Passage Bio, Inc. SEC filings document a clinical-stage genetic medicines issuer focused on PBFT02 for neurodegenerative diseases. Form 8-K reports cover financial results, Regulation FD presentations, PBFT02 clinical and regulatory updates, lease termination matters, and exit or disposal activity affecting operating costs.
Proxy materials disclose board composition, audit committee changes, executive compensation, and equity-award governance. The filing record also identifies the company's public reporting status, Delaware incorporation, Nasdaq listing venue, and recurring capital-resource disclosures tied to development-stage biotechnology operations.
Passage Bio announced updated interim data from their Phase 1/2 upliFT-D clinical trial for PBFT02, targeting frontotemporal dementia with GRN gene mutations (FTD-GRN). Key highlights include:
- Dose 1 PBFT02 showed robust and durable increases in CSF progranulin levels through 18 months post-treatment, reaching mean levels of 23.8 ng/mL at 18 months
- Dose 2 (50% of Dose 1) demonstrated promising early results with CSF PGRN increasing from 1.5 to 7.6 ng/mL
- Plasma neurofilament levels showed only 4% increase at 12 months vs. expected 28-29% in untreated patients
- Safety profile: 5 of 8 patients experienced mild to moderate adverse events; 3 patients had serious adverse events including venous sinus thrombosis and pulmonary embolism
The company plans to amend the trial protocol to include prophylactic anticoagulation and expand to Cohorts 3 and 4. Key upcoming milestones include protocol amendment submission (July 2025), manufacturing process feedback (H2 2025), and updated interim data (H1 2026).