PYC Therapeutics (ASX:PYC) has dosed the first patient in a Phase 1b Multiple Ascending Dose study testing PYC-003 in people with polycystic kidney disease.
The company said the open-label study will evaluate safety and tolerability in a repeat-dose setting and examine efficacy signals, including urinary PC1 protein levels, total kidney volume on MRI, and estimated glomerular filtration rate.
Data from the related Phase 1a Single Ascending Dose study is expected in the second half of 2026. Data from the ongoing Phase 1b study is expected in 2027.
PYC said successful completion of the Phase 1b study and alignment with regulators would support initiation of a registrational combined Phase 2 and 3 trial aimed at a New Drug Application for PYC-003.