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Spyre Therapeutics Announces Expected Acceleration of SPY003 (IL-23p19) Clinical Timelines and Presentations at UEGW supporting Spyre's Portfolio of Potentially Best-in-Class Antibodies and Combinations

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Spyre Therapeutics (NASDAQ: SYRE) announced accelerated timelines for SPY003, its novel half-life extended IL-23p19 monoclonal antibody, with first-in-human dosing now expected in Q1 2025. New data presented at UEGW showed SPY003's robust preclinical activity, including comparable potency and >3-fold half-life extension in NHPs relative to risankizumab. Spyre's portfolio now includes extended half-life molecules targeting α4β7, TL1A, and IL-23 with potential Q8W-Q12W maintenance dosing.

Additional preclinical data on SPY003 in combination with SPY001 or SPY002 demonstrated enhanced efficacy and pharmacodynamics. The company expects to share interim data from the accelerated first-in-human trial in H2 2025. Spyre also presented preclinical data on SPY001 (anti-α4β7) and SPY002 (anti-TL1A) at UEGW, supporting potential Q8-12W dosing regimens in IBD.

Spyre Therapeutics (NASDAQ: SYRE) ha annunciato tempistiche accelerate per SPY003, il suo innovativo anticorpo monoclonale con vita media estesa IL-23p19, con la prima somministrazione nell'uomo ora prevista per il primo trimestre del 2025. Nuovi dati presentati all'UEGW hanno mostrato la robusta attività preclinica di SPY003, inclusa una potenza comparabile e un'estensione della vita media superiore a tre volte rispetto al risankizumab negli animali non umani. Il portafoglio di Spyre ora include molecole a vita media estesa che mirano a α4β7, TL1A e IL-23, con potenziali dosaggi di mantenimento Q8W-Q12W.

Dati preclinici supplementari su SPY003 in combinazione con SPY001 o SPY002 hanno dimostrato un'efficacia e una farmacodinamica migliorate. L'azienda prevede di condividere dati provvisori dallo studio clinico di prima somministrazione accelerato nella seconda metà del 2025. Spyre ha anche presentato dati preclinici su SPY001 (anti-α4β7) e SPY002 (anti-TL1A) all'UEGW, a sostegno dei potenziali regimi di dosaggio Q8-12W in IBD.

Spyre Therapeutics (NASDAQ: SYRE) anunció cronogramas acelerados para SPY003, su novedoso anticuerpo monoclonal IL-23p19 con vida media extendida, con la primera dosificación en humanos ahora prevista para el primer trimestre de 2025. Los nuevos datos presentados en el UEGW mostraron la robusta actividad preclínica de SPY003, incluyendo potencia comparable y una extensión de vida media más de tres veces superior en primates no humanos en relación con el risankizumab. El portafolio de Spyre ahora incluye moléculas de vida media extendida que apuntan a α4β7, TL1A e IL-23, con posibles esquemas de dosis de mantenimiento Q8W-Q12W.

Datos preclínicos adicionales sobre SPY003 en combinación con SPY001 o SPY002 demostraron una eficacia y farmacodinámica mejoradas. La empresa espera compartir datos interinos del ensayo clínico acelerado de primera dosificación en la segunda mitad de 2025. Spyre también presentó datos preclínicos sobre SPY001 (anti-α4β7) y SPY002 (anti-TL1A) en UEGW, respaldando posibles regímenes de dosificación Q8-12W en IBD.

스파이레 치료제(미국 NASDAQ: SYRE)는 혁신적인 반감기 연장 IL-23p19 단일클론 항체 SPY003의 임상 진행 일정을 세분화하여 최초 인간 투여가 2025년 1분기로 예상된다고 발표했습니다. UEGW에서 발표된 새로운 데이터는 SPY003의 견고한 전임상 활성을 보여주었으며, risankizumab과 비교해 NHP(비인간 원숭이)에서 3배 이상의 반감기 연장을 포함하여 유사한 효능을 강조했습니다. 스파이레의 포트폴리오는 이제 α4β7, TL1A 및 IL-23을 타겟으로 하는 반감기 연장 분자를 포함하며, Q8W-Q12W 유지 용량의 잠재성을 지니고 있습니다.

SPY001 또는 SPY002와 함께한 SPY003에 대한 추가 전임상 데이터는 향상된 효능과 약리역학을 입증했습니다. 이 회사는 2025년 하반기까지 가속화된 최초 인간 시험에서 중간 데이터를 공유할 것으로 기대하고 있습니다. 스파이레는 또한 UEGW에서 IBD에서의 잠재적인 Q8-12W 용량 요법을 지지하는 SPY001(항-α4β7) 및 SPY002(항-TL1A)에 대한 전임상 데이터를 발표했습니다.

Spyre Therapeutics (NASDAQ: SYRE) a annoncé des délais accélérés pour SPY003, son nouvel anticorps monoclonal IL-23p19 à demi-vie prolongée, avec une première dose chez l'homme maintenant prévue pour le premier trimestre 2025. Nouveaux données présentées à l'UEGW ont montré l'activité préclinique robuste de SPY003, y compris une puissance comparable et une extension de plus de trois fois de la demi-vie chez les NHP par rapport au risankizumab. Le portefeuille de Spyre comprend désormais des molécules à demi-vie prolongée ciblant α4β7, TL1A et IL-23, avec des dosages de maintenance potentiels de Q8W-Q12W.

Des données précliniques supplémentaires sur SPY003 en combinaison avec SPY001 ou SPY002 ont démontré une efficacité et une pharmacodynamique améliorées. L'entreprise prévoit de partager des données intermédiaires de l'essai clinique accéléré de première dose chez l'homme au second semestre 2025. Spyre a également présenté des données précliniques sur SPY001 (anti-α4β7) et SPY002 (anti-TL1A) à l'UEGW, soutenant des schémas de dosage potentiels de Q8-12W en IBD.

Spyre Therapeutics (NASDAQ: SYRE) hat beschleunigte Zeitpläne für SPY003, seinen neuartigen, mit verlängerter Halbwertszeit ausgestatteten IL-23p19-Monoklonalen Antikörper, bekannt gegeben, wobei die erste Dosierung bei Menschen nun für das erste Quartal 2025 erwartet wird. Neue Daten, die auf der UEGW vorgestellt wurden zeigten die robuste präklinische Aktivität von SPY003, einschließlich einer vergleichbaren Potenz und einer über dreifachen Verlängerung der Halbwertszeit bei NHPs im Vergleich zu Risankizumab. Das Portfolio von Spyre umfasst nun verlängerte Halbwertszeitmoleküle, die auf α4β7, TL1A und IL-23 abzielen, mit potenziellen Q8W-Q12W Erhaltungsdosierungen.

Zusätzliche präklinische Daten zu SPY003 in Kombination mit SPY001 oder SPY002 zeigten eine verbesserte Wirksamkeit und Pharmakodynamik. Das Unternehmen erwartet, in der zweiten Hälfte von 2025 vorläufige Daten aus der beschleunigten ersten Anwendung beim Menschen zu teilen. Spyre präsentierte auch präklinische Daten zu SPY001 (anti-α4β7) und SPY002 (anti-TL1A) auf der UEGW, die potenzielle Q8-12W Dosierungsschemata bei IBD unterstützen.

Positive
  • Accelerated timeline for SPY003 first-in-human dosing to Q1 2025
  • SPY003 showed >3-fold half-life extension compared to risankizumab in preclinical studies
  • Potential for quarterly or twice-yearly dosing of SPY003 as monotherapy in maintenance
  • Preclinical data supports potential Q8-12W dosing regimens for SPY001 and SPY002 in IBD
  • Enhanced efficacy and pharmacodynamics demonstrated in preclinical studies of SPY003 combinations
Negative
  • None.

Insights

Spyre Therapeutics is making significant strides in developing potentially best-in-class antibodies for inflammatory bowel disease (IBD) treatment. The acceleration of SPY003 (IL-23p19) clinical timelines is particularly noteworthy, with first-in-human dosing now expected in Q1 2025. This puts Spyre on a faster track to potentially disrupt the IBD treatment landscape.

Key highlights:

  • SPY003 shows comparable potency to risankizumab with a 300% longer half-life in non-human primates, potentially enabling quarterly or bi-annual dosing.
  • Spyre's portfolio now includes extended half-life molecules targeting α4β7, TL1A and IL-23, positioning them uniquely in the market for combination therapies.
  • Preclinical data on SPY003 in combination with SPY001 or SPY002 demonstrated enhanced efficacy, suggesting potential for superior treatment options.
  • The company expects to share interim data from the SPY003 first-in-human trial in H2 2025, which could be a significant catalyst for investor interest.

While still in early stages, Spyre's approach of combining best-in-class antibody engineering with rational therapeutic combinations could lead to improved efficacy and convenience in IBD treatment. This potential for differentiation in a competitive market makes Spyre an interesting player to watch in the biotech space.

The preclinical data presented by Spyre Therapeutics at UEGW is promising and supports their strategy of developing extended half-life antibodies for IBD treatment. The combination therapy approach, particularly the synergistic effects observed with anti-IL-23 and anti-TL1A, is scientifically intriguing and aligns with the current trend towards more targeted, personalized treatments in gastroenterology.

Key scientific insights:

  • SPY003's 30-day half-life in non-human primates could translate to significantly improved patient compliance and quality of life if replicated in humans.
  • The synergistic suppression of IL-17 secretion by anti-IL-23 and anti-TL1A combination suggests a potential for enhanced efficacy in controlling inflammation.
  • In vivo models showing improved body weight and reduced colonic CD4+ infiltration with combination therapy provide a strong rationale for further clinical investigation.

While these results are encouraging, it's important to remember that preclinical success doesn't always translate to clinical efficacy. The upcoming first-in-human trials, particularly for SPY003 and the SPY002 candidates, will be critical in validating these findings and determining the true potential of Spyre's approach in IBD treatment.

SPY003, a novel half-life extended IL-23p19 monoclonal antibody (mAb), with first-in-human dosing now expected first quarter 2025

New data on SPY003 presented at UEGW demonstrating robust preclinical activity including comparable potency and a greater than three-fold extension in half-life in NHPs relative to risankizumab1. Spyre portfolio now uniquely includes extended half-life molecules targeting α4β7, TL1A, and IL-23 with potential Q8W-Q12W maintenance dosing.

Additional preclinical data on SPY003 in combination with SPY001 or SPY002 presented at UEGW showing enhanced preclinical efficacy and pharmacodynamics

WALTHAM, Mass., Oct. 14, 2024 /PRNewswire/ -- Spyre Therapeutics, Inc. (NASDAQ: SYRE) (the "Company" or "Spyre"), a clinical-stage biotechnology company utilizing best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches to target improved efficacy and convenience in the treatment of inflammatory bowel disease ("IBD"), today announced updated pipeline progress and timelines, as well as scientific presentations at the United European Gastroenterology Week ("UEGW") Congress.

  • First-in-human dosing of SPY003 (anti-IL-23) in healthy volunteers is now expected to start during the first quarter of 2025. SPY003 is a novel, half-life extended mAb targeting IL-23p19 ("IL-23"). Approved inhibitors of IL-23 are effective and well tolerated treatments of moderate-to-severe IBD, with commercially available therapies dosed six times per year. SPY003 has the potential to be dosed quarterly or twice a year as a monotherapy in maintenance. The company expects to share interim data from the accelerated first-in-human trial in the second half of 2025.

  • Spyre presented preclinical data on SPY003 for the first time at UEGW, expanding its portfolio of half-life extended antibodies to three validated targets in IBD. The presentation illustrated in vitro potency comparable to risankizumab1 and pharmacokinetics indicating that SPY003 has a half-life of ~30 days in non-human primates ("NHPs"), a greater than three-fold increase relative to risankizumab1. These data demonstrate that SPY003 exhibits high selectivity and affinity for IL-23 and potently inhibits downstream cellular signaling. With an extended half-life in NHPs, SPY003 demonstrates therapeutic potential for effective and well-tolerated treatment of Crohn's disease ("CD") and Ulcerative Colitis ("UC") with less frequent dosing than approved therapies. In conjunction with its previously disclosed SPY001 (anti-α4β7) and SPY002 (anti-TL1A) programs, the company has a unique portfolio of antibodies that have the potential to be delivered in combination on a unified, Q8W-Q12W dosing frequency in maintenance.

  • Spyre presented preclinical data combining anti-IL-23 with either anti-α4β7 or anti-TL1A for the first time at UEGW. The presentation included in vitro studies and in vivo murine colitis model on anti-IL-23 combined with anti-TL1A and anti-α4β7, respectively. The models showed that IL-23 and TL1A have a synergistic effect on promoting IL-17 secretion from human and mouse immune cells, and that the combination of anti-IL-23 and anti-TL1A suppresses IL-17 secretion more effectively than either agent alone. In a T-cell transfer model of IBD, combination therapy with anti-IL-23 and anti-β7 improved body weight and reduced colonic CD4+ infiltration and IL-17 levels relative to monotherapy.

  • Additional preclinical data for SPY001 (anti-α4β7) and SPY002 (anti-TL1A) presented at UEGW. These presentations included in vitro potency compared to benchmark antibodies, nonclinical safety data, and pharmacokinetics demonstrating extended half-life in NHPs. For SPY002, characterization of the two development candidates planned for first-in-human studies in Q4 2024 is further described. Human pharmacokinetic simulations for SPY001 and both SPY002 candidates support potential Q8-12W dosing regimens in IBD.

"The Spyre team has made significant progress in advancing its potentially best-in-class molecules into first-in-human studies within an expected nine-month window," said Cameron Turtle, DPhil, chief executive officer of Spyre. "With these promising molecules against the top three validated targets in IBD, we believe that Spyre is uniquely positioned to develop monotherapy and combination products with the potential to meaningfully improve both efficacy and convenience compared to today's standard of care."

The posters were presented at the UEGW Congress on Saturday, October 12, 2024, and details are as follows:

Title: A Novel Monoclonal Antibody Drug Candidate SPY001 Targeting Integrin ɑ4β7 for the Treatment of IBD: In Vitro Properties and Non-Human Primate Pharmacokinetics and Safety
Poster #PP1103

Title: Characterization of Two Novel Extended Half-life Monoclonal Antibody Drug Candidates Targeting TL1A for the Treatment of IBD
Poster #MP450

Title: Development and Characterization of SPY003, a Novel Extended Half-life Monoclonal Antibody Drug Candidate Targeting IL-23 for the Treatment of IBD
Poster #MP118

Title: Combining IL-23 Blockade with Anti-ɑ4β7 or Anti-TL1A for the Treatment of IBD is Supported by In Vitro and Mouse IBD Model Experiments
Poster #PP1111

Full session details can be accessed via the UEGW program. New data disclosures are also available in Spyre's updated corporate presentation.

1Synthesized comparator antibody

About Spyre Therapeutics

Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation of inflammatory bowel disease (IBD) products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.

For more information, please visit http://spyre.com

Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical fact are forward-looking statements. These forward-looking statements include statements regarding the Company's business strategy, including the Company's potential success of developing best-in-class therapeutics for IBD with the potential to meaningfully improve both efficacy and convenience compared to today's standard of care,  the potential efficacy, safety and dosing profile of its product candidates, the potential therapeutic benefits of its product candidates as monotherapies or in combinations and their potential extended half-life, and the timing of clinical trials and interim data release, including first-in-human studies for SPY002 and SPY003.  The words "believe," "may," "will," "potentially," "estimate," "continue," "anticipate," "predict," "target," "intend," "could," "would," "should," "project," "plan," "expect," the negatives of these terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. 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.

Spyre Therapeutics, Inc. (PRNewsfoto/Spyre Therapeutics, Inc.)

 

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SOURCE Spyre Therapeutics, Inc.

FAQ

When is Spyre Therapeutics (SYRE) expecting to start first-in-human dosing of SPY003?

Spyre Therapeutics expects to start first-in-human dosing of SPY003 in healthy volunteers during the first quarter of 2025.

What potential dosing frequency does Spyre Therapeutics (SYRE) anticipate for SPY003 in maintenance therapy?

Spyre Therapeutics anticipates that SPY003 has the potential to be dosed quarterly or twice a year as a monotherapy in maintenance therapy.

What preclinical data did Spyre Therapeutics (SYRE) present at UEGW for SPY003?

At UEGW, Spyre presented preclinical data showing SPY003 has comparable potency to risankizumab and a greater than three-fold increase in half-life in non-human primates.

When does Spyre Therapeutics (SYRE) expect to share interim data from the SPY003 first-in-human trial?

Spyre Therapeutics expects to share interim data from the accelerated SPY003 first-in-human trial in the second half of 2025.

Spyre Therapeutics, Inc.

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