Spyre Therapeutics Announces Poster Presentations at Digestive Disease Week (DDW) 2025 Including Up to Eight months of Follow-up from an Ongoing Phase 1 Trial of SPY001
Spyre Therapeutics (NASDAQ: SYRE) presented promising data from its ongoing Phase 1 trial of SPY001, a novel half-life extended α4β7 antibody for Inflammatory Bowel Disease (IBD) treatment, at Digestive Disease Week 2025. The trial results showed SPY001 is well-tolerated with a half-life more than three times longer than vedolizumab. A single dose demonstrated rapid and sustained α4β7 receptor saturation at expected Phase 2 trough concentrations.
The company remains on schedule to launch its platform Phase 2 trial in mid-2025, testing SPY001 as both monotherapy and in combination with SPY002 (TL1A) and SPY003 (IL-23). Initial monotherapy data is expected in 2026. Preclinical data also showed that combined inhibition of α4β7 integrin and TL1A cytokine demonstrated superior results compared to monotherapy in mouse colitis models.
Spyre Therapeutics (NASDAQ: SYRE) ha presentato dati promettenti dal suo trial di Fase 1 in corso su SPY001, un nuovo anticorpo α4β7 a emivita prolungata per il trattamento delle Malattie Infiammatorie Intestinali (IBD), durante la Digestive Disease Week 2025. I risultati dello studio hanno evidenziato che SPY001 è ben tollerato e presenta un'emivita superiore di oltre tre volte rispetto a vedolizumab. Una singola dose ha mostrato una saturazione rapida e duratura del recettore α4β7 a concentrazioni di fase 2 previste.
L'azienda resta in linea con i tempi previsti per l'avvio del trial di Fase 2 della piattaforma a metà 2025, testando SPY001 sia come monoterapia sia in combinazione con SPY002 (TL1A) e SPY003 (IL-23). I primi dati sulla monoterapia sono attesi nel 2026. I dati preclinici hanno inoltre dimostrato che l'inibizione combinata dell'integrina α4β7 e della citochina TL1A ha mostrato risultati superiori rispetto alla monoterapia nei modelli murini di colite.
Spyre Therapeutics (NASDAQ: SYRE) presentó datos prometedores de su ensayo de Fase 1 en curso con SPY001, un nuevo anticuerpo α4β7 de vida media prolongada para el tratamiento de la Enfermedad Inflamatoria Intestinal (EII), en la Digestive Disease Week 2025. Los resultados del ensayo mostraron que SPY001 es bien tolerado y tiene una vida media más de tres veces mayor que vedolizumab. Una sola dosis demostró una rápida y sostenida saturación del receptor α4β7 a concentraciones esperadas para la Fase 2.
La compañía mantiene el cronograma para lanzar su ensayo de Fase 2 de plataforma a mediados de 2025, probando SPY001 tanto en monoterapia como en combinación con SPY002 (TL1A) y SPY003 (IL-23). Se esperan los primeros datos de monoterapia en 2026. Los datos preclínicos también mostraron que la inhibición combinada de la integrina α4β7 y la citocina TL1A mostró resultados superiores en comparación con la monoterapia en modelos murinos de colitis.
Spyre Therapeutics (NASDAQ: SYRE)는 진행 중인 1상 시험에서 SPY001이라는 새로운 반감기 연장형 α4β7 항체를 염증성 장질환(IBD) 치료제로서 Digestive Disease Week 2025에서 유망한 데이터를 발표했습니다. 시험 결과 SPY001은 내약성이 우수하며, 베돌리주맙보다 반감기가 3배 이상 길다는 것을 보여주었습니다. 단일 투여로도 2상 예상 최저 농도에서 α4β7 수용체의 빠르고 지속적인 포화가 확인되었습니다.
회사는 2025년 중반에 플랫폼 2상 시험을 시작할 계획이며, SPY001을 단독요법과 SPY002(TL1A), SPY003(IL-23)과의 병용요법으로 시험할 예정입니다. 단독요법 초기 데이터는 2026년에 발표될 예정입니다. 전임상 데이터는 α4β7 인테그린과 TL1A 사이토카인의 병합 억제가 쥐 대장염 모델에서 단독요법보다 우수한 결과를 나타냈음을 보여주었습니다.
Spyre Therapeutics (NASDAQ : SYRE) a présenté des données prometteuses issues de son essai de phase 1 en cours sur SPY001, un nouvel anticorps α4β7 à demi-vie prolongée destiné au traitement des maladies inflammatoires de l'intestin (MII), lors de la Digestive Disease Week 2025. Les résultats de l'essai ont montré que SPY001 est bien toléré et possède une demi-vie plus de trois fois supérieure à celle du vedolizumab. Une dose unique a démontré une saturation rapide et durable du récepteur α4β7 aux concentrations attendues pour la phase 2.
L'entreprise reste dans les délais pour lancer son essai de phase 2 plateforme à la mi-2025, testant SPY001 à la fois en monothérapie et en association avec SPY002 (TL1A) et SPY003 (IL-23). Les premières données en monothérapie sont attendues en 2026. Les données précliniques ont également montré que l'inhibition combinée de l'intégrine α4β7 et de la cytokine TL1A offrait de meilleurs résultats que la monothérapie dans des modèles murins de colite.
Spyre Therapeutics (NASDAQ: SYRE) präsentierte vielversprechende Daten aus der laufenden Phase-1-Studie zu SPY001, einem neuartigen, verlängerter Halbwertszeit α4β7-Antikörper zur Behandlung von entzündlichen Darmerkrankungen (IBD), auf der Digestive Disease Week 2025. Die Studienergebnisse zeigten, dass SPY001 gut verträglich ist und eine mehr als dreimal längere Halbwertszeit als Vedolizumab aufweist. Eine Einzeldosis zeigte eine schnelle und anhaltende Sättigung des α4β7-Rezeptors bei den erwarteten Phase-2-Talspiegeln.
Das Unternehmen bleibt im Zeitplan, um Mitte 2025 die Plattform-Phase-2-Studie zu starten, in der SPY001 sowohl als Monotherapie als auch in Kombination mit SPY002 (TL1A) und SPY003 (IL-23) getestet wird. Erste Monotherapiendaten werden für 2026 erwartet. Präklinische Daten zeigten zudem, dass die kombinierte Hemmung von α4β7-Integrin und dem Zytokin TL1A in Maus-Colitis-Modellen bessere Ergebnisse erzielte als die Monotherapie.
- SPY001 demonstrated a half-life more than 3x longer than vedolizumab
- Phase 1 trial showed SPY001 is well-tolerated
- Preclinical data showed superior results for combined α4β7 and TL1A inhibition vs monotherapy
- Company on track for Phase 2 trial initiation in mid-2025
- None.
Insights
Spyre's SPY001 shows 3x longer half-life than vedolizumab, supporting potential quarterly/biannual IBD dosing with confirmed Phase 2 timeline.
The extended eight-month follow-up data from Spyre's Phase 1 trial of SPY001 demonstrates significant pharmacokinetic advantages for this novel α4β7 antibody in IBD treatment. The data confirms SPY001 has a half-life more than three times longer than vedolizumab (Entyvio), a currently approved α4β7 therapy. This extended half-life could enable quarterly or biannual maintenance dosing, representing a substantial improvement over current therapies requiring more frequent administration.
Pharmacodynamic data shows a single SPY001 dose achieves rapid and sustained saturation of α4β7 receptors at expected Phase 2 trough concentrations. This is crucial for efficacy, as effective α4β7 inhibition prevents inflammatory cell migration to intestinal tissue. The press release specifically notes SPY001 is "well tolerated," though detailed safety data isn't provided.
The preclinical findings supporting combined inhibition of α4β7 integrin and TL1A cytokine provide scientific rationale for Spyre's combination therapy approach. While these mouse model results require clinical validation, they align with the company's strategic platform trial design.
Spyre confirmed its timeline to initiate a Phase 2 platform trial in ulcerative colitis patients by mid-2025, with initial monotherapy data expected in 2026. This platform approach efficiently evaluates multiple assets (SPY001, SPY002, SPY003) and combinations within one trial framework.
These updates strengthen SPY001's potential best-in-class profile in the competitive IBD landscape. While promising, these Phase 1 results will need confirmation in larger trials measuring clinical endpoints like symptom improvement and endoscopic healing to fully validate SPY001's competitive advantages.
SPY001 is a novel, half-life extended α4β7 antibody in development for the treatment of Inflammatory Bowel Disease (IBD)
SPY001 pharmacokinetic (PK) data up to eight months continues to support a potential best-in-class profile, including a half-life more than three times that of vedolizumab
SPY001 pharmacodynamic (PD) data up to eight months showed that a single dose of SPY001 resulted in rapid and sustained saturation of α4β7 receptors at expected Phase 2 trough concentrations
Spyre remains on track to initiate its planned platform Phase 2 trial in mid-2025 that includes SPY001, followed by SPY002 (TL1A), SPY003 (IL-23), and combinations thereof, with initial monotherapy data expected in 2026
- Spyre presented results out to eight months of follow up from its SPY001 Phase 1 program. Updated results from our ongoing Phase 1 trial of SPY001, our novel half-life extended α4β7 antibody for the treatment of IBD, continues to show that SPY001 is well tolerated, has a half-life of more than three-fold compared to vedolizumab based on population PK modeling, and sustains target engagement at expected Phase 2 trough concentrations. This longer follow-up data strengthens the potential for SPY001 to demonstrate improved induction responses with greater exposures as well as durable responses with quarterly or biannual maintenance dosing.
- Spyre presented expanded preclinical data on combined inhibition of α4β7 integrin and TL1A cytokine in murine colitis models. Data presented demonstrate that combined inhibition of α4β7 integrin and TL1A cytokine is superior to either monotherapy in mouse models of colitis.
"Extended follow-up data continue to show that SPY001 is well tolerated and has a PK and PD profile that supports potential best-in-class quarterly or biannual dosing for patients with IBD," said Deanna Nguyen, MD, SVP of Clinical Development at Spyre. "We look forward to testing SPY001 as a monotherapy and as a backbone for combinations in our Phase 2 platform trial in ulcerative colitis patients, which remains on-track to begin mid-year."
The poster will be available for viewing during the DDW exhibition, and details are as follows:
Title: Interim PK Data for SPY001, a Novel Half-Life Extended Monoclonal Antibody Targeting α4β7, Suggest a Potential for Q3M or Q6M Maintenance Dosing for Inflammatory Bowel Disease
Authors: D Nguyen, L Yan, K Hew, P Patel, R McLean, R Himes, T Das, M Huyghe, B Connolly, J Friedman
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 DDW Program.
About SPY001
SPY001 is an investigational novel, extended half-life monoclonal antibody targeting α4β7 for the treatment of IBD. IBD is a chronic condition characterized by inflammation in the gastrointestinal tract and encompasses two main disorders: ulcerative colitis and Crohn's disease. In
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 best-in-class dosing regimen and safety profile of SPY001 in humans; expectations regarding the drug delivery of SPY001, including in the form of a single autoinjector; Spyre's future clinical development activities, including the expected design and timing of the planned platform Phase 2 trial of SPY001, SPY002, SPY003 and combinations thereof and timing of each cohort and data readouts; the potential therapeutic benefits of Spyre's product candidates as monotherapies or in combinations and their extended half-life, including the expected duration of half-life in comparison to competitor products and the potential efficacy, durability and exposure of induction responses for SPY001; 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," 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 Annual Report on From 10-K 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.
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SOURCE Spyre Therapeutics, Inc.
FAQ
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