Spyre Therapeutics Announces First Participant Dosed in Phase 1 Trial of SPY003, its Novel Half-life Extended IL-23 Antibody
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
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
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
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
View original content to download multimedia:https://www.prnewswire.com/news-releases/spyre-therapeutics-announces-first-participant-dosed-in-phase-1-trial-of-spy003-its-novel-half-life-extended-il-23-antibody-302413345.html
SOURCE