Spyre Therapeutics has dosed the first subjects in the Phase I clinical trial of SPY001 to potentially treat inflammatory bowel disease (IBD).
The placebo-controlled, double-blind trial is set to enrol approximately 48 healthy adult participants. It will have four single-ascending dose (SAD) and two multi-ascending dose (MAD) cohorts.
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Safety is the trial’s primary endpoint while pharmacokinetics is the secondary endpoint.
The company anticipates reporting interim safety and pharmacokinetic data from the trial by the end of this year.
Based on the data from the Phase I trial, Spyre will advance the asset into the Phase II development stage next year.
SPY001 is a half-life extended anti-α4β7 monoclonal antibody.
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By GlobalDataIt has shown promise in preclinical studies, demonstrating equivalent potency to vedolizumab in blocking MadCAM-1 adhesion.
In addition, it exhibited a significantly longer half-life, suggesting the potential for less frequent dosing, possibly once every two or three months.
Spyre Therapeutics CEO Cameron Turtle said: “SPY001 is the first of our programmes 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 12 months.
“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 programme to follow.”
In November last year, Aeglea BioTherapeutics announced its name change to Spyre Therapeutics. This move was in line with the acquisition of Spyre Therapeutics by Aeglea BioTherapeutics in June.
