PYC Therapeutics Meets 24-Patient Enrolment Target in Phase 1b PKD Study

Mukul

13 November 2026 10:15 AM AEDT

PYC Therapeutics Meets 24-Patient Enrolment Target in Phase 1b PKD Study

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PYC Therapeutics Limited (ASX:PYC) has announced it has met its interim enrolment target of 24 subjects across cohorts C1 and C2 in its Phase 1b repeat dose study of drug candidate PYC-003 in Polycystic Kidney Disease patients, with the filing dated 13 November 2026.

Key Points

PYC has enrolled the first 24 subjects across cohorts C1 (1.2 mg/kg) and C2 (2.4 mg/kg) of its Phase 1b repeat dose study of PYC-003 in PKD patients
The company said it is on track to read out 12-month Total Kidney Volume data across a minimum of 24 patients in CY27
Progression to a potentially registrational Phase 2/3 trial is targeted for CY28, subject to regulatory alignment and other conditions
Data from the ongoing Phase 1b multiple dose study and its associated Open-Label Extension study is expected to be presented in CY27

Phase 1b Enrolment Milestone in PKD Drug Study

PYC Therapeutics disclosed that it has enrolled 24 subjects across two cohorts in its ongoing Phase 1b study of PYC-003, a drug candidate designed to address the underlying cause of Polycystic Kidney Disease caused by a mutation in the PKD1 gene. Cohort C1 received a dose of 1.2 mg/kg and cohort C2 received 2.4 mg/kg of PYC-003. The company stated it will continue to enrol patients into the Phase 1b study beyond this interim milestone. PYC Therapeutics described itself as a precision medicine company dedicated to patients with genetic diseases who have no treatment options available, and said it currently has three clinical-stage drug development programs.

Twelve-Month Total Kidney Volume Data Readout Targeted for CY27

According to the filing, meeting the 24-patient enrolment target positions the company on track to achieve its objective of reading out on 12-month Total Kidney Volume data across a minimum of 24 patients in CY27. The company stated this data readout is intended to enable progression to a potentially registrational Phase 2/3 trial in CY28. These timelines are subject to regulatory alignment on proposed registrational study requirements, assumed patient drop-out rates, and the risks and uncertainties outlined in the company's disclosures of 2 February 2026.

Proposed Clinical Development Pathway Toward Registrational Trial

The filing states that 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. Data from the ongoing repeat dose studies of PYC-003, including the Phase 1b multiple ascending dose study and the Open-Label Extension study, is expected to be presented in CY27, subject to the risks and uncertainties outlined in the company's prior disclosures. The filing was approved and authorised for release by the Board of PYC Therapeutics Limited.

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