On August 3, 2020 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported plans to report its financial results for the second quarter ended June 30, 2020 on Monday, August 10, 2020 (Press release, Akebia, AUG 3, 2020, View Source [SID1234562709]). In lieu of a second quarter financial results and business update call, Akebia management plans to host a conference call and webcast in early September to report top-line data from PRO2TECT, the second of its two global Phase 3 cardiovascular outcomes programs. The two PRO2TECT studies, which have progressed through database lock, evaluated the efficacy and safety of vadadustat, Akebia’s investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), versus darbepoetin alfa for the treatment of anemia due to chronic kidney disease (CKD) in 3,513 adult patients not on dialysis.
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"The Akebia team, together with all the clinical site staff, did an extraordinary job completing the last patient visits and other work to lock the PRO2TECT database, despite the logistical challenges of operating under the present COVID-19 environment. Locking the database marks an important step toward the completion of our global Phase 3 program for vadadustat, and we look forward to reporting top-line results from the PRO2TECT program in early September," said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics.