PYC Therapeutics (ASX:PYC) received all regulatory approvals to start human trials of its drug candidate for polycystic kidney disease, the company said in a Monday Australian bourse filing.
Polycystic kidney disease is a life-changing disease where multiple cysts form throughout a patient's kidney that increase in size over time.
Dosing of patients in the single ascending dose study is expected to be completed in about 12 months with a budgeted cost of AU$10 million, per the filing. The primary endpoint is treatment-emergent adverse events and treatment-emergent serious adverse events.
The initial human safety and efficacy data are anticipated within the year, the filing added.
Company shares were up nearly 3% in recent Monday trade.