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The COVID-19 pandemic will not have a significant impact on completion of the Phase III CARDINAL trial of bardoxolone for CKD caused by Alport syndrome.- Reata Pharma

Written by | 6 Apr 2020 | COVID-19

Reata Pharmaceuticals, Inc. provided an update on the impact of the COVID-19 pandemic on its clinical programs , drug supply chain, and business operations. The Company announced measures it is taking to protect the health and safety of patients and health care workers involved in ongoing clinical studies of its investigational medicines, as well as its employees and collaborators.

The Phase III CARDINAL trial of bardoxolone in patients with CKD caused by Alport syndrome is fully enrolled and ongoing. During the fourth calendar quarter of last year, the Company reported significant improvements in on- and off-treatment estimated glomerular filtration rate (eGFR) after one year of treatment, which are the primary and key secondary endpoints of the study. After one year of treatment, patients were restarted on the study drug and are continuing for a second year. The Company has implemented the use of at-home visits to collect blood draws and to assess safety as an alternative to in-clinic visits when necessary. The Company has also made arrangements for home delivery of the study drug to patients. At this time, the Company does not believe that the COVID-19 pandemic will have a significant impact on its ability to complete the study or execute on its planned NDA submission for CARDINAL . Patients who participated in the CARDINAL study are eligible to enroll in an open-label extension study known as EAGLE. The Company is implementing procedures for the conduct of EAGLE that are similar to those being using in CARDINAL to ensure continued access to bardoxolone and appropriate safety monitoring.

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