Spyre Therapeutics Announces First Participant Dosed in Phase 1 Trial of SPY003, its Novel Half-life Extended IL-23 Antibody
Spyre Therapeutics (NASDAQ: SYRE) has initiated dosing in a Phase 1 clinical trial of SPY003, its half-life extended anti-IL-23 monoclonal antibody, marking their fourth on-time clinical trial initiation in nine months. The trial (NCT06873724) is a double-blind, placebo-controlled single-ascending dose study expected to enroll approximately 56 healthy adult volunteers.
Preclinical data shows SPY003 is highly potent with potential for quarterly or biannual dosing, suggesting improved efficacy and convenience over first-generation anti-IL-23 antibodies. The study's primary endpoint is safety, with pharmacokinetics as a secondary endpoint.
Interim pharmacokinetic and safety data are anticipated in the second half of 2025. Following interim results, Spyre plans to incorporate SPY003 into its Phase 2 platform trial in ulcerative colitis, which will evaluate three investigational monotherapies and three investigational combination therapies.
Spyre Therapeutics (NASDAQ: SYRE) ha avviato la somministrazione in uno studio clinico di Fase 1 di SPY003, il suo anticorpo monoclonale anti-IL-23 con una vita media estesa, segnando il loro quarto avvio di studio clinico in tempo utile in nove mesi. Lo studio (NCT06873724) è un trial controllato, in doppio cieco, a dose singola e ascendente, che prevede di arruolare circa 56 volontari adulti sani.
I dati preclinici mostrano che SPY003 è altamente potente, con il potenziale per somministrazioni trimestrali o semestrali, suggerendo un miglioramento dell'efficacia e della comodità rispetto agli anticorpi anti-IL-23 di prima generazione. L'obiettivo principale dello studio è la sicurezza, con la farmacocinetica come obiettivo secondario.
I dati provvisori sulla farmacocinetica e sulla sicurezza sono attesi nella seconda metà del 2025. Dopo i risultati intermedi, Spyre prevede di includere SPY003 nel suo trial di piattaforma di Fase 2 per la colite ulcerosa, che valuterà tre monoterapie sperimentali e tre terapie combinate sperimentali.
Spyre Therapeutics (NASDAQ: SYRE) ha iniciado la dosificación en un ensayo clínico de Fase 1 de SPY003, su anticuerpo monoclonal anti-IL-23 con vida media extendida, marcando su cuarto inicio de ensayo clínico a tiempo en nueve meses. El ensayo (NCT06873724) es un estudio de dosis única ascendente, controlado con placebo y a doble ciego, que se espera que inscriba aproximadamente a 56 voluntarios adultos sanos.
Los datos preclínicos muestran que SPY003 es altamente potente, con potencial para dosis trimestrales o semestrales, lo que sugiere una mejor eficacia y conveniencia en comparación con los anticuerpos anti-IL-23 de primera generación. El objetivo principal del estudio es la seguridad, con la farmacocinética como objetivo secundario.
Se anticipan datos intermedios de farmacocinética y seguridad en la segunda mitad de 2025. Tras los resultados intermedios, Spyre planea incorporar SPY003 en su ensayo de plataforma de Fase 2 para la colitis ulcerosa, que evaluará tres monoterapias experimentales y tres terapias combinadas experimentales.
Spyre Therapeutics (NASDAQ: SYRE)는 반감기가 연장된 항-IL-23 단클론 항체인 SPY003의 1상 임상 시험에서 투약을 시작했으며, 이는 9개월 만에 네 번째 정시 임상 시험 시작을 의미합니다. 이 시험(NCT06873724)은 약 56명의 건강한 성인 자원자를 모집할 예정인 이중 맹검, 위약 대조 단일 상승 용량 연구입니다.
전임상 데이터에 따르면 SPY003는 매우 강력하며 분기별 또는 반기별 투약이 가능하다는 잠재력을 보여주고 있으며, 이는 1세대 항-IL-23 항체에 비해 효능과 편리성이 향상될 수 있음을 시사합니다. 연구의 주요 목표는 안전성이며, 약리학적 동태가 보조 목표입니다.
중간 약리학적 동태 및 안전성 데이터는 2025년 하반기에 예상됩니다. 중간 결과 이후, Spyre는 SPY003를 궤양성 대장염에 대한 2상 플랫폼 시험에 통합할 계획이며, 이 시험은 세 가지 실험적 단독 요법과 세 가지 실험적 병용 요법을 평가할 것입니다.
Spyre Therapeutics (NASDAQ: SYRE) a commencé la dose dans un essai clinique de Phase 1 de SPY003, son anticorps monoclonal anti-IL-23 à demi-vie prolongée, marquant leur quatrième initiation d'essai clinique à temps en neuf mois. L'essai (NCT06873724) est une étude à dose unique ascendante, contrôlée par placebo et en double aveugle, qui devrait recruter environ 56 adultes en bonne santé.
Les données précliniques montrent que SPY003 est très puissant avec un potentiel de dosage trimestriel ou semestriel, ce qui suggère une efficacité et une commodité améliorées par rapport aux anticorps anti-IL-23 de première génération. L'objectif principal de l'étude est la sécurité, avec la pharmacocinétique comme objectif secondaire.
Des données intermédiaires sur la pharmacocinétique et la sécurité sont attendues dans la seconde moitié de 2025. Après les résultats intermédiaires, Spyre prévoit d'incorporer SPY003 dans son essai de plateforme de Phase 2 pour la colite ulcéreuse, qui évaluera trois monothérapies expérimentales et trois thérapies combinées expérimentales.
Spyre Therapeutics (NASDAQ: SYRE) hat die Dosierung in einer Phase-1-Studie zu SPY003, seinem halbwertsverlängerten anti-IL-23-Monoklonalen Antikörper, begonnen und damit den vierten pünktlichen Start einer klinischen Studie innerhalb von neun Monaten markiert. Die Studie (NCT06873724) ist eine doppelblinde, placebo-kontrollierte Einzeldosis-Studie, die voraussichtlich etwa 56 gesunde Erwachsene rekrutieren wird.
Präklinische Daten zeigen, dass SPY003 sehr wirksam ist und das Potenzial für vierteljährliche oder halbjährliche Dosierungen bietet, was auf eine verbesserte Wirksamkeit und Bequemlichkeit im Vergleich zu Antikörpern der ersten Generation gegen IL-23 hinweist. Das primäre Ziel der Studie ist die Sicherheit, wobei die Pharmakokinetik als sekundäres Ziel dient.
Vorläufige Daten zur Pharmakokinetik und Sicherheit werden in der zweiten Hälfte des Jahres 2025 erwartet. Nach den vorläufigen Ergebnissen plant Spyre, SPY003 in seine Phase-2-Plattformstudie zur ulcerativen Kolitis einzubeziehen, die drei experimentelle Monotherapien und drei experimentelle Kombinationstherapien bewerten wird.
- Fourth consecutive on-time clinical trial initiation in nine months, demonstrating strong operational execution
- Preclinical data shows high potency with potential for less frequent dosing (quarterly/biannual)
- Planned integration into broader Phase 2 platform trial exploring multiple therapeutic combinations
- Initial efficacy data not expected until after second half of 2025
- Early-stage development (Phase 1) with significant clinical development risks ahead
Insights
Spyre's dosing initiation in a Phase 1 trial represents expected pipeline advancement with their fourth development candidate on schedule. SPY003, their half-life extended IL-23 antibody, enters the clinical arena targeting the established IL-23 pathway for inflammatory bowel disease treatment.
While the company highlights potential for quarterly or biannual dosing compared to current market options, we must recognize this as a Phase 1 safety study in healthy volunteers, not a therapeutic trial in patients. The trial will enroll approximately 56 participants with primary focus on safety and pharmacokinetics rather than efficacy.
The strategic significance lies in Spyre's combination therapy approach. Recent third-party data suggests IL-23 antibodies combined with other mechanisms produce superior IBD outcomes. Spyre clearly positions SPY003 as a component for their planned Phase 2 platform trial testing six investigational therapies including three combinations.
With interim data expected in H2 2025, the market impact remains near-term as efficacy signals in actual patients remain distant milestones. This represents standard pipeline progression rather than a transformative catalyst at this early stage.
Preclinical data demonstrates that SPY003 is highly potent and has potential for
quarterly or biannual dosing, suggesting opportunity for improved efficacy and
convenience over first-generation anti-IL-23 monoclonal antibodies
Interim pharmacokinetic and safety data from healthy volunteers for SPY003 anticipated
in the second half of 2025
Subject to interim results, Spyre expects to incorporate SPY003 into its planned Phase
2 study in ulcerative colitis exploring six investigational monotherapies and
combinations
"Recent third-party clinical data demonstrate that combination therapies that include an IL-23 antibody can produce superior results for IBD patients. We believe SPY003 has the potential to be a best-in-class IL-23 antibody and a compelling combination partner with our α4β7 and TL1A antibodies that can be delivered on a quarterly or bi-annual treatment schedule." said Deanna Nguyen, M.D., SVP of Clinical Development at Spyre. "We look forward to presenting the interim Phase 1 data in the second half of this year before adding SPY003 as the final monotherapy component of our planned Phase 2 platform trial in ulcerative colitis which will evaluate three investigational monotherapies and three investigational combination therapies."
The SPY003 Phase 1 Trial (NCT06873724) is a double-blind, placebo-controlled single-ascending dose study in healthy volunteers. The study is expected to enroll approximately 56 healthy adult participants. The primary endpoint is safety, with pharmacokinetics (PK) serving as a secondary endpoint. Interim safety, PK, and ADA data from this trial are expected in the second half of 2025.
About SPY003
SPY003 is an investigational, novel, extended half-life monoclonal antibody targeting IL-23, being developed for the potential 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 dosing regimen; the potential for SPY003 potential to be a best-in-class IL-23 antibody and a compelling combination partner with our anti-α4β7 and anti-TL1A antibodies that can be delivered on a quarterly or bi-annual treatment schedule; the expected participant enrolment of the SPY003 Phase 1 trial; Spyre's future clinical development activities, including its planned Phase 2 trial in ulcerative colitis and timing and design thereof; the potential therapeutic benefits of Spyre's product candidates as monotherapies and or in combination, including the efficacy and convenience of SPY003 compared to the current standard of care in IBD; and the timing and results of clinical trials, including timing of interim safety and PK data readouts for the SPY003 Phase 1 trial. 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," "pipeline," "can," "aim," "strategy," "target," "anticipate," "achieve," "believe," "contemplate," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "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 Form 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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