PKD Clinical Trial - Safety Outcomes in Part A

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Stock PYC Therapeutics Ltd (PYC.ASX)
Release Time 19 Dec 2025, 9:27 a.m.
Price Sensitive Yes
 PYC Therapeutics Announces Safety Outcomes in PKD Trial
Key Points
  • PYC-003 drug candidate for Polycystic Kidney Disease shows safe and well-tolerated results in Phase 1a/1b study
  • Dosing of PKD patients commenced in Part B, repeat dosing in Part C planned for H1 2026
  • Successful completion of Phase 1a/1b to lead to registrational combined Phase 2/3 trial
Full Summary

PYC Therapeutics has announced that the Safety Review Committee governing the Single Ascending Dose (SAD) clinical trial of its PYC-003 drug candidate has confirmed that single doses of PYC-003 up to and including 4 mg/kg in healthy volunteers were considered safe and well-tolerated. The company has commenced dosing PKD patients in cohort 2 (1.2 mg/kg of PYC-003) in Part B of the study and is now preparing for the initiation of repeat dosing in PKD patients in Part C of the study in H1 2026, subject to successful completion of Part B and necessary approvals. The path to market for PYC-003 is expected to consist of the ongoing Phase 1a/1b study, followed by a single registrational combined Phase 2/3 study directed towards supporting a New Drug Application. Successful completion of the Phase 1a/1b study will lead to the initiation of the registrational trial.

Outlook

PYC Therapeutics will continue to update shareholders on progress in the ongoing Phase 1a/1b study, with repeat dose safety and efficacy data expected in 2026.