Palisade Bio Appoints Sharon Skare as Vice President, Global Head of Clinical Operations
Palisade Bio (NASDAQ: PALI) appointed Sharon Skare as Vice President, Global Head of Clinical Operations on Oct 28, 2025. Ms. Skare brings over 24 years of global clinical development and operations experience across autoimmune, metabolic, gastrointestinal, and fibrotic diseases.
The company is advancing PALI-2108, an orally administered, gut‑restricted prodrug designed to release a PDE4 inhibitor in the terminal ileum and colon. Palisade completed a Phase 1a/1b study with positive data, is conducting a Phase 1b study in fibrostenotic Crohn’s disease, and plans to submit Phase 2 INDs to the FDA in H1 2026. Management expects Skare’s experience in IBD operations and inspection readiness to support clinical and regulatory execution.
Palisade Bio (NASDAQ: PALI) ha nominato Sharon Skare vicepresidente, Responsabile globale delle Operazioni Cliniche il 28 ottobre 2025. La signora Skare porta oltre 24 anni di esperienza globale nello sviluppo clinico e nelle operazioni in aree quali malattie autoimmuni, metaboliche, gastrointestinali e fibrotiche.
L'azienda sta avanzando con PALI-2108, un prodrug somministrato per via orale, limitato all'intestino, progettato per rilasciare un inibitore PDE4 nell'ileo terminale e nel colon. Palisade ha completato uno studio Phase 1a/1b con dati positivi, sta conducendo uno studio di fase 1b in malattia di Crohn fibrostenotica e prevede di presentare IND di Fase 2 alla FDA nel primo semestre del 2026. Il management si aspetta che l'esperienza di Skare nelle operazioni IBD e nella prontezza per ispezioni sostenga l'esecuzione clinica e regolatoria.
Palisade Bio (NASDAQ: PALI) designó a Sharon Skare como Vicepresidenta, Jefa Global de Operaciones Clínicas, el 28 de octubre de 2025. La Sra. Skare aporta más de 24 años de experiencia global en desarrollo clínico y operaciones en enfermedades autoinmunes, metabólicas, gastrointestinales y fibrosas.
La compañía está avanzando con PALI-2108, un profármaco administrado por vía oral y limitado al intestino, diseñado para liberar un inhibidor de PDE4 en el íleon terminal y el colon. Palisade completó un estudio fase 1a/1b con datos positivos, está llevando a cabo un estudio de fase 1b en enfermedad de Crohn fibroestenótica y planea presentar IND de Fase 2 a la FDA en la primera mitad de 2026. La Dirección espera que la experiencia de Skare en operaciones de EII y en la preparación para inspecciones respalde la ejecución clínica y regulatoria.
Palisade Bio (NASDAQ: PALI)는 2025년 10월 28일 Sharon Skare를 글로벌 임상 운영 부사장 겸 수석으로 임명했습니다. Skare 씨는 자가면역 질환, 대사성 질환, 위장관 질환 및 섬유화 질환에 걸친 글로벌 임상 개발 및 운영 경험이 24년 이상 있습니다.
회사는 경구 투여로 장에 국한된 프루그(prodrug)인 PALI-2108을 진행 중이며 말단 회장 및 결장에서 PDE4 억제제를 방출하도록 설계되었습니다. Palisade는 1a/1b 단계 연구를 긍정적인 데이터로 완료했고 섬유화 Crohn 병의 1b 단계 연구를 수행 중이며, 2026년 상반기에 FDA에 2상 IND를 제출할 계획입니다. 경영진은 IBD 운용 및 검사 준비에 대한 Skare의 경험이 임상 및 규제 실행을 뒷받침할 것으로 기대합니다.
Palisade Bio (NASDAQ: PALI) a nommé Sharon Skare au poste de vice-présidente, Directrice mondiale des Opérations Cliniques, le 28 octobre 2025. Mme Skare apporte plus de 24 ans d’expérience mondiale en développement clinique et opérations dans les domaines des maladies auto-immunes, métaboliques, gastro-intestinales et fibrosantes.
L’entreprise fait progresser PALI-2108, un prodrogues administré par voie orale et restreint à l’intestin, conçu pour libérer un inhibiteur PDE4 dans l’iléon terminal et le côlon. Palisade a complété une étude Phase 1a/1b avec des résultats positifs, mène une étude de phase 1b chez la maladie de Crohn fibro-sténosante et prévoit de soumettre des IND de Phase 2 à la FDA au 1er semestre 2026. La direction s’attend à ce que l’expérience de Skare dans les opérations sur les maladies inflammatoires de l’intestin et la préparation aux inspections soutiennent l’exécution clinique et réglementaire.
Palisade Bio (NASDAQ: PALI) hat am 28. Oktober 2025 Sharon Skare zur Vizepräsidentin, Global Head of Clinical Operations, ernannt. Frau Skare bringt über 24 Jahre globale Erfahrung in der klinischen Entwicklung und im operativen Bereich in Autoimmun-, Stoffwechsel-, Gastrointestinal- und fibrotischen Erkrankungen mit.
Das Unternehmen treibt PALI-2108 voran, ein oral verabreichtes, intestinale Prodrug, das darauf ausgelegt ist, einen PDE4-Hemmer im terminalen Ileum und Dickdarm freizusetzen. Palisade schloss eine Phase 1a/1b-Studie mit positiven Daten ab, führt eine Phase-1b-Studie bei fibrostenotischer Crohn-Krankheit durch und plant, Phase-2-INDs bei der FDA im ersten Halbjahr 2026 einzureichen. Das Management erwartet, dass Skares Erfahrung in IBD-Operationen und Inspektionsbereitschaft die klinische und regulatorische Umsetzung unterstützt.
Palisade Bio (NASDAQ: PALI) عيّنت شيرون سكار نائب رئيس تنفيذي ورئيسة قسم العمليات السريرية العالمية في 28 أكتوبر 2025. تتمتّع السيدة سكار بخبرة عالمية تزيد عن 24 عامًا في تطوير وعمليات سريرية عبر أمراض المناعة الذاتية، والتمثيل الغذائي، والجهاز الهضمي، والأمراض الليفية.
تواصل الشركة تقدمها في PALI-2108، وهو دواء پرو-دوغان فموي مقيد بالأمعاء، مصمم لإطلاق مثبط PDE4 في ileum terminal والقولون. أكملت Palisade دراسة المرحلة 1a/1b بنتائج إيجابية، وتجري حالياً دراسة المرحلة 1b في مرض كرون التليفامي وتخطط لتقديم IND من المرحلة 2 إلى إدارة الغذاء والدواء الأمريكية في النصف الأول من 2026. يتوقع الإدارة أن دعم خبرة سكار في عمليات مرضى الالتهاب المعوي وجاهزية التفتيش يساندان التنفيذ السريري والتنظيمي.
Palisade Bio（纳斯达克股票代码：PALI） 于 2025 年 10 月 28 日任命 Sharon Skare 为全球临床运营副总裁。Skare 女士在全球范围内的免疫性疾病、代谢、胃肠疾病和纤维化疾病的临床开发与运营方面拥有超过 24 年 的经验。
公司正在推进 PALI-2108，一种口服、限于肠道的前药，设计在末端回肠和结肠释放 PDE4 抑制剂。Palisade 已完成具有积极数据的 1a/1b 期 研究，正在开展针对纤维化 Crohn 病的 1b 期研究，并计划在 2026 年上半年向 FDA 提交 2 期 IND。管理层预计 Skare 在 IBD 运营和审 inspect 准备方面的经验将支持临床和监管执行。
- Appointment of Sharon Skare with >24 years clinical operations experience
- Completed Phase 1a/1b study of PALI-2108 with reported positive data
- Active Phase 1b study in fibrostenotic Crohn’s disease underway
- Planned Phase 2 IND submissions to FDA in H1 2026
- PALI-2108 remains pre-Phase 2; no Phase 2 efficacy data yet
- PDE4 inhibitors have historically faced class-related tolerability issues
Seasoned Pharmaceutical leader bringing over 24 years of experience in clinical development across autoimmune, metabolic, cardiovascular, and gastrointestinal indications
Company remains focused on advancing PALI-2108 in ulcerative colitis and fibrostenotic Crohn’s disease, with Phase 2 IND submission planned for H1 2026
Carlsbad, CA, Oct. 28, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a clinical-stage biopharmaceutical company developing precision therapies for autoimmune, inflammatory, and fibrotic diseases, today announced the appointment of Sharon Skare, PhD(c) as Vice President, Global Head of Clinical Operations.
Ms. Skare brings more than 24 years of leadership experience in global clinical development and operations across large and emerging biotechnology companies. Her expertise spans autoimmune, metabolic, gastrointestinal, and fibrotic diseases, with a track record of successfully delivering programs from early development through regulatory approval, commercialization, and post-marketing submissions. She has served seven years as a department head within Clinical Operations and has been instrumental in multiple global inspection-readiness initiatives and post-approval filings for therapies in ulcerative colitis and diabetes.
“We are thrilled to welcome Sharon to Palisade Bio,” said Dr. Mitchell Jones, MD, PhD, Chief Medical Officer of Palisade Bio. “Her extensive experience leading global clinical operations in IBD and her proven success guiding programs through pivotal phases and inspections will be invaluable as we advance PALI-2108 into our planned Phase 2 studies. Sharon’s leadership will strengthen our operational infrastructure and accelerate our progress toward key clinical and regulatory milestones.”
“I’m excited to join Palisade at this pivotal stage in its evolution,” said Ms. Skare. “With ulcerative colitis and fibrostenotic Crohn’s disease affecting millions worldwide, there remains a pressing need for new therapies that combine efficacy with tolerability. The growing body of data for PALI-2108 and its targeted oral delivery profile represent an exciting opportunity to redefine treatment for patients with IBD. I look forward to leveraging my global operations experience to drive executional excellence and help realize the full potential of this first-in-class program.”
Ms. Skare most recently served as Vice President and Global Head of Clinical Operations at Abivax, where she oversaw global Phase 3 and Phase 2 programs in ulcerative colitis and Crohn’s disease. Previously, Ms. Skare held senior leadership positions at Pfizer and Arena Pharmaceuticals, where she led the global clinical operations program for Etrasimod, an oral, selective S1P receptor modulator for ulcerative colitis, now approved as Velsipity™. She earned Pfizer’s Craig A. Saxton Clinical Development Excellence Award and 12 additional company recognitions for clinical development excellence and operational leadership. Sharon served as head of clinical operations at Elcelyx Therapeutics, advancing a delayed-release metformin formulation for Type 2 diabetes from proof of concept through End-of-Phase 2 alignment with the FDA. Early in her career Ms. Skare was part of the core clinical operations and clinical science teams at Amylin Pharmaceuticals through the development and approval of Byetta®, the first GLP-1 agonist, and Symlin®, the first non-insulin treatment indicated for Type 1 diabetes. She also held clinical research roles at PPD and Clinimetrics Research Associates.
Palisade Bio is currently advancing PALI-2108, an orally administered, prodrug engineered for local delivery of phosphodiesterase-4 (PDE4) inhibition to the terminal ileum and colon. The prodrug molecule is designed to be gut-restricted and pharmacologically inactive until it reaches the lower intestine, where it is cleaved by bacterial enzymes to release its active PDE4 inhibitor metabolite directly at the site of inflammation and fibrosis. This targeted and slow-release design is intended to prevent absorption through the upper gut, achieve sustained local exposure and a longer half-life that enables once-daily dosing, and is engineered to produce a blunted peak plasma concentration to improve the overall therapeutic index. Together, these properties are intended to maximize anti-inflammatory and anti-fibrotic effects while minimizing systemic exposure and reducing class-related tolerability issues, such as nausea and headache, that have limited systemic PDE4 inhibitors.
The Company recently completed a Phase 1a/1b study of PALI-2108 for ulcerative colitis (UC) and reported positive data (clinicaltrials.gov NCT06663605). A Phase 1b study of PALI-2108 is currently underway for the treatment of fibrostenotic Crohn’s disease (FSCD). Data from studies are expected to support Phase 2 Investigational New Drug (IND) submissions to the U.S. Food and Drug Administration (FDA) in the first half of 2026.
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 and results of clinical trials, the potential mechanisms of action and therapeutic benefits of PALI-2108, 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
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