US-based biotechnology company Spyre Therapeutics has begun dosing healthy volunteers in Phase I studies of two investigational monoclonal antibodies.
The drug candidates SPY002-091 and SPY002-072 target the TL1A protein with the aim of treating inflammatory bowel disease (IBD) and other inflammatory and fibrotic diseases.
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Around 56 healthy adult subjects are expected to be enrolled in the first-in-human Phase I trials of the two drug candidates.
The placebo-controlled, double-blind, single-ascending-dose trials aim to evaluate safety as their primary endpoint, with pharmacokinetics (PK) as the secondary endpoint.
Interim results concerning safety, PK and pharmacodynamic (PD) data from the trials are anticipated in the second quarter of next year.
Depending on the outcomes of Phase I trials, Spyre plans to advance the SPY002 programme into Phase II development next year.
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By GlobalDataSpyre Therapeutics CEO Cameron Turtle said: “Entering the clinic with two optimised anti-TL1A molecules is an exciting next step as we build upon our compelling Phase I 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 I success and regulatory feedback, we look forward to introducing one of the SPY002 molecules into our groundbreaking Phase II platform study of monotherapies and combination therapies in ulcerative colitis next year, as well as initiating an efficient Phase II proof-of-concept study outside of IBD.
“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 optimised antibody to initiate clinical trials within nine months.“
IBD is a condition causing gastrointestinal inflammation and mainly consists of ulcerative colitis and Crohn’s disease. It affects an estimated 2.4 million individuals in the US.
Earlier this year, Spyre Therapeutics dosed the first subjects in a Phase I clinical trial of SPY001 for treating IBD.
