PYC Therapeutics (ASX:PYC) has completed Dose Range Finding (DRF) studies for its investigational drug, PYC-003, in Non-Human Primates (NHPs).
The company’s PYC-003 drug is designed to address Autosomal Dominant Polycystic Kidney Disease (PKD), a condition affecting 1 in every 1,000 people, and PYC-003 has now shown promising safety and tolerability profiles in preclinical studies.
PKD is characterized by the formation of cysts in the kidneys, leading to progressive kidney damage and, in severe cases, renal failure. With approximately 95% of PKD patients having no available treatment options, there is a significant unmet medical need in this space.
The DRF studies, conducted in NHPs, demonstrated that PYC-003 was safe and well tolerated across all doses evaluated. Importantly, high concentrations of the drug were observed in the target tissue (kidney) at these safe doses, laying a strong foundation for future clinical trials.
PYC-003 holds significant promise as a potential treatment for PKD, with the US Food and Drug Administration outlining a pathway for regulatory approval based on surrogate endpoints. The market for PKD treatments is estimated to be worth over US$10 billion annually.
“These are very encouraging results. We anticipate that the therapeutic dose of PYC-003
in humans is around one-tenth of the highest dose administered in these studies based on the data that we have generated to date,” PYC’s CEO, Dr. Rohan Hocking said.
PYC Therapeutics is now gearing up for Good Laboratory Practice (GLP) toxicology studies for PYC-003, a crucial step toward initiating First In Human (FIH) trials.
The company plans to file a regulatory submission to support FIH studies in Q4 2024, and is on track to deliver initial human data on both safety and efficacy by 2025.
PYC has been trading at 9.6 cents.