Earnings release
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Exhibit 99.1 AVROBIO Reports First Quarter 2021 Financial Results and Provides Business Update Held meeting with the U.S. Food and Drug Administration ( FDA ) to discuss the regulatory path for AVR - RD - 01 for Fabry disease Dosing completion in ongoing FAB - GT Phase 2 trial reaches 50 % , with three additional patients dosed in three months CAMBRIDGE , Mass . , May 13 , 2021 — - AVROBIO , Inc. ( Nasdaq : AVRO ) , a leading clinical - stage gene therapy company with a mission to free people from a lifetime of genetic disease , today reported financial results for the quarter ended March 31 , 2021 and provided a business update . " During the first quarter , we met with the U.S. Food and Drug Administration ( FDA ) to discuss the regulatory path for AVR - RD - 01 , our investigational gene therapy for Fabry disease . We plan to engage with FDA in the second half of 2021 to seek feedback on our proposal for a registration trial , " said Geoff MacKay , president and CEO of AVROBIO . " In addition , we started the year with strong data updates from all three of our clinical programs - Fabry disease , Gaucher disease and cystinosis - at the WORLDSymposium ™ . These data show sustained improvements across important biomarkers and functional metrics , which we believe support the potential of our lentiviral gene therapy platform to treat life - limiting lysosomal disorders . We have been gratified by the strong interest in our clinical trials , and we're pleased with our progress in enrolling and dosing new patients , including three patients dosed in just the last three months in our FAB - GT trial . As we advance AVR - RD - 01 , we plan to continue to execute across our pipeline , and we look forward to providing future updates . " Program Updates and Milestones Held meeting with FDA to discuss the regulatory_path for AVR - RD - 01 for Fabry disease in the first quarter of 2021 Based on a recent U.S. regulatory development for Fabry disease therapies , AVROBIO intends to discuss with FDA a potential registration trial with a proposed primary efficacy surrogate endpoint of clearance of Gb3 inclusions in biopsied renal peritubular capillaries as the basis for potential full approval . See full update here . Subject to FDA feedback , AVROBIO intends to pursue full approval for investigational AVR - RD - 01 as a first - line therapy for Fabry disease by conducting a single , head - to-