PYC Therapeutics (ASX:PYC) has announced it is progressing the two-part trial of its PYC-003 for Polycystic Kidney Disease (PKD).
It will commence Part B of the Single Ascending Dose (SAD) study in patients with PKD, and it is escalating dosing to cohort 3 in Part A of the SAD study being conducted in healthy volunteers.
The primary objective of the ongoing Phase 1a SAD study is to evaluate the safety and tolerability of PYC-003, with a secondary objective to evaluate the efficacy of the drug candidate in PKD patients.
The company stated that the progress follows approval from the Safety Review Committee (SRC) after reviewing the safety data for the first two cohorts dosed with PYC-003 in Part A of the SAD study. The dosing of patients with PKD is scheduled to commence in July, and the company said it is on track to progress to repeat-dose studies in PKD patients in the fourth quarter of 2025.
PYC’s CEO, Dr Rohan Hockings, said, “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. Establishing safety/tolerability at a dose that we are happy to progress into pivotal studies is an important milestone.”
The company added that Parts A and B 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.