Palisade Bio Commences Dosing in First Ulcerative Colitis Patient Cohort in Ongoing Phase 1a/b Study of PALI-2108
Palisade Bio (NASDAQ: PALI) has initiated dosing in the first Ulcerative Colitis (UC) patient cohort of its ongoing Phase 1a/b study for PALI-2108. The company has completed five single ascending dose (SAD) cohorts and three of four multiple ascending dose (MAD) cohorts, with promising preliminary safety data.
Key highlights include:
- No serious adverse events (SAEs) or treatment-emergent adverse events (TEAEs) related to laboratory values or EKGs
- Majority of TEAEs were mild, with only one withdrawal at highest MAD dose
- Two MAD cohorts completed within expected therapeutic range showed excellent tolerability
The study aims to evaluate safety, tolerability, and pharmacokinetics in both healthy volunteers and UC patients. The trial will analyze various biomarkers including hsCRP, fecal calprotectin, and colonic tissue histological assessments. Topline data is expected in the first half of 2025.
Palisade Bio (NASDAQ: PALI) ha avviato la somministrazione nel primo gruppo di pazienti con Colite Ulcerosa (UC) del suo studio in corso di Fase 1a/b per PALI-2108. L'azienda ha completato cinque coorti di dose singola ascendente (SAD) e tre delle quattro coorti di dose multipla ascendente (MAD), con dati preliminari di sicurezza promettenti.
Tra i punti salienti:
- Nessun evento avverso grave (SAE) o evento avverso emergente dal trattamento (TEAE) correlato a valori di laboratorio o EKG
- La maggior parte dei TEAE è stata lieve, con solo un ritiro alla dose più alta di MAD
- Due coorti di MAD completate all'interno dell'intervallo terapeutico previsto hanno mostrato un'ottima tollerabilità
Lo studio mira a valutare la sicurezza, la tollerabilità e la farmacocinetica sia in volontari sani che in pazienti con UC. La sperimentazione analizzerà vari biomarcatori, tra cui hsCRP, calprotectina fecale e valutazioni istologiche del tessuto colico. I dati principali sono attesi nella prima metà del 2025.
Palisade Bio (NASDAQ: PALI) ha iniciado la dosificación en la primera cohorte de pacientes con Colitis Ulcerosa (UC) de su estudio en curso de Fase 1a/b para PALI-2108. La compañía ha completado cinco cohortes de dosis única ascendente (SAD) y tres de cuatro cohortes de dosis múltiple ascendente (MAD), con datos preliminares de seguridad prometedores.
Los aspectos destacados incluyen:
- No se reportaron eventos adversos graves (SAE) ni eventos adversos emergentes del tratamiento (TEAE) relacionados con valores de laboratorio o EKG
- La mayoría de los TEAE fueron leves, con solo una retirada en la dosis más alta de MAD
- Dos cohortes de MAD completadas dentro del rango terapéutico esperado mostraron una excelente tolerabilidad
El estudio tiene como objetivo evaluar la seguridad, la tolerabilidad y la farmacocinética tanto en voluntarios sanos como en pacientes con UC. El ensayo analizará varios biomarcadores, incluidos hsCRP, calprotectina fecal y evaluaciones histológicas del tejido colónico. Se esperan los datos principales en la primera mitad de 2025.
팔리세이드 바이오 (NASDAQ: PALI)는 현재 진행 중인 PALI-2108의 1상/2상 연구에서 첫 번째 궤양성 대장염(UC) 환자 집단에 대한 투약을 시작했습니다. 이 회사는 다섯 개의 단일 용량 상승(SAD) 집단과 네 개의 다중 용량 상승(MAD) 집단 중 세 개를 완료했으며, 유망한 초기 안전성 데이터를 확보했습니다.
주요 사항은 다음과 같습니다:
- 실험실 수치나 EKG와 관련된 심각한 이상 반응(SAE) 또는 치료 유발 이상 반응(TEAE)이 없음
- 대부분의 TEAE는 경미했으며, 가장 높은 MAD 용량에서 단 한 건의 철회만 발생함
- 예상 치료 범위 내에서 완료된 두 개의 MAD 집단이 우수한 내약성을 보임
이 연구는 건강한 자원봉사자와 UC 환자 모두에서 안전성, 내약성 및 약물 동태학을 평가하는 것을 목표로 합니다. 시험은 hsCRP, 대변 칼프로텍틴 및 대장 조직의 조직학적 평가를 포함한 다양한 바이오마커를 분석할 것입니다. 주요 데이터는 2025년 상반기에 발표될 예정입니다.
Palisade Bio (NASDAQ: PALI) a commencé à administrer des doses dans la première cohorte de patients atteints de colite ulcéreuse (UC) de son étude en cours de phase 1a/b pour PALI-2108. L'entreprise a complété cinq cohortes de dose unique ascendante (SAD) et trois des quatre cohortes de dose multiple ascendante (MAD), avec des données préliminaires de sécurité prometteuses.
Les points clés incluent :
- Aucun événement indésirable grave (SAE) ou événement indésirable émergent du traitement (TEAE) lié aux valeurs de laboratoire ou aux EKG
- La majorité des TEAE étaient légers, avec seulement un retrait à la dose MAD la plus élevée
- Deux cohortes de MAD complétées dans la plage thérapeutique attendue ont montré une excellente tolérance
L'étude vise à évaluer la sécurité, la tolérance et la pharmacocinétique tant chez des volontaires sains que chez des patients atteints de UC. L'essai analysera divers biomarqueurs, y compris hsCRP, la calprotectine fécale et les évaluations histologiques des tissus coliques. Les données principales sont attendues dans la première moitié de 2025.
Palisade Bio (NASDAQ: PALI) hat die Dosierung in der ersten Kohorte von Patienten mit Colitis ulcerosa (UC) in seiner laufenden Phase 1a/b-Studie für PALI-2108 begonnen. Das Unternehmen hat fünf Kohorten mit einer einzelnen aufsteigenden Dosis (SAD) und drei von vier Kohorten mit einer mehrfach aufsteigenden Dosis (MAD) abgeschlossen, mit vielversprechenden vorläufigen Sicherheitsdaten.
Wichtige Highlights sind:
- Keine schweren unerwünschten Ereignisse (SAEs) oder behandlungsbedingten unerwünschten Ereignisse (TEAEs), die mit Laborwerten oder EKGs in Zusammenhang stehen
- Die Mehrheit der TEAEs war mild, mit nur einem Rückzug bei der höchsten MAD-Dosis
- Zwei MAD-Kohorten, die innerhalb des erwarteten therapeutischen Bereichs abgeschlossen wurden, zeigten eine ausgezeichnete Verträglichkeit
Die Studie zielt darauf ab, die Sicherheit, Verträglichkeit und Pharmakokinetik sowohl bei gesunden Freiwilligen als auch bei UC-Patienten zu bewerten. Die Studie wird verschiedene Biomarker analysieren, darunter hsCRP, fäkale Calprotectin und histologische Bewertungen von Dickdarmgewebe. Die wichtigsten Daten werden in der ersten Hälfte des Jahres 2025 erwartet.
- Strong preliminary safety profile with no serious adverse events
- Excellent tolerability in therapeutic dose range cohorts
- Successfully transitioned to UC patient dosing
- Study progressing on schedule for H1 2025 data readout
- One patient withdrawal at highest MAD dose level
Insights
Palisade Bio's transition to dosing ulcerative colitis (UC) patients in their Phase 1a/b study of PALI-2108 marks a pivotal advancement in their clinical program. The preliminary safety profile appears promising, with no serious adverse events and no treatment-emergent adverse events related to laboratory values or EKGs across multiple cohorts. This is particularly significant for a PDE4 inhibitor, as this drug class has historically faced tolerability challenges.
The data from cohorts within the expected therapeutic range is especially encouraging, with one cohort reporting no adverse events at all. This suggests PALI-2108 may potentially offer an improved safety profile compared to existing PDE4 inhibitors like Otezla (apremilast) and Daliresp (roflumilast), though direct comparisons would be premature at this stage.
The ulcerative colitis market represents a substantial opportunity, with approximately 1 million Americans affected and a global market expected to reach
The single withdrawal at the highest MAD dose level is not unusual in dose-escalation studies and helps establish the upper dosing limits. More importantly, the company has identified dose levels with excellent tolerability that appear to be within the therapeutic range.
For investors in this
The collection of biomarker data, including tissue PDE4 expression and cAMP levels, will provide important insights into target engagement and potential efficacy signals - information that could significantly enhance the value proposition of PALI-2108 beyond just safety data.
Positive preliminary data from all five single ascending dose (SAD) cohorts and first three completed multiple ascending dose (MAD) cohorts support safety and tolerability of PALI-2108
No serious adverse events (SAEs) and no treatment-emergent adverse events (TEAEs) related to laboratory values or EKGs seen to date
On track to report topline data in first half of 2025
Carlsbad, CA, March 14, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio”, or the “Company”), a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today provided an update on its ongoing Phase 1a/b study of PALI-2108 for the treatment of Ulcerative Colitis (UC).
The Company has commenced dosing of the first UC patient in the final cohort of its Phase 1a/b study of PALI-2108. In addition to completing the five previous Phase 1a SAD cohorts, the first three of four MAD cohorts have now been completed. Importantly, there have been no SAEs and no TEAEs related to laboratory values or EKGs. The majority of observed TEAEs were considered mild, with a single withdrawal at the highest MAD dose level. Two of the MAD cohorts were completed within the expected therapeutic dose range, again showing no SAEs or TEAEs related to laboratory values or EKGs. One of these cohorts was completed with no TEAEs, underscoring the excellent tolerability of PALI-2108 at these dose levels.
“We are pleased with the initiation of the final MAD and UC cohorts in our Phase 1a/b study of PALI-2108. Of particular note is our successful transition from healthy volunteers to dosing our first cohort of patients with UC. The preliminary results from our SAD and MAD cohorts align with management’s expectations. We look forward to further evaluations, and we remain on track to report topline data in the first half of 2025,” 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
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