Passage Bio, Inc. ((PASG)) announced an update on their ongoing clinical study.
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Study Overview: Passage Bio, Inc. is conducting a Phase 1b open-label, multicenter, dose-escalation study titled A Phase 1b Open-Label, Multicenter, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacodynamic Effects of a Single Dose of PBFT02 Delivered Into the ICM of Adults With FTD and Mutations in the GRN or C9ORF72 Genes. The study aims to evaluate the safety, tolerability, and pharmacodynamic effects of PBFT02, a gene therapy targeting frontotemporal dementia (FTD) with specific genetic mutations. This research is significant as it explores a novel treatment for a challenging neurodegenerative condition.
Intervention/Treatment: The intervention being tested is PBFT02, a gene therapy designed to deliver a functional copy of the GRN gene to the brain. This treatment aims to address the underlying genetic causes of FTD in patients with mutations in the GRN or C9ORF72 genes.
Study Design: The study is interventional, non-randomized, and follows a sequential model. It is open-label, meaning both researchers and participants know what treatment is being administered. The primary purpose is treatment-focused, with a dose-escalation approach to assess safety and efficacy.
Study Timeline: The study began on February 2, 2021, and is currently recruiting participants. The last update was submitted on October 22, 2025. These dates are crucial as they indicate the study’s progression and ongoing nature, providing a timeline for potential results and implications.
Market Implications: The update on this study could positively influence Passage Bio’s stock performance, as successful development of PBFT02 could position the company as a leader in gene therapy for neurodegenerative diseases. Investors may view this as a promising advancement, especially given the competitive landscape in the biotech industry focused on innovative treatments for dementia.
The study is ongoing, with further details available on the ClinicalTrials portal.