ADOA Program - SRC Approve Progression to Multi-Dose Study
Key points
- PYC progressing investigational drug PYC-001 for blinding eye disease ADOA
- Safety Review Committee approves progression to multi-dose study at 60 microgram dose
- PYC to evaluate safety and efficacy of repeat 60 microgram doses in ongoing Phase 1/2 study
Full summary
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 has announced that the Safety Review Committee (SRC) governing the Phase 1 Single Ascending Dose (SAD) study of PYC-001 has reviewed the 4-week safety and tolerability outcomes for ADOA patients treated with a 60 microgram dose of PYC-001 and approved progression to a multiple dose study at this dose. PYC will now add evaluation of the safety and efficacy profile of repeat doses of 60 micrograms of PYC-001 (alongside the existing 10 and 30 microgram cohorts) in the ongoing Phase 1/2 Multiple Ascending Dose (MAD) study of this drug candidate in patients with ADOA. Data from this ongoing Phase 1/2 MAD study will be presented throughout 2026 and 2027.
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