- Addressing the underlying cause of polycystic kidney disease through clinical trials
- First patient dosed in ongoing MAD study
- OLE of MAD study enables patients to receive drug candidate continuously
- Ongoing Phase 1b study for a period of up to 24 months
Precision medicine company PYC Therapeutics (ASX:PYC) has dosed the first patient in a Part D open-label extension (OLE) of an ongoing Multiple-Ascending Dose (MAD) study of PYC-003 in PKD patients.
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The company currently has three clinical-stage drug development programs, including a drug candidate that addresses the underlying cause of polycystic kidney disease (PKD).
The first patient enrolled in the Open-Label Extension (OLE) of the ongoing Multiple-Ascending Dose (MAD) study in PKD patients.
The patient enrolled in the Part D OLE has completed dosing in the MAD study – meaning that this patient has now been receiving the investigational drug candidate for a period of four months and will continue to receive doses every six weeks for up to 24 months in the OLE.
The objective of the ongoing Phase 1b MAD study is to determine the safety/tolerability profile and optimal dosing regimen in a repeat-dose setting ahead of a proposed transition to a registrational trial for an overview of the proposed clinical development pathway for PYC-0039.
Successful completion of the Phase 1b MAD study followed by alignment with relevant regulatory authorities will lead to the initiation of a registrational combined Phase 2/3 trial aimed at supporting a new drug application.
Data from PYC’s Phase 1a Single Ascending Dose (SAD) study in PKD patients is expected to be presented in H2 CY26. Data from the ongoing Phase 1b MAD study and OLE is expected to be presented in CY27.
Polycystic kidney disease (PKD) is a genetic disorder that causes many fluid-filled cysts to grow in the kidneys. Unlike the usually harmless simple kidney cysts that can form in the kidneys later in life, PKD cysts can change the shape of the kidneys, including making them much larger.
PYC was steady at $2.32 with a Mkt cap of $2.281B.
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