Passage Bio announces data from upliFT-D study in FTD-GRN, provides update

Passage Bio (PASG) reported updated data from the ongoing Phase 1/2 upliFT-D clinical trial evaluating PBFT02 for the treatment of frontotemporal dementia with granulin mutations and anticipated upcoming milestones. The company also announced the successful completion of process development and scale-up of a suspension-based manufacturing process for PBFT02. As the PBFT02 program continues to advance, the company reviewed its operating needs and will transition to an outsourced analytical testing model. Update: PBFT02 demonstrated durable, elevated CSF PGRN levels and early evidence of reduction in plasma NfL levels, a disease progression biomarker, compared to published natural history data; Evaluating Dose 2, 50% lower than Dose 1, in subsequent FTD-GRN and FTD-C9orf72 patients to allow for dose exploration and support regulatory strategy; Expect to report 12-month data from Dose 1 and interim safety and biomarker data from Dose 2 in 2H 2025; plan to seek regulatory feedback on FTD-GRN pivotal trial design in 1H 2026; Completed process development and scale-up of a high-productivity, suspension-based manufacturing process for PBFT02.