• PYC progressing investigational drug candidate PYC-001 for Autosomal Dominant Optic Atrophy (ADOA)
• Safety Review Committee confirms no safety concerns after single dose of PYC-001 in Phase 1 study
• PYC to commence global Phase 1/2 Multiple Ascending Dose (MAD) study in Q4 2025

PYC Therapeutics is progressing an investigational drug candidate (PYC-001) that addresses the underlying cause of a blinding eye disease called Autosomal Dominant Optic Atrophy (ADOA). The company today announces that the Safety Review Committee governing the Phase 1 Single Ascending Dose (SAD) study of PYC-001 has reviewed the 4-week safety and tolerability outcomes for ADOA patients in the third cohort (30 microgram dose) and confirmed that there are no safety concerns following a single dose of PYC-001 at all three doses evaluated in the SAD study. Based on these positive results, PYC is now progressing PYC-001 into a global Phase 1/2 Multiple Ascending Dose (MAD) study that is anticipated to commence in Q4 2025, subject to regulatory and human ethics approval. The objective of the MAD study is to establish clinical proof-of-concept for PYC-001 prior to progression into a global registrational trial directed towards supporting a New Drug Application for PYC-001 in ADOA. ADOA affects 1 in every 35,000 people and there are currently no approved treatment options available for patients.

PYC is now preparing to progress PYC-001 into a global Phase 1/2 Multiple Ascending Dose (MAD) study in patients with ADOA, with the objective of establishing clinical proof-of-concept prior to progression into a global registrational trial directed towards supporting a New Drug Application for PYC-001 in ADOA. The global Phase 1/2 MAD study is expected to commence in Q4 of 2025, subject to regulatory and human ethics approval.