PKD Clinical Trial - Approval to Escalate Dosing
| Stock | PYC Therapeutics Ltd (PYC.ASX) |
|---|---|
| Release Time | 27 Feb 2026, 8:04 a.m. |
| Price Sensitive | Yes |
PYC Therapeutics Receives Approval to Escalate Dosing in PKD Clinical Trial
- PYC is progressing a drug candidate (PYC-003) to treat the underlying cause of Polycystic Kidney Disease (PKD)
- The company has received approval from the Safety Review Committee to escalate dosing to the third cohort in Part B of the Single Ascending Dose (SAD) study
- The SAD study will be followed by an Open-Label Multiple Ascending Dose (MAD) study to evaluate the optimal dosing regimen
PYC Therapeutics Ltd, a precision medicine company dedicated to changing the lives of patients with genetic diseases, has announced that the Safety Review Committee (SRC) governing the Single Ascending Dose (SAD) clinical trial of its drug candidate PYC-003 has reviewed the 4-week safety data for cohorts B1 and B2 in this study (in PKD patients) and has approved escalation of dosing to cohort B3. PYC-003 is a drug candidate that addresses the underlying cause of Polycystic Kidney Disease (PKD). The SAD study is part of the company's Phase 1a/1b clinical trials for PYC-003, which will be followed by an Open-Label Multiple Ascending Dose (MAD) study to facilitate repeat dosing and evaluate the optimal dosing regimen. Successful completion of the Phase 1a/1b study will lead to the initiation of a registrational combined Phase 2/3 trial aimed at supporting a New Drug Application for PYC-003. PYC will continue to update shareholders on human safety and efficacy data in the program as it becomes available over the coming 24 months.
PYC will continue to update shareholders on human safety and efficacy data in the PYC-003 program as it becomes available over the coming 24 months.