• PYC has commenced a Phase 1b Multiple Ascending Dose (MAD) study for its PKD drug candidate PYC-003
• The study aims to establish the safety/tolerability profile and evaluate efficacy endpoints including urinary PC1 protein levels, kidney volume, and glomerular filtration rate
• Safety and efficacy data from the ongoing Phase 1a Single Ascending Dose (SAD) study is expected in CY26, with MAD study data in CY27

PYC Therapeutics has announced the initiation of a Phase 1b Multiple Ascending Dose (MAD) clinical trial for its drug candidate PYC-003, which is being developed to address the underlying cause of Polycystic Kidney Disease (PKD). The first PKD patient has now received their first dose of the investigational drug in the open-label MAD study. The objective of this study is to establish the safety and tolerability profile of PYC-003 in a repeat dose setting, as well as evaluate multiple endpoints relevant to the efficacy of the drug candidate, including urinary PC1 protein levels, total kidney volume on MRI, and the estimated glomerular filtration rate. Safety and efficacy data from the ongoing Phase 1a Single Ascending Dose (SAD) study is expected to be presented in the second half of 2026, with data from the Phase 1b MAD study expected to be presented in 2027. Successful completion of the Phase 1b MAD study and alignment with regulatory authorities 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 has not provided any high-importance, price-sensitive forward-looking financial metrics or other company-specific metrics in the announcement.

PYC Therapeutics has stated that successful completion of the Phase 1b MAD study and alignment with regulatory authorities will lead to the initiation of a registrational combined Phase 2/3 trial aimed at supporting a New Drug Application for PYC-003, the Company's drug candidate targeting the underlying cause of Polycystic Kidney Disease (PKD).