Maze Therapeutics (MAZE) investor relations material

Program updates and clinical development

• Multiple clinical programs are advancing, including MZE829 for APOL1-mediated kidney disease and MZE782 targeting SLC6A19, with phase 2 studies planned for PKU and CKD later this year.

• Data for MZE829 is expected later this quarter, with additional studies for MZE782 starting later in the year.

• MZE829 aims to demonstrate at least a 30% reduction in UACR as clinical proof of concept, potentially leading to a registrational study.

• Patient recruitment has benefited from increased disease awareness and improved diagnostic tools, such as standard genotyping panels and new ICD-10 codes.

• The company plans to report both UACR and UPCR data, with UACR as the primary efficacy measurement.

Mechanistic insights and differentiation

• MZE829 is designed to both block and disrupt the assembly of APOL1 pores, addressing a key disease mechanism more comprehensively than competitors.

• The approach combines in vitro thallium flux assays with in vivo BAC transgenic mouse models for dose selection, aiming for broader efficacy.

• The dual mechanism is believed to offer advantages over therapies that only block the pore, potentially leading to better clinical outcomes.

Regulatory and clinical strategy

• The registrational pathway may involve a phase 2b study using proteinuria reduction and eGFR slope as endpoints for accelerated approval.

• The company intends to leverage data and regulatory precedents set by other sponsors and academic groups to inform its approval strategy.

• Data readouts will include both mean and individual patient responses to support confidence in clinical proof of concept.