Reata Pharmaceuticals Updates Data Release Dates for Ongoing Phase II Trials
Two weeks after Irving, Texas-based Reata Pharmaceuticals, Inc. reported sustained improvements of kidney functions in some patients who have taken bardoxolone methyl (bardoxolone) for two years, the company has updated the timing of coming data announcements for two ongoing mid-stage trials for rare renal diseases.
In its guidance update, Reata said data from its Phase II Phoenix trial will be released in the second half of 2018. The Phoenix trial is assessing the efficacy of bardoxolone in patients with autosomal dominant polycystic kidney disease (“ADPKD”), IgA nephropathy, focal segmental glomerulosclerosis (“FSGS”) and chronic kidney disease associated with type 1 diabetes. The primary endpoint of the trial will be the primary efficacy endpoint is the change from baseline in eGFR after 12 weeks of treatment.
Data from the Phase II/III Cardinal study is expected in the third quarter of 2018, Reata said. The Cardinal trial is studying the efficacy of bardoxolone in patients with CKD caused by Alport syndrome, a genetic disease that causes a progressive loss of kidney function. The Phase II/III study’s primary efficacy endpoint was change from baseline in estimated glomerular filtration rate (eGFR) at week 12.
Reata said results from the 52-week Cardinal study are relevant to the ongoing Phase III portion of the trial. The Phase III study can support accelerated approval by the FDA based upon an improvement in eGFR following 48 weeks of once-daily treatment and 4 weeks of drug withdrawal, Reata said. After this retained benefit analysis, patients will continue on their original study treatment for another 48 weeks, and full approval can be supported by a retained benefit at 104 weeks following a second 4-week drug withdrawal, according to the company.
Reata Chief Medical Officer Colin Meyer said diverse forms of chronic kidney disease are driven by a “common final set of inflammatory pathways” that the company’s drug bardoxolone targets. Bardoxolone methyl is Reata’s oral, once-daily activator of Nrf2, a transcription factor that induces molecular pathways. By doing so it promotes the “resolution of inflammation” by restoring mitochondrial function, reducing oxidative stress and inhibiting pro-inflammatory signaling, according to Reata.
“Treatment with bardoxolone has resulted in clinically meaningful increases in kidney function in patients with Alport syndrome, CKD caused by type 2 diabetes, and CKD associated with pulmonary hypertension, and we hope to demonstrate similar efficacy in these additional types of CKD being studied in PHOENIX. We anticipate that bardoxolone may complement commonly used therapies that modestly affect progression in these diseases, which have no FDA-approved treatments,” Meyer said in a statement.
Earlier this month Reata released data that showed treatment with bardoxolone increased eGFR for two years in patients with pulmonary arterial hypertension which is associated with progressive loss of kidney function. Patients in the two-year study had impaired kidney function when they entered the trial.