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NEWS
Passage Bio Announces Positive Feedback from FDA on Expansion of upliFT-D Trial of PBFT02 to Include FTD-C9orf72 Patients
Passage Bio (NASDAQ: PASG) has received positive feedback from the FDA on expanding its upliFT-D trial of PBFT02to include FTD-C9orf72 patients. The company plans to amend the ongoing Phase 1/2 global study protocol to introduce this new patient population, with dosing expected to begin in 1H 2025. This expansion is supported by compelling preclinical evidence and safety data from the first cohort of FTD-GRN patients treated with PBFT02.
FTD-C9orf72 affects approximately 21,000 individuals in the US and Europe. The FDA has granted PBFT02 Fast Track and Orphan Drug designations, while the European Commission has also given it Orphan designation. This development could bring new hope to an underserved patient community with clinical trial options.
Passage Bio (NASDAQ: PASG) has received positive feedback from the FDA on expanding its upliFT-D trial of PBFT02to include FTD-C9orf72 patients. The company plans to amend the ongoing Phase 1/2 global study protocol to introduce this new patient population, with dosing expected to begin in 1H 2025. This expansion is supported by compelling preclinical evidence and safety data from the first cohort of FTD-GRN patients treated with PBFT02.
FTD-C9orf72 affects approximately 21,000 individuals in the US and Europe. The FDA has granted PBFT02 Fast Track and Orphan Drug designations, while the European Commission has also given it Orphan designation. This development could bring new hope to an underserved patient community with clinical trial options.
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