Business
Aeglea BioTherapeutics Reports Fourth-Quarter and Full-Year 2019 Financial Results, Highlights Recent Milestones
Company Expects to Complete Enrollment in Phase 3 Trial for Patients with Arginase 1 Deficiency in Third Quarter of 2020, with Topline Data Expected in First
About this update from Spyre Therapeutics, Inc.
[{"type":"text","content":"Company Expects to Complete Enrollment in Phase 3 Trial for Patients with Arginase 1 Deficiency in Third Quarter of 2020, with Topline Data Expected in First Quarter of 2021\n Phase 1/2 Trial for Patients with Homocystinuria to Initiate in Second Quarter of 2020 AUSTIN, Texas, Feb. 24, 2020 (GLOBE NEWSWIRE) -- Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing next-generation human enzyme therapeutics as solutions for diseases with high unmet medical need, today reported its fourth-quarter and full-year 2019 financial results, and provided recent corporate and program highlights. “Our accomplishments this past year illustrate how we are working to reimagine the potential of human enzymes as transformative solutions for challenging rare genetic disorders,” said Anthony Quinn, M.B Ch.B, Ph.D., president and chief executive officer of Aeglea. “In addition to delivering compelling Phase 1/2 data from our lead program for Arginase 1 Deficiency, we’ve made solid progress with our pivotal trial enrollment and started laying the groundwork for the commercial launch. We have also continued to make significant progress in our pipeline, further demonstrating the effectiveness of our platform in advancing programs in multiple therapeutic areas.” “We begin 2020 with a clear vision and heightened conviction of the impact for patients we can create with human enzyme therapeutics. We believe that we are well positioned to achieve a number of important milestones this year, armed with a strong leadership team with deep discovery, development and commercial expertise, and driven by our collective goal to address the needs of the communities we serve,” concluded Dr. Quinn. Recent Highlights Pegzilarginase in Arginase 1 Deficiency The Company expects to complete enrollment of its global, pivotal Phase 3 Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints (PEACE) trial in the third quarter of 2020 and to provide topline data in the first quarter of 2021.Based on a recent genetic prevalence analysis of Arginase 1 Deficiency (ARG1-D), and with more than 200 patients already identified worldwide, the Company now estimates an addressable patient population of greater than 2,500, up from an estimate of 1,000 patients based solely on initial insights using newborn screening data.The Company’s patien...