Business
AVROBIO Reports Fourth Quarter and Fiscal Year 2022 Financial Results and Provides Business Update
Following positive regulatory feedback, plan to initiate registrational global Phase 2/3 clinical trial for Gaucher disease type 3 (GD3) in second half 2023,
About this update from Tectonic Therapeutic, Inc.
[{"type":"text","content":"\nFollowing positive regulatory feedback, plan to initiate registrational global Phase 2/3 clinical trial for Gaucher disease type 3 (GD3) in second half 2023, subject to regulatory alignment\n\nPatient dosing completed in collaborator-sponsored Phase 1/2 clinical trial for cystinosis; plan to initiate late-stage clinical trial activities in second half 2023, subject to regulatory alignment; expect to provide clinical and regulatory update at the American Society of Gene & Cell Therapy (ASGCT) annual meeting in May 2023\n\nPlan to initiate collaborator-sponsored Phase 1/2 clinical trial for mucopolysaccharidosis type II (MPS-II), or Hunter syndrome, in 2023\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAVROBIO, Inc. (Nasdaq: AVRO), a leading clinical-stage gene therapy company working to free people from a lifetime of genetic disease, today reported financial results for the fourth quarter and year ended Dec. 31, 2022 and provided a business update.\n\n“2022 was a transformative year for AVROBIO, topped in December with a robust clinical and regulatory update for our Gaucher disease program. Gaucher disease is one of the most common lysosomal disorders, and the data presented highlighted the potential systemic impact of hematopoietic stem cell (HSC) gene therapy, including data suggesting certain improvements in some significant refractory elements of disease, for people living with Gaucher disease type 1 (GD1) and Gaucher disease type 3 (GD3),” said Geoff MacKay, president and CEO of AVROBIO. “Additionally, we’re excited the collaborator-sponsored Phase 1/2 clinical trial for cystinosis has completed dosing and that data to date show the potential of the HSC gene therapy approach to stabilize or reduce the impact of cystinosis on different tissues throughout the body with a one-time dose. In 2023, we have already started and look forward to continuing to advance our Gaucher disease and cystinosis programs through anticipated near-term milestones.”\n\nProgram Updates\n\nPresented new and encore clinical and preclinical data for AVROBIO’s lysosomal disorder pipeline at the 19th annual WORLDSymposium™, Feb. 22-26, 2023:\n\n\n“Sustained improvement of clinical CNS and somatic features of GD3 after HSC gene therapy: A first-in-world report” -- Clinical data from the first pediatric GD3 patient, dosed with investigational AVR-RD-02, was p...