Palisade Bio Granted Canadian Patent Covering Composition of Lead Product Candidate PALI-2108
Palisade Bio (Nasdaq: PALI) announced that the Canadian Intellectual Property Office granted patent No. 3,174,137 for PALI-2108, titled “Gut Microbiota Bioactivated PDE4 Inhibitor Precursors,” providing composition-of-matter protection through May 28, 2041. PALI-2108 is an orally administered, ileocolonic-targeted PDE4 B/D inhibitor designed for fibrostenotic Crohn’s disease (FSCD) and ulcerative colitis (UC). The molecule uses a galactose-derived sugar moiety activated by colonic β-glucuronidase to enable colon-specific distribution with reduced systemic exposure, as shown in a tissue distribution study. Patient dosing in the Phase 1b FSCD study was expected in H2 2025, topline data expected in Q1 2026, and a planned Phase 2 IND submission to FDA is targeted for H1 2026.
Palisade Bio (Nasdaq: PALI) ha annunciato che l'Ufficio Canadese per la Proprietà Intellettuale ha concesso la brevetto n. 3,174,137 per PALI-2108, intitolato “Precursor bioattivati dall' microbiota intestinale dell'inibitore PDE4”, fornendo protezione della materia fino al 28 maggio 2041. PALI-2108 è un inibitore PDE4 B/D somministrato per via orale e mirato all'ileo-colon (target ileocolon) per la malattia di Crohn fibrostenotica (FSCD) e la colite ulcerosa (UC). La molecola utilizza una porzione zuccherina derivata dal galattosio attivata dalla β-glucuronidasi colonica per consentire una distribuzione specifica al colon con esposizione sistemica ridotta, come mostrato in uno studio di distribuzione tissutale. La somministrazione ai pazienti nello studio di Fase 1b FSCD era prevista nella seconda metà del 2025, i dati principali previsti nel primo trimestre del 2026, e l'invio pianificato dell'IND di Fase 2 alla FDA è mirato per la prima metà del 2026.
Palisade Bio (Nasdaq: PALI) anunció que la Oficina de Propiedad Intelectual de Canadá concedió la patente n.º 3,174,137 para PALI-2108, titulada “Precursores inhibidores PDE4 bioactivados por la microbiota intestinal”, que protege la materia hasta el 28 de mayo de 2041. PALI-2108 es un inhibidor PDE4 B/D administrado por vía oral y dirigido al íleon y colon (objetivo ilio-colónico) para la enfermedad de Crohn fibroestenótica (FSCD) y la colitis ulcerosa (UC). La molécula utiliza una porción de azúcares derivada de la galactosa activada por la β-glucuronidasa colónica para permitir una distribución específica en el colon con menor exposición sistémica, como se muestra en un estudio de distribución tisular. La dosificación de pacientes en el estudio de Fase 1b FSCD estaba prevista para la segunda mitad de 2025, los datos principales se esperan para el primer trimestre de 2026, y se tiene previsto presentar la IND de Fase 2 a la FDA para el primer semestre de 2026.
Palisade Bio (Nasdaq: PALI)가 캐나다 지적재산권청이 PALI-2108에 대해 특허 번호 3,174,137를 부여했다고 발표했습니다. 제목은 “장 미생물군 바이오활성화 PDE4 억제제 전구체”이며, 물질 구성에 대한 보호는 2041년 5월 28일까지 제공합니다. PALI-2108은 경구 투여, 회장-대장 표적 PDE4 B/D 억제제로 설계되어 섬유협착성 크론병(FSCD) 및 궤양성 대장염(UC)을 대상으로 합니다. 이 분자는 갈락토스 계열 당 잔기를 대장 β-글루쿠로니다아제에 의해 활성화시켜 대장 특이적 분포를 가능하게 하고 전신 노출을 감소시키는 것으로 조직 분포 연구에서 입증되었습니다. FSCD 1상 2상 연구의 환자 투여는 2025년 하반기에 예상되었고, 주요 데이터는 2026년 1분기에 기대되며, 2상 IND를 FDA에 제출하는 계획은 2026년 상반기에 목표로 하고 있습니다.
Palisade Bio (NASDAQ : PALI) a annoncé que l’Office de la propriété intellectuelle du Canada a accordé le brevet n° 3,174,137 pour PALI-2108, intitulé “Précurseurs bioactivés par la microbiote intestinale d’inhibiteurs PDE4”, fournissant une protection de la matière jusqu’au 28 mai 2041. PALI-2108 est un inhibiteur PDE4 B/D administré par voie orale et ciblant l’iléocolon (objectif iléocôlon) pour la maladie de Crohn fibro-sténotique (FSCD) et la colite ulcéro-inflammatoire (CU). La molécule utilise une portion sucrée dérivée du galactose activée par la β-glucuronidase colique, permettant une distribution spécifique au colon avec une exposition systémique réduite, comme démontré dans une étude de distribution tissulaire. L’administration chez les patients dans l’étude de phase 1b FSCD était prévu pour la deuxième moitié de 2025, les données opérationnelles étant attendues pour le premier trimestre de 2026, et l’envoi prévu de l IND de la phase 2 à la FDA est visé pour le premier semestre de 2026.
Palisade Bio (Nasdaq: PALI) teilte mit, dass das Canadian Intellectual Property Office das Patent Nr. 3,174,137 für PALI-2108 erteilt hat, mit dem Titel „Gut Microbiota Bioactivated PDE4 Inhibitor Precursors“ und Schutz der Stoffzusammensetzung bis zum 28. Mai 2041 gewährt wird. PALI-2108 ist ein oral verabreichtes PDE4 B/D-Hemmer, der auf das ileokolonale Zielgebiet abzielt und für die fibrotische Crohn-Krankheit (FSCD) und Colitis ulcerosa (UC) entwickelt wurde. Das Molekül verwendet eine galaktoseabgeleitete Zuckereinheit, die durch die kolonisierte β-Glucuronidase aktiviert wird, um eine kolonspezifische Verteilung bei reduzierter systemischer Exposition zu ermöglichen, wie in einer Gewebeverteilungsstudie gezeigt. Die Dosierung der Patienten in der Phase-1b FSCD-Studie war für die 2. Hälfte 2025 vorgesehen, die Topline-Daten werden für das 1. Quartal 2026 erwartet, und der geplante Phase-2-IND-Einreichung bei der FDA ist auf die erste Hälfte 2026 ausgerichtet.
Palisade Bio (بورصة ناسداك: PALI) أعلنت أن مكتب الملكية الفكرية الكندي منح براءة الاختراع رقم 3,174,137 لـ PALI-2108، بعنوان “مسببات PDE4 النشطة بيولوجياً بواسطة ميكروبيوتا الأمعاء”، مما يوفر حماية للمادة حتى 28 مايو/أيار 2041. PALI-2108 هو مثبط PDE4 B/D يُعطى عن طريق الفم ومصمم لاستهداف النهاية ileocolon (الإيليوكولون) لمرض كرون المصاحب بتصلب الأمعاء (FSCD) والتهاب القولون التقرحي (UC). الجزيء يستخدم جزء سكري مشتق من الغالاكتوز مُفَعّل بواسطة β-glucuronidase القالونيّة ليتيح توزيعاً خاصاً في القولون مع انخفاض التعرض الجهازي، كما يظهر في دراسة توزيعه النسيجي. من المتوقع إعطاء المرضى في دراسة المرحلة 1b FSCD في النصف الثاني من 2025، والمتوقع أن تكون البيانات الأولية في الربع الأول من 2026، وتستهدف معالجة التقديم لـ IND للمرحلة 2 لدى FDA في النصف الأول من 2026.
Palisade Bio（纳斯达克：PALI） 宣布，加拿大知识产权办公室已授予专利号 3,174,137，涵盖 PALI-2108，标题为“肠道微生物群生物活化的 PDE4 抑制剂前体”，对物质组成的保护有效期至 2041 年 5 月 28 日。PALI-2108 是一种口服给药、靶向回肠-结肠的 PDE4 B/D 抑制剂，设计用于纤维性狭窄型克罗恩病（FSCD）和溃疡性结肠炎（UC）。该分子使用源自半乳糖的糖基，经肠道β-葡萄糖醛酸酶活化，以实现对结肠的特异性分布并降低全身暴露，如组织分布研究所示。FSCD 1b 研究的患者给药预计在 2025 年下半年，初步数据预计在 2026 年第一季度，计划在 2026 年上半年向 FDA 提交第二阶段的 IND。
- Patent protection secured through May 28, 2041
- Colon-targeted design via galactose-derived prodrug moiety
- Reduced systemic exposure demonstrated in tissue distribution study
- Phase 1b dosing for FSCD expected in H2 2025
- Efficacy and safety in FSCD not yet demonstrated in Phase 1b
- Topline clinical data not expected until Q1 2026
Insights
Grant of a Canadian composition patent strengthens exclusivity for PALI-2108 through
The patent gives Palisade Bio composition-of-matter protection in Canada for PALI-2108, which materially secures control of the molecule's core chemical identity in that jurisdiction. Composition claims are the strongest form of IP for small molecules because they block rivals from making the same active entity rather than only narrower formulation or use claims.
Key dependencies and risks include the geographic scope (Canada only), enforceability against any future analogs, and the remaining global patent estate not disclosed here; the patent term to
PALI-2108 advances clinically while IP protection now covers Canadian composition rights; dosing in Phase 1b expected in
PALI-2108 is described as an ileocolonic-targeted PDE4 B/D inhibitor designed for FSCD and UC using a galactose-derived prodrug activated by β-glucuronidase, with tissue distribution data cited to show localized activation and reduced systemic exposure. The clinical path shown includes Phase 1b patient dosing expected in
Dependencies and risks are the unknowns in clinical safety, efficacy, and regulatory review that are not detailed here; the press release gives timelines but no outcome data. Monitor the
PALI-2108 is the first and only PDE4 inhibitor designed to target terminal ileum and colon for fibrostenotic Crohn’s disease (FSCD) and ulcerative colitis (UC) to address significant unmet medical needs
Carlsbad, CA, Oct. 13, 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 that the Canadian Intellectual Property Office (CIPO) has granted patent number 3,174,137 titled, “Gut Microbiota Bioactivated PDE4 Inhibitor Precursors.” The patent covers the composition of PALI-2108, the Company’s orally administered, first-in-class, ileocolonic-targeted PDE4 B/D inhibitor in development for the treatment of FSCD and UC.
J.D. Finley, Chief Executive Officer of Palisade commented, “We remain committed to strengthening the intellectual property portfolio around PALI-2108 and are focused on advancing the development of this program. The granting of this patent marks an important addition to our global IP portfolio estate . Our team continues to execute on our clinical milestones, and we look forward to pursuing the full therapeutic promise of PALI-2108 to treat patients with FSCD and UC.”
The patent provides composition-of-matter protection for PALI-2108 through May 28, 2041. PALI-2108’s unique design incorporates a galactose-derived sugar moiety that allows for minimal absorption until converted by the colonic bacterium enzyme β-glucuronidase. This mechanism is intended to ensure localized bioactivation, leading to colon-specific distribution with reduced systemic exposure, as demonstrated in a tissue distribution study.
Palisade Bio continues to advance the development of PALI-2108 in its Phase 1b FSCD study with patient dosing expected to commence in H2 2025 and topline data expected in Q1 2026. Data from the FSCD Phase 1b, together with results from Palisade’s completed Phase 1a/1b trials in UC, will support the Company’s planned Phase 2 IND submission 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 timing of clinical trials, the potential therapeutic benefits of PALI-2108, the expected duration and scope of patent protection, and plans for regulatory submissions. 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, 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; 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 does Palisade Bio's Canadian patent for PALI-2108 cover and how long does it last?
How does PALI-2108 achieve colon-specific activation for PALI (Nasdaq: PALI)?
When will Palisade Bio start dosing patients in the Phase 1b FSCD study for PALI-2108?
When does Palisade Bio expect topline data from the PALI-2108 FSCD study?
What regulatory milestone does Palisade plan for PALI-2108 in 2026?
