• Approval to commence Part B of Single Ascending Dose (SAD) study in Polycystic Kidney Disease (PKD) patients
• Escalating dosing to cohort 3 in Part A of the SAD study in healthy volunteers
• On track to progress to repeat dose studies in PKD patients in Q4 2025

PYC Therapeutics Limited (ASX:PYC) has announced that the Safety Review Committee (SRC) governing the Single Ascending Dose (SAD) clinical trial of its drug candidate PYC-003 for Polycystic Kidney Disease (PKD) has reviewed the safety data from the first two cohorts dosed in Part A of the study (in healthy volunteers) and has approved escalation of dosing to cohort 3. The SRC approval also marks progression into Part B of the study, where PYC will now commence enrolment of PKD patients in the SAD study. PYC's CEO Dr. Rohan Hockings commented that the dose administered in cohort 2 is expected to be at the upper end of the efficacy range in humans based on the pre-clinical data, and establishing safety and tolerability at this dose is an important milestone. PYC has commenced dosing in cohort 3 of Part A of the SAD study and anticipates initiating Part B of this trial in patients with PKD in the immediate future. Parts A and B of the SAD study will be followed by an Open-Label Multiple Ascending Dose (MAD) study and a Phase 1b randomised controlled trial to evaluate the safety, tolerability and efficacy profile of PYC-003. Successful completion of the Phase 1a/1b study will lead to initiation of a registrational combined Phase 2/3 trial aimed at supporting a New Drug Application for PYC-003.

PYC is on track to progress to repeat dose studies in PKD patients in Q4 of 2025 as previously advised.