Spyre Therapeutics Announces Poster Presentation at the 20th Congress of the European Crohn's and Colitis Organisation
Spyre Therapeutics (NASDAQ: SYRE) presented preclinical findings at the 20th Congress of the European Crohn's and Colitis Organisation (ECCO) demonstrating superior results from combined inhibition of α4β7 integrin and TL1A cytokine compared to individual treatments in mouse colitis models.
The research showed that the company's SPY120 program achieved additive or greater than additive efficacy through combined target inhibition. Pharmacokinetic studies in non-human primates revealed that SPY001 and SPY002 antibodies maintained similar profiles whether administered alone or in combination, suggesting potential for quarterly or twice-annual dosing in humans.
The company plans to initiate a Phase 2 trial in ulcerative colitis patients by mid-2025, testing three combinations: SPY120, SPY130, and SPY230.
Spyre Therapeutics (NASDAQ: SYRE) ha presentato risultati preclinici al 20° Congresso dell'Organizzazione Europea per il Morbo di Crohn e la Colite (ECCO), dimostrando risultati superiori dall'inibizione combinata dell'integrina α4β7 e del citocina TL1A rispetto ai trattamenti singoli in modelli di colite nei topi.
La ricerca ha mostrato che il programma SPY120 dell'azienda ha raggiunto un'efficacia additiva o maggiore attraverso l'inibizione combinata dei target. Studi farmacocinetici su primati non umani hanno rivelato che gli anticorpi SPY001 e SPY002 hanno mantenuto profili simili sia se somministrati da soli che in combinazione, suggerendo un potenziale per dosaggi trimestrali o semestrali negli esseri umani.
L'azienda prevede di avviare un trial di Fase 2 in pazienti con colite ulcerosa entro la metà del 2025, testando tre combinazioni: SPY120, SPY130 e SPY230.
Spyre Therapeutics (NASDAQ: SYRE) presentó hallazgos preclínicos en el 20º Congreso de la Organización Europea de Enfermedad de Crohn y Colitis (ECCO), demostrando resultados superiores de la inhibición combinada del integrina α4β7 y la citoquina TL1A en comparación con tratamientos individuales en modelos de colitis en ratones.
La investigación mostró que el programa SPY120 de la empresa logró una eficacia aditiva o mayor que la aditiva a través de la inhibición combinada de los objetivos. Los estudios farmacocinéticos en primates no humanos revelaron que los anticuerpos SPY001 y SPY002 mantuvieron perfiles similares, ya sea administrados solos o en combinación, sugiriendo un potencial para dosificaciones trimestrales o semestrales en humanos.
La empresa planea iniciar un ensayo de Fase 2 en pacientes con colitis ulcerosa para mediados de 2025, probando tres combinaciones: SPY120, SPY130 y SPY230.
Spyre Therapeutics (NASDAQ: SYRE)는 제20회 유럽 크론병 및 궤양성 대장염 기구(ECCO)에서 전임상 결과를 발표하며, 마우스 대장염 모델에서 α4β7 인테그린과 TL1A 사이토카인의 복합 억제가 개별 치료보다 우수한 결과를 나타냈습니다.
연구에 따르면, 회사의 SPY120 프로그램은 복합 표적 억제를 통해 추가적이거나 그 이상의 효능을 달성했습니다. 비인간 영장류에서의 약리학적 연구 결과, SPY001 및 SPY002 항체는 단독 또는 조합으로 투여될 때 유사한 프로필을 유지하여, 인간에게 분기별 또는 연 2회의 투여 가능성을 제시했습니다.
회사는 2025년 중반까지 궤양성 대장염 환자를 대상으로 2상 시험을 시작할 계획이며, 세 가지 조합: SPY120, SPY130 및 SPY230을 테스트할 예정입니다.
Spyre Therapeutics (NASDAQ: SYRE) a présenté des résultats précliniques lors du 20e Congrès de l'Organisation Européenne de la Maladie de Crohn et de la Colite (ECCO), démontrant des résultats supérieurs grâce à l'inhibition combinée de l'intégrine α4β7 et de la cytokine TL1A par rapport aux traitements individuels dans des modèles de colite chez la souris.
La recherche a montré que le programme SPY120 de l'entreprise a atteint une efficacité additive ou supérieure grâce à l'inhibition combinée des cibles. Des études pharmacocinétiques chez des primates non humains ont révélé que les anticorps SPY001 et SPY002 maintenaient des profils similaires, qu'ils soient administrés seuls ou en combinaison, suggérant un potentiel pour des dosages trimestriels ou semestriels chez les humains.
L'entreprise prévoit de lancer un essai de Phase 2 chez des patients atteints de colite ulcéreuse d'ici mi-2025, testant trois combinaisons : SPY120, SPY130 et SPY230.
Spyre Therapeutics (NASDAQ: SYRE) präsentierte präklinische Ergebnisse auf dem 20. Kongress der Europäischen Crohn- und Colitis-Organisation (ECCO), die überlegene Ergebnisse bei der kombinierten Hemmung von α4β7-Integrin und TL1A-Zytokin im Vergleich zu einzelnen Behandlungen in Mausmodellen für Kolitis zeigten.
Die Forschung zeigte, dass das SPY120-Programm des Unternehmens durch kombinierte Zielhemmung additive oder höhere Wirksamkeit erreichte. Pharmakokinetische Studien an nichtmenschlichen Primaten ergaben, dass die Antikörper SPY001 und SPY002 ähnliche Profile beibehielten, unabhängig davon, ob sie alleine oder in Kombination verabreicht wurden, was auf ein Potenzial für vierteljährliche oder halbjährliche Dosierungen beim Menschen hindeutet.
Das Unternehmen plant, bis Mitte 2025 eine Phase-2-Studie bei Patienten mit ulzerierender Kolitis zu starten, in der drei Kombinationen getestet werden: SPY120, SPY130 und SPY230.
- Preclinical data shows superior efficacy of combined therapy versus monotherapy
- Pharmacokinetic profiles support potential for quarterly or twice-annual dosing
- Phase 2 trial in ulcerative colitis planned for mid-2025
- Still in early preclinical stage with no human trial data
- Efficacy demonstrated only in mouse models
Insights
The preclinical data presented at ECCO represents a significant milestone in Spyre's development of combination therapies for IBD. The superior efficacy demonstrated by dual inhibition of α4β7 integrin and TL1A cytokine, compared to monotherapies, suggests a potentially transformative approach to IBD treatment. This is particularly noteworthy as current IBD therapies often face challenges with long-term efficacy and patient compliance.
The pharmacokinetic profile supporting quarterly or twice-annual dosing could represent a major competitive advantage in the $20+ billion IBD market. Current biologics typically require monthly or bi-monthly administration, making Spyre's extended dosing interval particularly attractive for both patients and healthcare providers. This could significantly improve treatment adherence and potentially lead to better clinical outcomes.
The company's strategic approach of developing three distinct combination therapies (SPY120, SPY130, and SPY230) demonstrates a sophisticated pipeline strategy. By targeting multiple inflammatory pathways simultaneously, these combinations could potentially address the heterogeneous nature of IBD and provide more comprehensive disease control. The planned Phase 2 trial initiation in mid-2025 will be a important inflection point for validating this approach in human patients.
However, it's important to note that while preclinical results are promising, the translation to human efficacy remains to be proven. The IBD therapeutic landscape is highly competitive, with several established players and novel approaches in development. Success in Phase 2 trials will be critical for establishing Spyre's position in this market.
"We are thrilled to share these recent preclinical findings supporting the combination potential for our SPY120 program (anti-α4β7 and anti-TL1A). We tested mouse surrogates of SPY120 in two in vivo models of IBD, demonstrating that combined inhibition of the α4β7 integrin and TL1A cytokine provide additive or greater than additive efficacy relative to inhibition of either target alone," said Andy Spencer, PhD, SVP of Preclinical R&D at Spyre. "Further, the pharmacokinetic profiles of our SPY001 and SPY002 antibodies in NHPs were similar when dosed as monotherapies or in combination, indicating the potential for quarterly or twice-annual dosing of SPY120 in humans. Together, these results demonstrate the potential for SPY120 to have best-in-indication efficacy and convenience in IBD, complementing our previously disclosed preclinical results for SPY130 (anti-α4β7 and anti-IL-23) and SPY230 (anti-TL1A and anti-IL-23). We look forward to testing all three potential best-in-indication combinations in our Phase 2 trial in ulcerative colitis patients which is expected to begin mid-year."
The poster will be available for viewing during the ECCO Congress beginning on February 19, 2025, and details are as follows:
Title: Combined inhibition of TL1A and integrin β7 is superior to either monotherapy in mouse models of colitis and coadministration of SPY001 and SPY002 demonstrates no drug-drug effects on exposure in non-human primates
Authors: M Siegel, J Friedman, D Nguyen, J McNally, M Kennedy, O Ballew, M Rose, A Spencer
Full session details can be accessed via the ECCO program.
About Spyre Therapeutics
Spyre Therapeutics is a biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. Spyre's pipeline includes extended half-life antibodies targeting α4β7, TL1A, and IL-23. For more information, visit Spyre's website at www.spyre.com.
Forward-Looking Statements
Certain statements in this press release, other than purely historical information, may constitute "forward-looking statements" within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995, concerning Spyre and other matters. These forward-looking statements include, but are not limited to, express or implied statements relating to Spyre's management team's expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, Spyre's ability to achieve the expected benefits or opportunities with respect to its pipeline of product candidates such as potential dosing regimens of SPY120 in humans; the potential for SPY120, SPY130 and SPY230 to be best-in-indication combinations, including the potential for SPY120 to have best-in-indication efficacy and convenience in IBD; Spyre's future clinical development activities, including its planned Phase 2 trial in ulcerative colitis and timing thereof; the potential therapeutic benefits of Spyre's product candidates as monotherapies and or in combination; and the timing and results of clinical trials. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "opportunity," "potential," "milestones," "pipeline," "can," "goal," "aim," "strategy," "target," "seek," "anticipate," "achieve," "believe," "contemplate," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "predict," "project," "should," "will," "would," "slated" and similar expressions (including the negatives of these terms or variations of them) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Spyre will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Spyre's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited those uncertainties and factors described under the heading "Risk Factors" and "Note about Forward-Looking Statements" in Spyre's most recent Quarterly Report on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors included in other filings by Spyre from time to time. Should one or more of these risks or uncertainties materialize, or should any of Spyre's assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Spyre does not undertake or accept any duty to make any updates or revisions to any forward-looking statements. This press release does not purport to summarize all of the conditions, risks and other attributes of an investment in Spyre.
View original content to download multimedia:https://www.prnewswire.com/news-releases/spyre-therapeutics-announces-poster-presentation-at-the-20th-congress-of-the-european-crohns-and-colitis-organisation-302379930.html
SOURCE Spyre Therapeutics, Inc.
FAQ
What were the key findings of Spyre Therapeutics' (SYRE) ECCO 2025 presentation?
When will Spyre Therapeutics (SYRE) begin Phase 2 trials for SPY120?
What is the potential dosing frequency for Spyre Therapeutics' (SYRE) SPY120?
What combinations will Spyre Therapeutics (SYRE) test in their Phase 2 ulcerative colitis trial?
