Spyre Therapeutics Announces First Participants Dosed in Phase 1 Trials of Novel Half-life Extended Anti-TL1A Antibodies
Spyre Therapeutics (NASDAQ: SYRE) has initiated Phase 1 clinical trials for two half-life extended anti-TL1A antibodies, with first participants already dosed. The SPY002 molecules demonstrate picomolar potency and potential for quarterly or twice-yearly dosing, compared to current first-generation treatments requiring dosing every 2-4 weeks. Interim data is expected in Q2 2025, with plans to advance to Phase 2 studies in ulcerative colitis and beyond IBD. The company maintains a strong financial position with over $630M in proforma cash, providing runway into H2 2028.
Spyre Therapeutics (NASDAQ: SYRE) ha avviato studi clinici di Fase 1 per due anticorpi anti-TL1A a vita utile prolungata, con i primi partecipanti già trattati. Le molecole SPY002 dimostrano una potenza picomolare e un potenziale per dosaggi trimestrali o semestrali, rispetto ai trattamenti di prima generazione attuali che richiedono somministrazioni ogni 2-4 settimane. I dati intermedi sono attesi nel secondo trimestre del 2025, con piani per avanzare agli studi di Fase 2 nella colite ulcerosa e oltre le IBD. L'azienda mantiene una solida posizione finanziaria con oltre $630 milioni in liquidità proforma, garantendo un margine fino alla seconda metà del 2028.
Spyre Therapeutics (NASDAQ: SYRE) ha iniciado ensayos clínicos de Fase 1 para dos anticuerpos anti-TL1A de vida media prolongada, con los primeros participantes ya dosificados. Las moléculas SPY002 muestran una potencia picomolar y un potencial para dosificaciones trimestrales o semestrales, en comparación con los tratamientos de primera generación actuales que requieren dosificación cada 2-4 semanas. Se espera que los datal interinos estén disponibles en el segundo trimestre de 2025, con planes para avanzar a estudios de Fase 2 en colitis ulcerosa y más allá de la EII. La empresa mantiene una sólida posición financiera con más de $630 millones en efectivo proforma, lo que proporciona un margen de maniobra hasta la segunda mitad de 2028.
Spyre Therapeutics (NASDAQ: SYRE)는 두 가지 반감기 연장 항-TL1A 항체에 대한 1상 임상 시험을 시작했으며, 첫 번째 참가자들이 이미 용량을 투여받았습니다. SPY002 분자는 피코몰 수준의 효능을 보여주며, 현재 2-4주마다 투여해야 하는 1세대 치료제에 비해 분기 또는 반기마다 투여할 수 있는 잠재력을 가지고 있습니다. 중간 데이터는 2025년 2분기에 예상되며, 궤양성 대장염 및 기타 염증성 장질환(IBD)에 대한 2상 연구로 나아갈 계획입니다. 회사는 $630M 이상의 프로포르마 현금을 보유하여 2028년 하반기까지의 경과 시간을 보장하는 강력한 재무 상태를 유지하고 있습니다.
Spyre Therapeutics (NASDAQ: SYRE) a lancé des essais cliniques de phase 1 pour deux anticorps anti-TL1A à demi-vie prolongée, les premiers participants ayant déjà été traités. Les molécules SPY002 démontrent une puissance picomolaire et un potentiel de traitements trimestriels ou semestriels, par rapport aux traitements de première génération actuels qui nécessitent une administration toutes les 2 à 4 semaines. Des données intermédiaires sont attendues au deuxième trimestre de 2025, avec des plans pour avancer vers des études de phase 2 dans la colite ulcéreuse et au-delà de la MII. L'entreprise maintient une solide position financière avec plus de 630 millions de dollars en liquidités proforma, assurant ainsi des possibilités jusqu'au second semestre 2028.
Spyre Therapeutics (NASDAQ: SYRE) hat Phase-1-Klinische Studien für zwei halbwertsverlängerte Anti-TL1A-Antikörper eingeleitet, wobei die ersten Teilnehmer bereits behandelt wurden. Die SPY002-Moleküle zeigen eine pikomolare Potenz und das Potenzial für vierteljährliche oder halbjährliche Dosierungen, im Vergleich zu den aktuellen Erstlinienbehandlungen, die alle 2-4 Wochen dosiert werden müssen. Zwischendaten werden im 2. Quartal 2025 erwartet, mit dem Plan, in Phase-2-Studien zur ulzerativen Kolitis und darüber hinaus zur IBD überzugehen. Das Unternehmen hält eine starke finanzielle Position mit über $630 Millionen an Proforma-Cash, die bis in die zweite Hälfte des Jahres 2028 reicht.
- Strong financial position with $630.1M proforma cash balance providing runway into H2 2028
- Successful completion of oversubscribed $230M financing
- SPY002 molecules show improved dosing frequency (quarterly/twice-yearly) vs current 2-4 week standard
- Pipeline expansion with four optimized antibodies in clinical trials within nine months
- No clinical efficacy data available yet for SPY002 molecules
- Phase 1 results not expected until Q2 2025
Insights
The initiation of Phase 1 trials for two anti-TL1A antibodies marks a significant milestone in Spyre's IBD pipeline development. The SPY002 molecules demonstrate key advantages over first-generation treatments with picomolar potency and potential for quarterly or twice-yearly dosing versus current bi-weekly to monthly regimens. This could substantially improve patient compliance and quality of life.
The concurrent advancement of multiple optimized antibodies (SPY001, SPY002, SPY003) shows robust pipeline progression. With
The preclinical data and extended half-life properties suggest potential for superior efficacy and reduced dosing frequency, which could translate to significant market advantages if clinical trials are successful. The expansion beyond IBD into other inflammatory and fibrotic diseases represents additional market opportunities.
The robust cash position of
The development of longer-acting antibodies could capture significant market share in the lucrative IBD space, where current treatments require frequent dosing. The potential for quarterly or twice-yearly dosing could provide a compelling competitive advantage and drive premium pricing. The expansion beyond IBD into other inflammatory conditions represents substantial market expansion opportunities, diversifying revenue potential.
Spyre is concurrently advancing two anti-TL1A molecules into first-in-human studies
Preclinical data for both SPY002 molecules demonstrate picomolar potency and potential for quarterly or twice-yearly dosing, suggesting opportunity for improved efficacy and convenience over first-generation anti-TL1As which are dosed every two to four weeks
Interim pharmacokinetic, pharmacodynamic, and safety data from healthy volunteers for both SPY002 molecules anticipated in the second quarter of 2025
Spyre expects to introduce SPY002 to its planned Phase 2 study in ulcerative colitis exploring quarterly monotherapies and combinations; the Company also intends to initiate a proof-of-concept Phase 2 study outside of IBD in 2025
Strong balance sheet with proforma cash, cash equivalents, and marketable securities balance on September 30, 2024 of over
"TL1A inhibition has demonstrated compelling efficacy in ulcerative colitis and Crohn's disease patients and has been shown in pre-clinical IBD models to provide additive benefit when used in combination with other targeted agents. Further, TL1A is implicated in numerous inflammatory and fibrotic diseases beyond IBD," said Josh Friedman, M.D., Ph.D., SVP of Clinical Development at Spyre. "Our SPY002 molecules were engineered to build upon the evidence from first-generation molecules with optimized properties including picomolar potencies, extended half-lives, and high concentration formulations."
The SPY002 Phase 1 Trials (NCT06672718 and NCT06622070) are double blind, placebo-controlled single-ascending dose studies in healthy volunteers. The studies are each 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 pharmacodynamic (PD) data from these trials are expected in the second quarter of 2025. Pending data from the Phase 1 trials, the Company anticipates progressing the SPY002 program into Phase 2 development in 2025.
"Entering the clinic with two optimized anti-TL1A molecules is an exciting next step as we build upon our compelling Phase 1 results for our next-generation anti-α4β7 antibody, SPY001, which exhibited a greater than 90-day half-life enabling quarterly or twice annual dosing in maintenance. Pending Phase 1 success and regulatory feedback, we look forward to introducing one of the SPY002 molecules into our groundbreaking Phase 2 platform study of monotherapies and combination therapies in ulcerative colitis next year, as well as initiating an efficient Phase 2 proof-of-concept study outside of IBD," said Cameron Turtle, D.Phil., Chief Executive Officer of Spyre. "Both of these studies are fully financed following our recent oversubscribed financing. The first-in-human study for SPY003, our extended half-life IL-23 antibody, remains on track to initiate in the first quarter of 2025, which will mark our fourth optimized antibody to initiate clinical trials within nine months."
The Company had a pro forma cash balance of approximately
About SPY002-091 and SPY002-072
SPY002-091 and SPY002-072 are investigational, extended half-life monoclonal antibodies targeting TL1A for the potential treatment of inflammatory and fibrotic diseases including 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) products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches. Spyre's pipeline includes extended half-life antibodies targeting α4β7, TL1A, and IL-23.
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 of its pipeline and business including, without limitation, the planned dosing regimen for SPY002 molecules, the potential for efficacy improvement and substantial convenience advantage over first-generation anti-TL1As, the therapeutic benefits of its product candidates as monotherapies or in combinations and their picomolar potencies, extended half-lives, and high concentration formulations, the expected design and timing of the platform Phase 2 trial, including the selection of a SPY002 molecule for the planned Phase 2 trial, its plans to conduct its first-in-human study of SPY003, including expected timing thereof, the expected timing for receipt of interim PK, PD and safety data, its plans to initiate a study of SPY002 in indications outside of IBD, including timing thereof, and the sufficiency of its cash runway into the second half of 2028. 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 and clinical trial designs, including the planned Phase 2 trial, to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to regulatory feedback including potential disagreement by regulatory authorities with the Company's interpretation of data and the Company's planned clinical trials for its product candidates, including the Company's planned Phase 2 clinical trial design and 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.
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