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Akebia Announces Initiation of Investigator-Sponsored Study Evaluating Vadadustat for Prevention and Treatment of ARDS in Patients Hospitalized with COVID-19
The University of Texas Health Science Center at Houston to conduct study with up to 300 patients to evaluate use of Akebia's investigational drug,
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"The University of Texas Health Science Center at Houston to conduct study with up to 300 patients to evaluate use of Akebia's investigational drug, vadadustat, as potential therapy to lessen the severity of COVID-19\n\n\nCAMBRIDGE, Mass., July 14, 2020 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, today announced the initiation of an investigator-sponsored study evaluating the use of vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), as a potential therapy to prevent and lessen the severity of acute respiratory distress syndrome (ARDS), a complication of COVID-19 infection. The study will be conducted by The University of Texas Health Science Center at Houston (UTHealth) in Houston, Texas. Bentley J. Bobrow, MD, Chair of Emergency Medicine, and Holger K. Eltzschig, MD, PhD, Chair of the Department of Anesthesiology with McGovern Medical School at UTHealth, will serve as co-principal investigators of the study.\n\n \n \n \n \n \n \n\n \nThe randomized, double-blind, placebo-controlled study is intended to evaluate the safety and efficacy of vadadustat in up to 300 adult patients who have been hospitalized at Memorial Hermann-Texas Medical Center for hypoxemia due to COVID-19, the disease caused by SARS-CoV-2. Patients will be dosed with vadadustat or a placebo starting within 24 hours of hospital admission and continuing for up to 14 days. This study is being conducted under a U.S. Food and Drug Administration Investigational New Drug (IND) application. \n\"The prevalence of COVID-19 in Houston has recently surged and we are excited to be working toward developing better treatment options at UTHealth,\" said Dr. Bentley J. Bobrow. \"Right now, we can support patients with COVID-related ARDS with supplemental oxygen and different forms of ventilation, but don't yet have effective treatments to protect their lungs and help them get better. Our goal is to prevent patients with the virus from progressing to requiring a ventilator and, if they do require a ventilator, to decrease the time they are on that ventilator. We are thrilled to collaborate with Akebia on this study of vadadustat.\" \n\"While Akebia's highest priority remains the continued successful execut...