PYC Therapeutics (ASX:PYC) has announced that it has received all required regulatory approvals to commence human clinical trials of PYC-003.
The company said it would now proceed to initiate a Single Ascending Dose (SAD) study of PYC-003 in healthy volunteers (Part A) and Polycystic Kidney Disease (PKD) patients.
PKD is a life-changing disease characterised by multiple cysts forming throughout a patient's kidney that increase in size over time. The growth of the cysts destroys the architecture and ultimately function of the kidney, eventually leading to end-stage renal failure and the need for organ transplantation in the majority of patients by the age of 55. PKD affects approximately one in every 1,000 people and represents a major unmet need in medicine.
The study's primary endpoint will be treatment-emergent adverse events and treatment-emergent serious adverse events. The study will also collect data on exploratory endpoints directed towards efficacy of the drug candidate, including urinary biomarkers.