PYC Therapeutics (ASX: $PYC) to commence human trials for PYC-001 in ADOA patients

PYC Therapeutics (ASX: $PYC) has received Human Research Ethics Committee (HREC) approval to commence clinical trials of its drug candidate, PYC-001, in patients with Autosomal Dominant Optic Atrophy (ADOA). The company has also lodged a Clinical Trial Notification with the Therapeutic Goods Administration and is set to commence first in human studies of this drug candidate in Australia, with first patient dosing expected to occur this quarter.

PYC's Executive Commentary on Human Trials for PYC-001 in ADOA Patients

PYC Therapeutics is pleased to announce the commencement of human trials for our drug candidate, PYC-001, in patients with Autosomal Dominant Optic Atrophy (ADOA). This significant milestone follows the successful demonstration of the safety and initial efficacy profile of our RNA conjugate modality in a human eye for the first time in our lead Retinitis Pigmentosa type 11 drug program. We are committed to addressing the unmet medical needs of patients suffering from irreversible blinding eye diseases, and we are optimistic about the potential of PYC-001 to provide a disease-modifying treatment option for ADOA patients.

Summary of PYC Therapeutics' Human Trials for PYC-001 in ADOA Patients

PYC Therapeutics (ASX: $PYC) has received HREC approval to commence clinical trials of its drug candidate, PYC-001, in patients with Autosomal Dominant Optic Atrophy (ADOA). The company aims to establish clinical 'proof of concept' data for this drug candidate in 2025, with the goal of initiating a registrational study in 2026. PYC-001, a precision therapy, aims to restore the expression of the OPA1 gene back to levels required for the normal function of the retina. The successful progression of the SAD study will inform the design of the registrational study expected to commence in 2026. PYC Therapeutics is dedicated to creating first-in-class precision therapies for patients with genetic diseases and no treatment options available, and the commencement of human trials for PYC-001 marks a significant step towards achieving this mission.