• PYC is progressing a drug candidate (PYC-003) that addresses the underlying cause of Polycystic Kidney Disease (PKD)
• The first subject in the Phase 1a trial of PYC-003 has been dosed
• If successful, PYC-003 has a potential high-velocity path to approval with a single combined registrational Phase 2/3 study

PYC Therapeutics Limited (ASX:PYC) has announced that the first subject in a Phase 1a Single Ascending Dose (SAD) study of PYC-003 in healthy volunteers has been dosed with the drug candidate. PYC-003 is a drug candidate that addresses the underlying cause of Polycystic Kidney Disease (PKD). The subject received a 0.4 mg/kg dose of PYC-003 intravenously, and seven additional healthy volunteers will receive either the drug candidate at the same dose or a placebo control over the coming weeks. A meeting of the Safety Review Committee (SRC) overseeing this clinical trial will occur in June/July to review the 4-week follow-up data from all subjects in this cohort and an anticipated request to escalate dosing in cohort 2 of the SAD to 1.2 mg/kg. Part B of this Phase 1a study will evaluate the safety/tolerability and efficacy profile of PYC-003 in patients with PKD, and this part of the trial is expected to commence in Q3 2025. The primary objective of the ongoing Phase 1a SAD study is to evaluate the safety/tolerability profile of PYC-003 with a secondary objective to evaluate the efficacy of the drug candidate when the study moves into PKD patients in 2H 2025.

If successful, PYC-003 has a potential high-velocity path to approval with a single combined registrational Phase 2/3 study expected to follow completion of the ongoing Phase 1a/1b trial.