Freeline doses first patient in Phase 1/2 GALILEO-1 trial of FLT201

Freeline Therapeutics announced that the first patient has been dosed in the Phase 1/2 GALILEO-1 clinical trial evaluating FLT201, its adeno-associated virus gene therapy candidate, in Gaucher disease type 1. Gaucher disease is a debilitating genetic disorder in which a deficiency of the GCase enzyme leads to a buildup of fatty substances in the organs, causing symptoms including enlarged spleen and liver, low blood counts, bone pain and reduced lung function. GALILEO-1 is a first-in-human, international, multicenter Phase 1/2 dose-escalation study. The trial will assess safety, tolerability and efficacy of a single intravenous dose of FLT201 in up to four cohorts of escalating doses, with the aim of identifying a dose for further development in a Phase 3 clinical trial. Visit clinicaltrials.gov to learn more about GALILEO-1. Freeline expects to report initial data, with a focus on safety and enzyme activity, from the first cohort of GALILEO-1 in the third quarter of this year.