PYC Therapeutics is advancing its clinical trial for PYC-003, a drug candidate targeting Polycystic Kidney Disease (PKD). The company is escalating the dosage to the fourth and final cohort in its initial Single Ascending Dose (SAD) study, which involves healthy volunteers. PYC Therapeutics is an Australian biotechnology company focused on developing a new generation of precision medicines to change the lives of patients with inherited diseases. Its proprietary drug delivery platform aims to overcome the challenges of safely and effectively delivering RNA therapeutics into the nucleus of cells.
The decision to proceed to the highest dose cohort followed a thorough review of safety data from the first three cohorts by the Safety Review Committee (SRC) overseeing the clinical trials. The SRC’s approval allows PYC to continue dose escalation as planned in the SAD study. Alongside the progression of the single-dose study, PYC has also commenced dosing PKD patients in the subsequent phase of the clinical trial.
These parallel efforts mark significant progress in the development of PYC-003. The company remains on track to initiate repeat dose studies by the fourth quarter of 2025, as previously communicated. The commencement of patient dosing represents a crucial step toward evaluating the drug’s efficacy in the target population.
