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 $630M following recent oversubscribed $230M financing, providing cash runway into the second half of 2028
WALTHAM, MA, USA I December 2, 2024 I 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 that it has initiated dosing of healthy volunteers in Phase 1 clinical trials of two investigational half-life extended anti-TL1A monoclonal antibodies.
“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 $630.1 million as of September 30, 2024, which includes cash, cash equivalents, and marketable securities as of September 30, 2024 of approximately $414.2 million, plus net proceeds of approximately $215.9 million from the Company’s previously announced underwritten public offering, including the full exercise by the underwriters of their option to purchase additional shares of common stock, and assumes no other changes to cash, cash equivalents and marketable securities since September 30, 2024.
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 the United States, it is estimated that approximately 2.4 million individuals currently have IBD. In head-to-head preclinical studies, SPY002 candidates demonstrated equivalent or better potency to first-generation anti-TL1As and exhibited significantly longer half-lives, with the potential for quarterly or twice-yearly dosing. Spyre is advancing two molecules into Phase 1 trials (NCT06672718 and NCT06622070), and the Company expects interim safety, pharmacokinetic, and pharmacodynamic data 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.
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.
SOURCE: Spyre Therapeutics
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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 $630M following recent oversubscribed $230M financing, providing cash runway into the second half of 2028
WALTHAM, MA, USA I December 2, 2024 I 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 that it has initiated dosing of healthy volunteers in Phase 1 clinical trials of two investigational half-life extended anti-TL1A monoclonal antibodies.
“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 $630.1 million as of September 30, 2024, which includes cash, cash equivalents, and marketable securities as of September 30, 2024 of approximately $414.2 million, plus net proceeds of approximately $215.9 million from the Company’s previously announced underwritten public offering, including the full exercise by the underwriters of their option to purchase additional shares of common stock, and assumes no other changes to cash, cash equivalents and marketable securities since September 30, 2024.
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 the United States, it is estimated that approximately 2.4 million individuals currently have IBD. In head-to-head preclinical studies, SPY002 candidates demonstrated equivalent or better potency to first-generation anti-TL1As and exhibited significantly longer half-lives, with the potential for quarterly or twice-yearly dosing. Spyre is advancing two molecules into Phase 1 trials (NCT06672718 and NCT06622070), and the Company expects interim safety, pharmacokinetic, and pharmacodynamic data 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.
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.
SOURCE: Spyre Therapeutics
Post Views: 818
