PYC Price sensitive 24 Nov 2025, 8:21 AM

PKD Clinical Trial - Approval to Escalate Dosing

PYC Therapeutics Ltd

PKD Clinical Trial - Approval to Escalate Dosing

Key points

  • PYC progressing drug candidate PYC-003 to address underlying cause of Polycystic Kidney Disease (PKD)
  • Approval from Safety Review Committee to escalate dosing to second cohort in Part B of Single Ascending Dose (SAD) study
  • Successful completion of Phase 1a/1b study to lead to registrational combined Phase 2/3 trial

Full summary

PYC Therapeutics Limited (ASX:PYC) is a precision medicine company dedicated to changing the lives of patients with genetic diseases who have no treatment options available. The company currently has three clinical-stage drug development programs, including a drug candidate (known as PYC-003) that addresses the underlying cause of Polycystic Kidney Disease (PKD). PYC today announces that the Safety Review Committee (SRC) governing the Single Ascending Dose (SAD) clinical trial of PYC-003 has reviewed the 4-week safety data from cohort 1 of part B of this study (in PKD patients) and has approved escalation of dosing to cohort 2. The ongoing Phase 1a/1b study aims to evaluate the safety/tolerability profile of PYC-003 and its efficacy in PKD patients. Successful completion of this study will lead to the initiation of a registrational combined Phase 2/3 trial aimed at supporting a New Drug Application for PYC-003.

Outlook

PYC will continue to update shareholders on progress within this high-velocity clinical development program on each of the milestones outlined in this announcement.

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