechanism targeting both inflammation and fibrosis. The normalization of 186 fibrosis-related genes suggests potential efficacy in fibrostenotic Crohn's disease (FSCD) - an indication with few effective non-surgical options. This positions PALI-2108 uniquely as both a potential best-in-class oral therapy for UC and possibly the first targeted anti-fibrotic therapy for Crohn's strictures.
While these results are promising, important context is that this was a small (n=5), short-duration study not powered for efficacy. The planned Phase 1b FSCD study and subsequent Phase 2 IND submissions in 2026 will be critical to validating these early signals.
PALI-2108 demonstrated favorable safety, with no serious adverse events, lab abnormalities, or EKG concerns
Phase 1b data demonstrated
Biomarker analyses showed normalization of 186 genes linked to fibrosis and Crohn’s disease strictures, supporting translational potential in fibrostenotic Crohn’s disease (FSCD)
Patient dosing in the Phase 1b FSCD study is expected to begin in 2H 2025; Phase 2 IND submissions anticipated in 1H 2026
Carlsbad, CA, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio,” or the “Company”), a clinical-stage biopharmaceutical company developing precision therapies for autoimmune, inflammatory, and fibrotic diseases, today announced new data from its ongoing clinical program evaluating PALI-2108, a first-in-class, ileocolonic-targeted PDE4 B/D inhibitor. The results are to be presented in an oral session at the STAR Consortium Annual Meeting – the accompanying slides are now available here.
The Phase 1b UC cohort demonstrated rapid and consistent clinical activity, with all patients responding to treatment. While the study was shorter in duration than standard induction trials and not powered for efficacy, there was promising signals of clinical improvement, with 2 of 5 patients achieving remission after only seven days. These improvements were reinforced by favorable histology and biomarker changes that confirmed local PDE4 engagement and broad immunologic resolution. Together with the strong safety and PK profile observed in the Phase 1a study, the results highlight PALI-2108’s differentiated potential as both an anti-inflammatory and anti-fibrotic therapy.
“These results highlight the differentiated profile of PALI-2108, demonstrating strong safety, rapid clinical activity, and broad biomarker engagement in ulcerative colitis, while reinforcing its potential as the first targeted anti-fibrotic therapy in Crohn’s strictures,” said JD Finley, Chief Executive Officer of Palisade Bio. “We are excited to advance this program into its next stage of development as we prepare for Phase 2.”
Key Clinical Findings
Phase 1a Safety and Pharmacokinetics (n=84, SAD/MAD)
- No serious adverse events (SAEs) and no lab or EKG abnormalities observed.
- Well tolerated at single doses up to 450 mg and multiple BID doses up to 50 mg.
- Extended half-life and colon-targeted bioactivation support once-daily dosing.
Phase 1b Ulcerative Colitis (UC) Cohort (n=5, 7 days)
- All patients (5/5 patients) showed a clinical response as measured by modified Mayo score
- Two of the 5 patients achieved clinical remission based on FDA-defined endpoints
62.8% mean reduction in modified Mayo score (~4-point absolute decrease)- Histologic improvements: Nancy Index ↓
58% , Robarts Index ↓56% , Geboes Score ↓36% - Inflammatory biomarkers reduced: fecal calprotectin ↓~
70% , hsCRP ↓~15% - Mechanistic biomarkers improved: colon tissue cAMP ↑~
27% , tissue lymphocytes ↓~29% , tissue PDE4B ↓~71%
Translational Relevance to FSCD
- 186 fibrotic gene markers elevated at baseline in UC patients were reduced at endpoint.
- Data support anti-fibrotic potential of PALI-2108 in FSCD.
Dr. Mitchell Jones, Chief Medical Officer, added, “What stands out is the consistency across clinical, histologic and mechanistic readouts in UC. The rapid clinical responses and biomarker improvements we observed support PALI-2108’s targeted engagement of PDE4 biology and reinforce its potential to become a best-in-class oral therapy for UC. Importantly, the same mechanistic pathways also support anti-fibrotic activity, which we believe extends the opportunity into FSCD. By advancing UC as our lead indication, we are prioritizing a clear regulatory and clinical path while maintaining the broader potential of this program.”
For more information about the Phase 1a/b clinical study, visit clinicaltrials.gov and reference identifier NCT06663605. Data from the planned Phase 1b FSCD study, together with results from Palisade’s completed Phase 1a/1b trials in UC, will support the Company’s planned Phase 2 IND submissions to the U.S. Food and Drug Administration (FDA) in the first half of 2026.
About PALI-2108
PALI-2108 is an orally administered prodrug engineered for gut-restricted delivery of PDE4 B/D inhibition to the terminal ileum and colon. Activated by bacterial enzymes in the lower intestine, PALI-2108 achieves high local tissue concentrations while minimizing systemic exposure. This design aims to maximize anti-inflammatory and anti-fibrotic effects while reducing class-related tolerability issues such as nausea and headache that have historically limited systemic PDE4 inhibitors.
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, clinical response and clinical efficacy rates and dosing requirements of PALI-2108 based on the Company’s preclinical studies and data from its Phase 1a/b clinical study; indications and anticipated benefits of PALI-2108, including the potential of PALI-2108 to treat FSCD; and the expected timing of the Company’s planned Phase 1b clinical study of PALI-2108 for the treatment of FSCD and the planned Phase 2 clinical study of PALI-2108 for the treatment of UC. These forward-looking statements are based on the Company’s current expectations. Forward-looking statements involve risks and uncertainties. Important factors that could cause actual results to differ materially from those reflected in the Company’s forward-looking statements include, among others, the timing of enrollment, commencement and completion of the Company’s clinical trials; the Company’s reliance on PALI-2108, and its early stage of clinical development; the risk that prior results, such as signals of safety, clinical response, clinical efficacy, activity, dosing or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving the Company’s product candidates in clinical trials focused on the same or different indications; the Company’s ability to secure additional financing to fund future operations and development of its product candidates; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 24, 2025, 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
Source: Palisade Bio
FAQ
What were the key results of PALI-2108's Phase 1b trial for ulcerative colitis?
Is PALI-2108 safe based on the clinical trial results?
When will Palisade Bio (PALI) begin Phase 2 trials for PALI-2108?
What makes PALI-2108 different from other UC treatments?
What is the potential impact of PALI-2108 for Crohn's disease treatment?
