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Aeglea BioTherapeutics Reports Third Quarter 2020 Financial Results and Corporate Highlights
Received U.S. Orphan Drug and Positive Opinion for EU Orphan Drug Designations for ACN00177 Continued Progress in Arginase 1 Deficiency Patient Identification
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[{"type":"text","content":"Received U.S. Orphan Drug and Positive Opinion for EU Orphan Drug Designations for ACN00177\n Continued Progress in Arginase 1 Deficiency Patient Identification and Engagement Efforts\n\n\nAUSTIN, Texas, Nov. 5, 2020 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare and other high-burden diseases, today reported its third quarter 2020 financial results, and provided recent corporate and program highlights.\n\"Although it's been a challenging environment for biotech with the global pandemic, we have continued to be productive in our Arginase 1 Deficiency patient identification and engagement efforts. I am pleased with the progress we are making overall as well as specifically at our PEACE trial sites,\" said Anthony Quinn, M.B Ch.B, Ph.D., president and chief executive officer of Aeglea. \"I am also excited by the momentum we are building in our Homocystinuria program with the recent granting of U.S. Orphan Drug Designation and a positive opinion for EU Orphan Drug Designation for ACN00177.\"\nRecent Highlights and Updates\nPegzilarginase in Arginase 1 Deficiency\nIn September, Aeglea announced the PEACE Phase 3 pivotal trial was more than 50% enrolled with nearly twice the number of patients needed to complete enrollment identified at active trial sites. Enrollment for the trial is anticipated to be completed in January 2021. As of September, Aeglea has identified over 250 Arginase 1 Deficiency patients in addressable markets, a 25% increase relative to the prior year. The number of currently identified patients represents more than 50% and 30% of the estimated genetic prevalence populations in the U.S. and EU5, respectively. ACN00177 in Homocystinuria\nIn October, Aeglea announced the U.S. Food and Drug Administration granted Orphan Drug Designation to ACN00177 for the treatment of Homocystinuria. Additionally, the European Medicines Agency Committee for Orphan Medicinal Products issued a positive opinion recommending Orphan Drug Designation for ACN00177 for the treatment of Homocystinuria in the European Union.Corporate\nIn October, the Company strengthened its financial position with proceeds from shares of common stock sold under its ATM program, resulting in gross proceeds of $25 millio...