Spyre披露SPY072二期RA亚组数据，疗效达部分统计显著但未达到推进RA单药开发内部门槛

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CONFORMED SUBMISSION TYPE: 8-K
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CONFORMED PERIOD OF REPORT: 20260825
ITEM INFORMATION: Regulation FD Disclosure
ITEM INFORMATION: Other Events
ITEM INFORMATION: Financial Statements and Exhibits
FILED AS OF DATE: 20260825
DATE AS OF CHANGE: 20260825
FILER:
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COMPANY CONFORMED NAME: Spyre Therapeutics, Inc.
CENTRAL INDEX KEY: 0001636282
STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834]
ORGANIZATION NAME: 03 Life Sciences
EIN: 464312787
STATE OF INCORPORATION: DE
FISCAL YEAR END: 1231
FILING VALUES:
FORM TYPE: 8-K
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FILM NUMBER: 261315697
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MAIL ADDRESS:
STREET 1: 221 CRESCENT STREET
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20260825160439
ACCESSION NUMBER: 0001636282-26-000105
CONFORMED SUBMISSION TYPE: 8-K
PUBLIC DOCUMENT COUNT: 13
CONFORMED PERIOD OF REPORT: 20260825
ITEM INFORMATION: Regulation FD Disclosure
ITEM INFORMATION: Other Events
ITEM INFORMATION: Financial Statements and Exhibits
FILED AS OF DATE: 20260825
DATE AS OF CHANGE: 20260825
FILER:
COMPANY DATA:
COMPANY CONFORMED NAME: Spyre Therapeutics, Inc.
CENTRAL INDEX KEY: 0001636282
STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834]
ORGANIZATION NAME: 03 Life Sciences
EIN: 464312787
STATE OF INCORPORATION: DE
FISCAL YEAR END: 1231
FILING VALUES:
FORM TYPE: 8-K
SEC ACT: 1934 Act
SEC FILE NUMBER: 001-37722
FILM NUMBER: 261315697
BUSINESS ADDRESS:
STREET 1: 221 CRESCENT STREET
STREET 2: BUILDING 23, SUITE 105
CITY: WALTHAM
STATE: MA
ZIP: 02453
BUSINESS PHONE: 6176515940
MAIL ADDRESS:
STREET 1: 221 CRESCENT STREET
STREET 2: BUILDING 23, SUITE 105
CITY: WALTHAM
STATE: MA
ZIP: 02453
FORMER COMPANY:
FORMER CONFORMED NAME: Aeglea BioTherapeutics, Inc.
DATE OF NAME CHANGE: 20150311
8-K
1
syre-20260825.htm
8-K
syre-20260825
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_______________________________________________________
FORM
8-K
_______________________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
August 25, 2026
_______________________________________________________
SPYRE THERAPEUTICS, INC.
(Exact name of Registrant as Specified in Its Charter)
_______________________________________________________
Delaware
001-37722
46-4312787
(State or Other Jurisdiction
of Incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
221 Crescent Street
Building 23
Suite 105
Waltham
,
MA
02453
(Address of Principal Executive Offices)
(Zip Code)
Registrant’s Telephone Number, Including Area Code:
617
651-5940
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
_______________________________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading
Symbol(s)
Name of each exchange on which registered
Common Stock, $0.0001 Par Value Per Share
SYRE
The Nasdaq Stock Market LLC
(Nasdaq Global Select Market)
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
o
Item 7.01 Regulation FD Disclosure.
SPY072 SKYWAY-RA Sub-Study Topline Results
On August 25, 2026, Spyre Therapeutics, Inc. (“Spyre” or the “Company”) issued a press release announcing topline results from the rheumatoid arthritis (“RA”) sub-study of the Phase 2 SKYWAY basket trial evaluating SPY072 in rheumatic diseases.
A copy of the press release is attached hereto as Exhibit 99.1. The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01 Other Events.
On August 25, 2026, the Company announced topline results from the RA sub-study of the Phase 2 SKYWAY basket trial evaluating SPY072 in rheumatic diseases.
SPY072 SKYWAY-RA Sub-Study Topline Results
The SKYWAY-RA sub-study is one of three sub-studies in the SKYWAY basket trial and is a randomized and placebo-controlled study evaluating two doses of SPY072 in patients with moderate to severely active RA with inadequate response to conventional or advanced therapies. The primary endpoint is the change from baseline to Week 12 in Disease Activity Score in 28 joints, C-reactive protein (DAS28-CRP), and the secondary endpoint is the proportion of patients achieving an ACR20 response at Week 12.
The topline results from the RA sub-study of the Phase 2 SKYWAY basket trial indicated that both SPY072 Low Dose and SPY072 High Dose demonstrated statistically significant benefits compared to placebo on one or more of the primary (change from baseline in DAS28-CRP), key secondary (ACR20), and exploratory endpoints (ACR50). SPY072 was well tolerated, with a safety profile consistent with the TL1A class. The results provide proof-of-mechanism for TL1A in RA and support its potential in other autoimmune diseases and as a combination component, but did not meet the Company’s internal bar to prioritize advancement of SPY072 as a monotherapy in RA.
Efficacy:
SPY072 Low Dose demonstrated a statistically significant benefit compared to placebo on the primary endpoint (change from baseline in DAS28-CRP) at Week 12. Nominally significant improvements versus placebo were observed on the secondary endpoint (ACR20) with High Dose and on the exploratory endpoint (ACR50) with Low Dose. Results were generally comparable between advanced-therapy-naïve and advanced-therapy-experienced sub-groups.
Endpoint (W12)
SPY072 High Dose
(N=48)
SPY072 Low Dose
(N=48)
Placebo
(N=47)
ΔDAS28-CRP
-1.5
-1.9*
-1.3
ACR20
63%**
58%
43%
ACR50
31%
38%**
19%
ACR70
13%
4%
2%
*p<0.05 for SPY072 versus placebo
**nominal p<0.05 for SPY072 versus placebo
Both doses of SPY072 achieved target drug concentrations and provided complete and durable suppression of free TL1A through Week 12, suggesting complete target engagement.
Safety:
SPY072 was well tolerated, with a safety profile consistent with the TL1A class. Rates of adverse events were comparable between active (27%) and placebo (36%) and generally mild or moderate. One Serious Treatment-Emergent Adverse Event (“TEAE”) occurred on each arm, none deemed drug-related. One death occurred in a participant receiving placebo. The most common TEAEs were infections and infestations, occurring in 14% of SPY072-treated participants and 15% of placebo-treated participants.
Next Steps
The Company remains at the forefront of evaluating potential first- and best-in-class monotherapies and combinations in immunology and inflammation (“I&I”) with numerous expected topline readouts over the next 12-18 months to prioritize programs for further development:
Trial
Indication
Asset(s)
Expected timing
SKYLINE Part A
Ulcerative Colitis (“UC”)
SPY003
September 2026
SKYWAY
Psoriatic Arthritis (“PsA”), Axial Spondyloarthritis (“axSpA”)
SPY072
4Q 2026
SKYLINE Part B
UC
SPY001, SPY002, SPY003
SPY120, SPY130, SPY230
2027
SKYLIGHT
Hidradenitis Suppurativa (“HS”)
SPY072 + IL-17A/F
Late 2027 or early 2028
Forward Looking Statements
This Current Report on Form 8-K 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 Current Report on Form 8-K, other than statements of historical fact are forward-looking statements. These statements include, but are not limited to, statements regarding: the efficacy and safety of SPY072/our TL1A antibodies and their potential in other/a range of autoimmune diseases and as combination components; the Company remaining at the forefront of evaluating potential first and best-in-class monotherapies and combinations in I&I; the expected timing of topline results from the PsA and axSpA SKYWAY sub-studies, SKYLIGHT trial in HS and SKYLINE part A and B in UC and the potential further development of these programs; the timing of and the Company’s ongoing development programs in inflammatory bowel disease and HS; and Spyre’s ongoing and future pre-clinical and clinical development activities. The words “opportunity,” “potential,” “milestones,” “pipeline,” “strategy,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “might,” “plan,” “possible,” “predict,” “should,” “will,” “would,” “can,” “likely,” “aim,” and similar expressions (including the negatives of these terms) 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 and involve a number of risks and uncertainties, many of which are beyond Spyre’s control, and 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 to, uncertainties and risks arising from regulatory feedback, including potential disagreement by regulatory authorities with the Company’s interpretation of data and the Company’s clinical trials for its product candidates; the potential for interim data not being delivered within expected time frames or final data not being consistent with or different than the topline or interim data reported for our programs; the potential impact of Trump Administration policies and changes in law on our business; and those uncertainties and factors described in Spyre's most recent Annual Report on Form 10-K, as supplemented and
updated by subsequent Quarterly Reports on Form 10-Q and any other filings that Spyre has made or may make with the Securities and Exchange Commission from time to time. You should not place undue reliance on forward-looking statements in this Current Report on Form 8-K, 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 Current Report on Form 8-K does not purport to summarize all of the conditions, risks and other attributes of an investment in Spyre.
Item 9.01 Financial Statements and Exhibits.
(d)
Exhibits
Exhibit
Number
Description
99.1
Press release issued by Spyre Therapeutics, Inc. regarding Data, dated August 25, 2026.
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
SPYRE THERAPEUTICS, INC.
Date:
August 25, 2026
By:
/s/ Cameron Turtle
Cameron Turtle
Chief Executive Officer
EX-99.1
2
spyre-20260825xexx991.htm
EX-99.1
Document
Exhibit 99.1
Spyre Therapeutics Announces Topline Results from the Rheumatoid Arthritis
Sub-study of the SKYWAY Phase 2 Trial of SPY072
Both doses of SPY072 demonstrated statistically significant benefits compared to placebo on one or more of the primary (change from baseline in DAS28-CRP), key secondary (ACR20), and exploratory endpoints (e.g., ACR50)
SPY072 was well tolerated with rates of adverse events comparable to placebo
Magnitude of effect did not meet the Company’s target to prioritize monotherapy development of SPY072 in rheumatoid arthritis (RA); results support the broad potential of Spyre’s TL1A antibodies in autoimmune disease and as combination components
Topline data for SPY072 in psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) on track for Q4 2026 and for SPY072 in combination with IL17-A/F in hidradenitis suppurativa (HS) in late 2027 or early 2028
WALTHAM, Mass., August 25, 2026 (GLOBE NEWSWIRE)
- Spyre Therapeutics, Inc. (NASDAQ: SYRE), a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients, today announced topline results from the RA sub-study of its Phase 2 SKYWAY basket trial evaluating SPY072 in rheumatic diseases. Both doses of SPY072 demonstrated statistically significant benefits compared to placebo on one or more of the primary (change from baseline in DAS28-CRP), key secondary (ACR20), and exploratory endpoints (ACR50). SPY072 was well tolerated, with a safety profile consistent with the TL1A class. The results provide proof-of-mechanism for TL1A in RA and support its potential in other autoimmune diseases and as a combination component, but did not meet the Company’s internal bar to prioritize advancement of SPY072 in RA.
“The SKYWAY trial was designed to explore the safety and efficacy of TL1A inhibition in a range of rheumatic diseases to identify opportunities for indication-leading products. The results today do not lead us to prioritize SPY072 as a monotherapy in RA. However, the favorable safety profile of TL1A inhibition alongside demonstrated efficacy across inflammatory bowel disease, HS, and now RA provide increased conviction that our long-acting TL1A antibodies have potential in a range of autoimmune diseases and as optimal combination components,” said Cameron Turtle, DPhil, Chief Executive Officer at Spyre. “We want to thank the patients, investigators, and site staff who participated in this study and look forward to results in PsA and axSpA next quarter. Additionally, we are excited to have initiated our SKYLIGHT trial of SPY072 in combination with IL-17A/F in HS, our fourth investigational combination of validated mechanisms in autoimmune indications with high unmet need.”
SKYWAY-RA efficacy results
SPY072 Low Dose demonstrated a statistically significant benefit compared to placebo on the primary endpoint (change from baseline in DAS28-CRP) at Week 12. Nominally significant improvements versus placebo were observed on the secondary endpoint (ACR20) with High Dose and on the exploratory endpoint (ACR50) with Low Dose. Results were generally comparable between advanced-therapy-naïve and advanced-therapy-experienced sub-groups.
Endpoint (W12)
SPY072 High Dose
(N=48)
SPY072 Low Dose
(N=48)
Placebo
(N=47)
ΔDAS28-CRP
-1.5
-1.9*
-1.3
ACR20
63%**
58%
43%
ACR50
31%
38%**
19%
ACR70
13%
4%
2%
*p<0.05 for SPY072 versus placebo **nominal p<0.05 for SPY072 versus placebo
Both doses of SPY072 achieved target drug concentrations and provided complete and durable suppression of free TL1A through Week 12, suggesting complete target engagement.
Safety results
SPY072 was well tolerated with a safety profile consistent with the TL1A class. Rates of adverse events were comparable between active (27%) and placebo (36%) and generally mild or moderate. One Serious TEAE occurred on each arm, none deemed drug-related. One death occurred in a participant receiving placebo. The most common TEAEs were infections and infestations, occurring in 14% of SPY072-treated participants and 15% of placebo-treated participants.
Next steps
The Company remains at the forefront of evaluating potential first- and best-in-class monotherapies and combinations in I&I with numerous expected topline readouts over the next 12-18 months to prioritize programs for further development:
Trial
Indication
Asset(s)
Expected timing
SKYLINE Part A
Ulcerative Colitis
SPY003
Sept 2026
SKYWAY
PsA, axSpA
SPY072
4Q 2026
SKYLINE Part B
Ulcerative Colitis
SPY001, SPY002, SPY003
SPY120, SPY130, SPY230
2027
SKYLIGHT
HS
SPY072 + IL-17A/F
Late 2027 or early 2028
About SKYWAY-RA
The SKYWAY-RA sub-study is one of three sub-studies in the SKYWAY basket trial (NCT07148414) and is a randomized and placebo-controlled study evaluating two doses of SPY072 in patients with moderate to severely active RA with inadequate response to conventional or advanced therapies. The primary endpoint is the change from baseline to Week 12 in Disease Activity Score in 28 joints, C-reactive protein (DAS28-CRP) and the secondary endpoint is the proportion of patients achieving an ACR20 response at Week 12.
About Spyre Therapeutics
Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F as well as rational combination programs.
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. These statements include, but are not limited to, statements regarding: Spyre’s ability to achieve the expected benefits or opportunities with respect to its product candidates and combinations thereof, including its ability to develop next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients; the efficacy and safety of SPY072/ our TL1A antibodies and their broad potential in autoimmune diseases and as optimal combination components; the Company remaining at the forefront of evaluating potential first and best-in-class monotherapies and combinations in I&I; the expected timing of topline results from the PsA and axSpA SKYWAY sub-studies, SKYLIGHT trial in HS and SKYLINE part A and B in UC and the potential further development of these programs; the timing of and the Company’s ongoing development programs in inflammatory bowel disease and HS; and Spyre’s ongoing and future pre-clinical and clinical development activities. The words "opportunity," "potential," "milestones," "pipeline," "strategy," "anticipate," "believe," "could," "estimate," "expect," "may," "might," "plan," "possible," "predict," "should," "will," "would," "can, " "likely," "aim," and similar expressions (including the negatives of these terms) 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 and involve a number of risks and uncertainties, many of which are beyond Spyre’s control, and 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 to, uncertainties and risks arising from regulatory feedback, including potential disagreement by regulatory authorities with the Company’s interpretation of data and the Company’s clinical trials for its product candidates; the potential for interim data not being delivered within expected time frames or final data not being consistent with or different than the topline or interim data reported for our programs; the potential impact of Trump Administration policies and changes in law on our business; and those uncertainties and factors described in Spyre's most recent Annual Report on Form 10-K, as supplemented and updated by subsequent Quarterly Reports on Form 10-Q and any other filings that Spyre has made or may make with the Securities and Exchange Commission from time to time. 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.
For Investors:
Eric McIntyre, Spyre Therapeutics
SVP of Finance and Investor Relations
Eric.mcintyre@spyre.com
For Media:
Josie Butler, 1AB
josie@1abmedia.com
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Aug. 25, 2026
Cover [Abstract]
Document Type
8-K
Entity Registrant Name
SPYRE THERAPEUTICS, INC.
Entity Incorporation, State or Country Code
DE
Entity File Number
001-37722
Entity Tax Identification Number
46-4312787
Entity Address, Address Line One
221 Crescent Street
Entity Address, Address Line Two
Building 23
Entity Address, Address Line Three
Suite 105
Entity Address, City or Town
Waltham
Entity Address, State or Province
MA
Entity Address, Postal Zip Code
02453
City Area Code
617
Local Phone Number
651-5940
Written Communications
false
Soliciting Material
false
Pre-commencement Tender Offer
false
Pre-commencement Issuer Tender Offer
false
Title of 12(b) Security
Common Stock, $0.0001 Par Value Per Share
Trading Symbol
SYRE
Security Exchange Name
NASDAQ
Entity Emerging Growth Company
false
Amendment Flag
false
Entity Central Index Key
0001636282
Document Period End Date
Aug. 25, 2026
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syre-20260825_htm.xml
IDEA: XBRL DOCUMENT
0001636282
2026-08-25
2026-08-25
false
0001636282
8-K
2026-08-25
SPYRE THERAPEUTICS, INC.
DE
001-37722
46-4312787
221 Crescent Street
Building 23
Suite 105
Waltham
MA
02453
617
651-5940
false
false
false
false
Common Stock, $0.0001 Par Value Per Share
SYRE
NASDAQ
false