By Michael Dabaie

Freeline Therapeutics Holdings PLC's American depositary receipts were up 55% to $3.03 premarket Thursday after the company said the U.S. Food and Drug Administration cleared its investigational new drug application for FLT201 as an investigational gene therapy for the treatment of Gaucher disease Type 1.

The clinical-stage biotechnology company said a FLT201 Phase 1/2 trial for Gaucher disease Type 1 is on track for patient dosing in the first half of 2022.

"The FDA clearance of this IND is an important milestone for FLT201, which is the first AAV-mediated gene therapy for patients with Gaucher disease Type 1 in the clinic," Chief Executive Michael Parini said.

Freeline initiated the Phase 1/2 dose-finding trial of FLT201 at the end of 2021 in Europe and expects to dose two patients in the first dose cohort in the first half of 2022, with initial safety and biomarker data from the first cohort expected in the third quarter. The company said it expects to report data on all dosed patients prior to year-end 2022.

Gaucher disease is a genetic disorder in which a fatty substance called glucosylceramide accumulates in macrophages in certain organs.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

01-06-22 0828ET