Advertisement
Passage Bio Says New Interim Data From Imagine-1 Clinical Study Strengthens Safety Profile Of PBGM01
(RTTNews) - Genetic medicines company Passage Bio, Inc. (PASG) announced on Wednesday new interim safety, biomarker, and clinical development results from cohorts 1-3 in the Imagine-1 clinical study.
Imagine-1 is a Phase 1/2, global, open-label, dose-escalation study of the AAVhu68 gene therapy PBGM01 delivered by intra-cisterna magna (ICM) injection in four cohorts of pediatric subjects with early and late infantile GM1 Gangliosidosis (GM1).
GM1 is a rare, fatal lysosomal storage disease in which mutations in the GLB1 gene result in very low activity of the enzyme beta-galactosidase (ß-Gal).
The interim data include six treated patients from the first three cohorts. Cohort 1 (late infantile, low dose), Cohort 2 (late infantile, high dose) and Cohort 3 (early infantile, low dose) each consisted of two patients. Cohort 4 (early infantile, high dose) patients have been dosed and data is expected by mid-2023.
The company noted that new interim data from cohorts 1-3 continue to strengthen the favorable safety profile of PBGM01, with no treatment-related serious adverse events, no complications related to ICM administration and no evidence of DRG toxicity.
Passage has completed dosing of PBGM01 in the dose-escalation portion of the study and will evaluate dosing further patients at the current high dose and/or a higher dose as data from cohorts 1-4 mature.
For More Such Health News, visit rttnews.com
U.S. Pending Home Sales Unexpectedly Spike 6.1% March
U.S. Consumer Prices Virtually Unchanged In March, In Line With Estimates
Chicago Business Barometer Drops More Than Expected In April
U.S. GDP Unexpectedly Dips In First Quarter As Imports Soar
U.S. Private Sector Job Growth Falls Well Short Of Expectations In April
Eurozone GDP Growth Gains Strength In Q1
U.S. GDP Unexpectedly Dips 0.3% In First Quarter
