• PYC progressing drug candidate PYC-003 to address underlying cause of Polycystic Kidney Disease (PKD)
• Approval to escalate dosing to final cohort in Part A of Single Ascending Dose (SAD) study in healthy volunteers
• Commenced dosing of PKD patients in Part B of combined Phase 1a/1b study

PYC Therapeutics is progressing a drug candidate (PYC-003) that addresses the underlying cause of Polycystic Kidney Disease (PKD) through clinical trials. The company has announced that the Safety Review Committee governing the Single Ascending Dose (SAD) clinical trial of PYC-003 has reviewed the 4-week safety data from cohort 3 of part A of this study (in healthy volunteers) and has approved escalation of dosing to cohort 4, which is the final cohort. PYC has also commenced dosing of PKD patients in Part B of the SAD study. Part A of the SAD study will be followed by an Open-Label Multiple Ascending Dose (MAD) study facilitating repeat dosing and evaluation of the optimal dosing regimen of PYC-003. This study will be conducted alongside 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.