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Passage Bio (PASG) investor relations material
Passage Bio H.C. Wainwright 27th Annual Global Investment Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Key program highlights
Lead program PBFT02 targets frontotemporal dementia (FTD) with GRN and C9orf72 mutations, affecting about 39,000 patients in the US and Europe.
PBFT02 uses AAV1 capsid for gene therapy, administered via intracisterna magna for broad CNS distribution and lower dosing.
Phase 1/2 trial is open-label, multicenter, with sites in the US, Canada, Portugal, and Brazil; three dosing cohorts planned.
Key biomarkers include CSF progranulin and plasma neurofilament levels, with clinical response measured by a modified dementia rating scale.
Upcoming milestones: regulatory feedback on manufacturing in H2 2025, interim data and registrational trial design in H1 2026.
Clinical data and safety
Dose one showed robust, durable increases in CSF progranulin, exceeding healthy adult levels at 12 and 18 months.
Dose two, at half the level, also reached normal progranulin range at 30 days; all future patients to receive this dose.
Plasma neurofilament levels, a marker of neurodegeneration, increased only 3.7% per year in treated patients vs. 29% in untreated.
Three of eight patients experienced venous thromboembolic events; protocol now includes prophylactic anticoagulation with low-dose apixaban.
No clinically significant immune responses or complications from the administration procedure observed.
Competitive positioning and future plans
PBFT02 achieves higher and more durable progranulin levels than other therapies, including monthly IV antisortillin antibody and another AAV9 gene therapy.
One-time administration is expected to be preferred by patients and families over chronic therapies.
Protocol updates will include earlier-stage patients and exclude more severe cases.
Expansion to FTD C9 patients planned for later this year; preclinical Huntington’s disease program advancing.
Cash balance of $58 million provides runway into Q1 2027.
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