Overview
- MZE782 drove large, dose‑dependent increases in 24‑hour urinary phenylalanine and glutamine, including 39‑fold (single 960 mg) and 42‑fold (240 mg twice daily, Day 7) rises in phenylalanine.
- The oral agent showed predictable pharmacokinetics with a tmax near six hours, an approximately 11‑hour half‑life, and steady state by Day 3, supporting once‑ or twice‑daily dosing.
- Treatment was well tolerated with no serious adverse events or discontinuations reported in healthy volunteers, alongside an initial eGFR dip over seven days that will be monitored in patient studies.
- Two Phase 2 proof‑of‑concept trials are planned for 2026 to test plasma phenylalanine reduction in PKU and proteinuria reduction in chronic kidney disease.
- The oversubscribed private placement totals about $150 million, comprising 4,000,002 shares at $16.25 and 5,231,090 pre‑funded warrants at $16.249, with proceeds earmarked for MZE782, MZE829, research programs, and a resale registration filing within 60 days of closing.