PYC Therapeutics (ASX:PYC) said that its safety review committee has approved dose escalation to cohort B3 in the ongoing single ascending dose (SAD) trial of PYC-003, following a review of four-week safety data from polycystic kidney disease (PKD) patients in cohorts B1 and B2, according to a Friday Australian bourse filing.

The trial primarily evaluates safety and tolerability, with efficacy as a secondary endpoint, and if successful, will support initiation of a combined phase 2/3 registrational study toward a new drug application for PYC-003, the filing added.

PYC-003 drug candidate is designed to address and treat the underlying cause of PKD, per the filing.

The SAD study will subsequently transition into an open-label multiple ascending dose phase to evaluate repeat dosing and establish the optimal treatment regimen, the filing said.