Clinical TrialMay 12, 2026, 04:03 PM
Maze Therapeutics MZE829 Phase 2 Positive; Pivotal Trial Planned
AI Summary
Maze Therapeutics reported positive topline data from its Phase 2 HORIZON trial of MZE829 in broad APOL1-Mediated Kidney Disease (AMKD), demonstrating proof-of-concept and supporting advancement into a pivotal trial in H1 2027. The company also announced plans to initiate two Phase 2 trials for MZE782 in PKU and CKD in 2026. Financially, Maze reported a Q1 2026 net loss of $24.2 million, an improvement from the prior year, and a strong balance sheet with $528 million in cash, cash equivalents, and marketable securities, extending its cash runway into 2029.
Key Highlights
- MZE829 Phase 2 HORIZON trial showed positive topline data in broad AMKD.
- MZE829 achieved 35.6% mean reduction in proteinuria (uACR) at week 12 in broad AMKD.
- MZE829 showed 61.8% mean uACR reduction in severe FSGS patients.
- Pivotal trial for MZE829 in moderate AMKD without diabetes planned for H1 2027.
- Phase 2 trials for MZE782 in PKU and CKD to initiate mid-2026 and H2 2026.
- Cash, cash equivalents, and marketable securities totaled $528 million, extending runway into 2029.
- Q1 2026 net loss was $24.2 million, improved from $32.8 million in Q1 2025.
- Q1 2026 license revenue was $20.0 million, up from $0 in Q1 2025.