• PYC developing a drug candidate (PYC-003) for Polycystic Kidney Disease
• Safety Review Committee approved escalation to higher dosing in Phase 1a trial
• Successful review will trigger further dose escalation and initiation of patient dosing

PYC Therapeutics is developing a clinical-stage drug candidate known as PYC-003 for the treatment of Polycystic Kidney Disease (PKD), a condition that affects more than 10 million people worldwide with no available treatment options. The company is currently conducting Part A of a Phase 1a Single Ascending Dose (SAD) study of PYC-003 in healthy volunteers. The Safety Review Committee governing this trial has reviewed the 4-week safety data from the first cohort, which received a 0.4 mg/kg dose, and has approved an escalation in dosing to the second cohort at 1.2 mg/kg. The Safety Review Committee is scheduled to meet again in July to review the 4-week safety data from the second cohort, and a successful outcome is set to trigger further escalation of dosing in healthy volunteers (up to 2.4 mg/kg) as well as the initiation of dosing at 0.4 mg/kg in patients with Polycystic Kidney Disease in Part B of the Phase 1a study. The Phase 1a SAD study will be followed by an Open-Label Extension study and a Phase 1b Multiple Ascending Dose randomized controlled trial to evaluate the safety, tolerability, and efficacy of PYC-003. Successful completion of these Phase 1 studies will lead to the initiation of a registrational combined Phase 2/3 trial aimed at supporting a New Drug Application for PYC-003.

PYC Therapeutics is progressing its clinical development of PYC-003 for Polycystic Kidney Disease, with the next key milestones being the review of the higher dose safety data in July and the potential initiation of patient dosing in the second half of 2025, subject to regulatory approvals.