Passage Bio, Inc. reported updated interim data from its ongoing Phase 1/2 upliFT-D clinical trial for PBFT02 in FTD-GRN patients. The data demonstrated durable, elevated CSF progranulin (PGRN) levels and early evidence of reduction in plasma neurofilament light chain (NfL) levels, a disease progression biomarker, when compared to published natural history data.
The company announced plans to evaluate Dose 2, which is 50% lower than Dose 1, in subsequent FTD-GRN and FTD-C9orf72 patients to support dose exploration and regulatory strategy. Passage Bio expects to report 12-month data from Dose 1 and interim safety and biomarker data from Dose 2 in the second half of 2025, with plans to seek regulatory feedback on FTD-GRN pivotal trial design in the first half of 2026.
Passage Bio also completed the process development and scale-up of a high-productivity, suspension-based manufacturing process for PBFT02. Furthermore, the company extended its cash runway into the first quarter of 2027 by transitioning to an outsourced analytical testing model and implementing reductions in operating expenses, including a workforce reorganization.
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