Clinical-stage biotechnology company Spyre Therapeutics Inc (NASDAQ: SYRE) announced on Monday that it has commenced dosing of healthy volunteers in Phase 1 clinical trials of two investigational half-life extended anti-TL1A monoclonal antibodies.
The double blind, placebo-controlled single-ascending dose studies are being conducted in healthy volunteers, with each trial expected to enrol approximately 56 healthy adults.
Safety is the study's primary endpoint, with a secondary endpoint of pharmacokinetics (PK). Interim safety, PK and pharmacodynamic (PD) data from these trials are expected to be released in the second quarter of 2025.
Pending data from the Phase 1 trials, the company anticipates progressing the SPY002 programme into Phase 2 development in 2025.
Zura Bio announces global Phase 2 TibuSURE trial for systemic sclerosis treatment
Eli Lilly and Co receives approval from FDA for Zepbound
YolTech Therapeutics updates data from Phase I/IIa clinical trial of YOLT-201
AstraZeneca's Tagrisso gains EU approval for advanced lung cancer treatment
Novo Nordisk's CagriSema shows superior weight loss in obesity trial
GSK's Jemperli-Zejula combination shows promise in ovarian cancer
Sapience Therapeutics' ST316 receives US FDA Orphan Drug Designation
Ionis Pharmaceuticals' TRYNGOLZA receives US FDA approval
BioArctic licenses PyroGlu-Aβ antibody programme to Bristol Myers Squibb
Thor Medical signs supply deal with AdvanCell
MOBILion Systems collaborates with Dr Oliver Schmitz to enhance metabolomics analysis
Abilita and Orion partner on antibody therapeutics for oncology and pain
Pharus Diagnostics unveils liquid biopsy test for early pancreatic cancer detection
Mendus reports positive topline data from ovarian cancer trial