PYC Therapeutics progresses drug candidate for blinding eye disease

PYC Therapeutics (ASX: $PYC) has successfully completed Good Laboratory Practice (GLP) toxicology studies in Non-Human Primates (NHPs) for its drug candidate, PYC-001, aimed at addressing Autosomal Dominant Optic Atrophy (ADOA). The results have cleared the path for the drug to enter human trials, with a Single Ascending Dose (SAD) study planned to provide initial human safety and efficacy data in 2025.

Executive Commentary on PYC-001 Progression

The successful completion of the GLP toxicology studies in NHPs for PYC-001 is a significant milestone for PYC Therapeutics. The safety profile established paves the way for the regulatory submission to enable human trials to commence. We are optimistic about the potential of PYC-001 to address the underlying cause of ADOA, a blinding eye disease affecting a significant number of individuals with no available treatments. The progression into human trials marks a crucial step forward in our mission to develop precision medicines for genetic diseases with unmet medical needs.

Summary of PYC Therapeutics Announcement

PYC Therapeutics (ASX: $PYC) has achieved a major milestone with the successful completion of GLP toxicology studies for its drug candidate, PYC-001, targeting Autosomal Dominant Optic Atrophy (ADOA). The results have demonstrated the safety and well-tolerated nature of PYC-001, clearing the path for the drug to progress into human trials. The Company aims to conduct a Single Ascending Dose (SAD) study to provide initial human safety and efficacy data in 2025, with a planned New Drug Application in 2028. The potential market for ADOA treatment is estimated to be over $2 billion annually, highlighting the significant impact of PYC-001's successful progression. PYC Therapeutics continues to focus on developing precision medicines for genetic diseases, with ongoing efforts to bring innovative therapies to patients in need.