Business
Passage Bio Reports Third Quarter 2020 Financial Results and Recent Business Highlights
– Dosing for first patient in PBGM01 Phase 1/2 trial anticipated in 1Q2021; initial safety and biomarker data expected mid-year 2021 –– Phase 1/2 clinical
About this update from Passage Bio, Inc.
[{"type":"text","content":"– Dosing for first patient in PBGM01 Phase 1/2 trial anticipated in 1Q2021; initial safety and biomarker data expected mid-year 2021 –– Phase 1/2 clinical trials for FTD-GRN and Krabbe expected to initiate in 1H21 –– Completion of dedicated manufacturing suite achieved to ensure control of supply of company’s lead products through early commercialization – – Management to host conference call today at 8:30 a.m. ET –\n PHILADELPHIA, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Passage Bio, Inc. (Nasdaq: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system disorders, today reported financial results for the third quarter ended September 30, 2020 and provided recent business highlights. “Over the past quarter, we have made important strides in strengthening our operations to support the initiation of three Phase 1/2 clinical trials for our lead programs in infantile GM1, FTD-GRN, and Krabbe disease in the first half of 2021,” said Bruce Goldsmith, Ph.D., president and chief executive officer of Passage Bio. “We are particularly pleased with our progress in terms of patient identification, clinical trial site preparedness and manufacturing readiness. We also remain confident that we will receive FDA clearance for our investigational new drug application for PBGM01 for the treatment of infantile GM1. This has all been made possible because of the highly experienced, talented team that we have assembled over the past year to be ready to execute seamlessly in 2021 on our path to providing life-transforming gene therapies for patients with rare, monogenic CNS disorders.” Recent Corporate Highlights Work progresses in anticipation of U.S. Food and Drug Administration (FDA) clearance for investigational new drug (IND) application for PBGM01: In August 2020, Passage Bio received its official letter from FDA confirming that the clinical hold of its IND for PBGM01 for the treatment of infantile GM1 gangliosidosis (GM1) was due solely to questions concerning the biocompatibility of the proposed intra cisterna magna (ICM) delivery device. Passage Bio is working diligently to resolve the clinical hold and, based on feedback from FDA, is conducting biocompatibility risk assessments and testing of the ICM device. The company remains confident that the IND will be cleared. As a result of...