Business
AVROBIO Reports First Quarter 2023 Financial Results and Provides Business Update
On track to initiate registrational global Phase 2/3 clinical trial for Gaucher disease type 3 (GD3) in second half 2023, subject to regulatory alignment
About this update from Tectonic Therapeutic, Inc.
[{"type":"text","content":"\nOn track to initiate registrational global Phase 2/3 clinical trial for Gaucher disease type 3 (GD3) in second half 2023, subject to regulatory alignment\n\n\nPlan to provide clinical and regulatory updates on cystinosis program in conjunction with ASGCT annual meeting in May 2023; plan to initiate late-stage cystinosis clinical trial activities in second half 2023, subject to regulatory alignment\n\n\nCollaborator-sponsored Phase 1/2 clinical trial for mucopolysaccharidosis type II (MPS-II), or Hunter syndrome, initiated\n\n\nAnnounced appointment of current CFO Erik Ostrowski as interim CEO\n\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 first quarter ended March 31, 2023, and provided a business update.\n\n\n“We look forward to building upon last year’s positive data and regulatory updates for our lead programs and demonstrating the potential of our HSC gene therapy approach in the year ahead,” said Erik Ostrowski, interim CEO and current CFO of AVROBIO. “We plan to initiate a global, registrational Phase 2/3 trial of our Gaucher disease type 3 (GD3) program later this year and are happy to report that our collaborator-sponsored Phase 1/2 trial for Hunter syndrome has recently commenced enrollment. Additionally, we plan to provide an update on our cystinosis program in mid-May at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting.”\n\n\nProgram Highlights and Milestones\n\n\nAVR-RD-02 for Gaucher disease:\n\n\n\n“The Guard1 clinical trial – A first in-human, Phase 1/2 study evaluating AVR-RD-02, an HSC gene therapy for Gaucher disease: Preliminary safety, pharmacodynamic and clinical efficacy results from the subjects observed for up to 24 months post-infusion” -- AVROBIO presented safety and efficacy data at the 19th annual WORLDSymposium™, Feb. 22-26, 2023.\n\n\n\nGuard1 is recruiting individuals between the ages of 16 and 50 with Gaucher disease type 1 (GD1), including those who are treatment-naïve and who are stable on enzyme replacement therapy, with sites in Canada and the U.S.\n\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 pe...