Reata Pharmaceuticals closes CATALYST study of bardoxolone methyl for connective tissue disease-associated pulmonary arterial hypertension .
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.
In consideration of the risk of severe, adverse outcomes associated with COVID-19 among patients with respiratory and autoimmune diseases and after consultation with the study’s Data Safety Monitoring Board (DSMB), the Company has decided to stop the Phase III CATALYST study of bardoxolone methyl (bardoxolone) in patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH). Patients with CTD-PAH have compromised cardiopulmonary function, are often receiving immunosuppressants, and are at an inherently high risk of adverse outcomes in the event of infection. The Company concluded that continued exposure of these high-risk patients to clinic or in-person visits presented an unacceptable risk. The study is not being stopped as a result of any bardoxolone-related safety concern, and the DSMB has not reported any treatment-related safety concern.
An initial review of CATALYST safety data provided by the DSMB suggests that bardoxolone was well-tolerated, with fewer patients discontinuing in the bardoxolone arm compared to the placebo arm. There were no deaths in the bardoxolone arm, and fewer patients reported serious adverse events in the bardoxolone arm compared to the placebo arm. While no futility analyses have been performed, an initial review of available efficacy data provided by the DSMB suggests that the study is unlikely to meet the primary endpoint of improvement in six-minute walk distance compared to placebo at Week 24 .
After the data are formally analyzed, the Company will provide safety and efficacy data for CATALYST at a future medical meeting. Concomitant with the close of CATALYST, the Company is also closing RANGER, the open-label extension study of bardoxolone in patients with PAH.