PYC Aligns with FDA on ADOA Clinical Trial Pathway

PYC Therapeutics (ASX: PYC), a clinical-stage biotechnology firm focused on precision medicines for genetic diseases, has announced its alignment with the US Food and Drug Administration (FDA) regarding the clinical trial pathway for its investigational drug candidate addressing Autosomal Dominant Optic Atrophy (ADOA), a blinding eye disease affecting approximately 1 in every 35,000 people. The ADOA market is estimated at AU$2 billion annually, with no current treatment options. Following a pre-Investigational New Drug (pre-IND) meeting, PYC expects to progress the drug candidate to human trials in the first half of 2024.

This milestone marks the second first-in-class drug program that PYC has advanced into clinical studies, as the company strives to bring a third disease-modifying potential drug into human trials by the end of 2024. ADOA is caused by a mutation in the OPA1 gene, leading to insufficient gene expression and vision loss. PYC's investigational drug, PYC-001, aims to restore OPA1 gene expression using precision therapy and proprietary drug delivery technology.

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