US-based clinical-stage biopharmaceutical company Reata Pharmaceuticals has started patient screening in a Phase II/III trial of bardoxolone methyl (bard) for the treatment of patients with chronic kidney disease (CKD) caused by Alport syndrome.
Bard is an experimental, oral, once-daily activator of transcription factor Nrf2 that triggers molecular pathways to resolve inflammation, restore mitochondrial function, decrease oxidative stress and prevent pro-inflammatory signalling.
The trial will primarily evaluate the safety and efficacy of bard, as well as examine the patients for improvements in kidney function that are consistent with observations from previous trials in other forms of CKD.
The open-label Phase II portion of the trial will enrol approximately 30 patients from 12 to 60 years of age, with estimated glomerular filtration rates (eGFR) between 30mL/min/1.73m² and 90mL/min/1.73m².
The primary endpoint of this portion is change in eGFR compared to baseline at week 12.
Designed to support regulatory approval, the double-blind, placebo-controlled, randomised Phase III portion will assess dose escalation in approximately 180 patients.
The primary endpoint is the comparitive on-treatment change from baseline in eGFR after 48 weeks and the secondary endpoint is the change from baseline in eGFR following a four-week withdrawal of the drug after one and two years of treatment.
It is expected that the Phase II portion results obtained by the end of this year will form a base for the Phase III portion.
Bard is currently being studied further in a Phase III CATALYST trial to treat patients with connective-tissue disease associated pulmonary arterial hypertension (CTD-PAH).