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Akebia Therapeutics Announces Initial Findings from Investigator-Sponsored Clinical Study Evaluating Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Subjects with COVID-19 and Hypoxemia (VSTAT)
CAMBRIDGE, Mass., Aug. 4, 2022 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"CAMBRIDGE, Mass., Aug. 4, 2022 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced initial findings from an investigator-sponsored study evaluating vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the prevention and treatment of ARDS in clinical trial subjects with COVID-19 and hypoxemia (O2 saturation ≤94%). The VSTAT trial (Vadadustat for the Prevention and Treatment of ARDS in Hospitalized Patients with Coronavirus Disease 2019) was a phase 2, randomized, double-blind, placebo-controlled trial, conducted by The University of Texas Health Science Center at Houston (UTHealth) in Houston, Texas and partially funded by Akebia.\n\n \n \n \n \n \n \n\n \nThe trial enrolled 449 adult subjects at five hospitals who were randomized 1:1 to vadadustat 900 mg or placebo once per day orally for up to 14 days while hospitalized. The VSTAT trial measured the proportion of subjects with either 6 (non-invasive ventilation or high flow oxygen devices), 7 (invasive mechanical ventilation or extracorporeal membrane oxygenation), or 8 (death) on the National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS) at Day 7 and Day 14 (primary). While a smaller proportion of subjects in the vadadustat group had a score of 6, 7, or 8 on the NIAID-OS than in the placebo group at Day 14, the trial failed to meet its primary superiority threshold of >95% probability. Those receiving vadadustat; however, did demonstrate 94% probability for conferring benefit on the NIAID-OS at Day 14.\nAt Day 14, the proportions of subjects who had a 6, 7 or 8 on the NIAID-OS were 13.3% (9.6%, 17.7%; 2.5, 97.5 percentiles from Bayesian simulations) for vadadustat versus 16.9% (12.6%, 22.0%) for placebo with a relative risk of 0.79 and 94% probability that vadadustat was superior to placebo. In a pre-specified analysis at Day 7, the proportions of subjects who had a 6, 7 or 8 on the NIAID-OS were 25.4% (20.7%, 30.5%) for vadadustat versus 29.7% (24.5%, 35.3%) for placebo with a relative risk of 0.86 and 97% probability that vadadustat was superior to placebo.\nThe incidence of treatment emergent adverse events was 78.6% in the vadadustat group and 76.2% in the placebo group...