PYC-003 Phase 1b polycystic kidney disease study meets enrolment target
PYC Therapeutics (ASX:PYC) has met its interim enrolment target of 24 patients across cohorts C1 (1.2 mg/kg) and C2 (2.4 mg/kg) in the ongoing Phase 1b repeat dose study of PYC-003 in patients with Polycystic Kidney Disease (PKD). The company announced the milestone on 13 November 2026.
PYC-003 addresses the underlying cause of PKD, for patients with PKD caused by a mutation in the PKD1 gene. PYC describes itself as a precision medicine company with three clinical-stage drug development programs.
The company will continue to enrol patients into the Phase 1b study. The milestone positions PYC on track to realise its objective of reading out on 12-month Total Kidney Volume data across a minimum of 24 patients in CY27.
Investors exploring how the study was structured can read our full explainer on the Phase 1b trial design, which covers the dose cohorts, optional expansion cohorts and the three efficacy endpoints of urinary PC1, total kidney volume and eGFR.
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Path to a potentially registrational Phase 2/3 trial
The CY27 Total Kidney Volume read-out is intended to enable progression to a potentially registrational Phase 2/3 trial in CY28. That timeline is subject to regulatory alignment on the proposed registrational study requirements, assumed patient drop-out rates and the risks and uncertainties outlined in the company’s ASX disclosures of 2 February 2026.
Further progression in the ongoing studies is expected to be accompanied by alignment with relevant regulatory authorities on the initiation of a registrational combined Phase 2/3 trial aimed at supporting a New Drug Application for PYC-003 in PKD.
The Open-Label Extension study was designed with a 24-month dosing duration that deliberately mirrors the proposed registrational design, so regulatory considerations were built into the program architecture from the outset.
The next step the company has set out is:
- Data from the ongoing Phase 1b multiple ascending dose (MAD) study of PYC-003 and its associated Open-Label Extension (OLE) study is expected to be presented in CY27, subject to the risks and uncertainties outlined in the company’s ASX disclosures of 2 February 2026.
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