, /PRNewswire/ -- Spyre Therapeutics, Inc. (NASDAQ: ) (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 its first clinical trial of SPY001, an investigational novel half-life extended anti-α4β7 monoclonal antibody. "The Spyre team has executed efficiently to achieve this milestone within a year of our public launch.
SPY001 is the first of our programs across three of the most impactful mechanisms in IBD, namely α4β7, TL1A, and IL-23, all of which are expected to enter the clinic within the next twelve months," said , D.Phil., Chief Executive Officer of Spyre.
"We look forward to highlighting interim data for SPY001 by the end of this year, which we expect will confirm that SPY001 is well tolerated with a half-life that enables a convenient Q8-12W subcutaneous dosing schedule, with interim data for our T1LA program to follow." The SPY001 is a double blind, placebo-controlled study in healthy volunteers and consists of a single-ascending dose (SAD) component and a multi-ascending dose (MAD) component. The study is expected to enroll approximately 48 healthy adult participants into four SAD cohorts and two MAD cohorts.
The primary endpoint is safety, with pharmacokinetics (PK) s.
