PYC Price sensitive 22 Jul 2026, 8:20 AM

PKD - Safety Committee Approves Dose Escalation

PYC Therapeutics Ltd

PYC Therapeutics Announces Dose Escalation Approval for PKD Drug

Key points

  • Safety Committee approves dose escalation to 2.4 mg/kg in Phase 1b study
  • Approval granted based on safety/tolerability data from Phase 1a SAD study
  • Open-Label Extension study approved for up to 24 months of continuous dosing

Full summary

PYC Therapeutics Limited (ASX: PYC) announced that the Safety Review Committee has approved escalation to a higher dose of 2.4 mg/kg in the ongoing Phase 1b Multiple Ascending Dose (MAD) study of PYC-003, a drug candidate for Polycystic Kidney Disease (PKD). This decision follows the review of safety and tolerability data from the Phase 1a Single Ascending Dose (SAD) study and the initial dosing in the Phase 1b MAD study. Additionally, the Company has received approval for an Open-Label Extension (OLE) study to enable continuous dosing of PYC-003 for up to 24 months. Data from the Phase 1a SAD study is expected to be presented in the second half of 2026, while data from the Phase 1b MAD study and OLE is expected in 2027.

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