Pharmaceutical

Reata Pharmaceuticals (Nasdaq:RETA) a clinical-stage biopharmaceutical company, today provided an update on the ongoing Phase 2 CARDINAL study of bardoxolone methyl (bardoxolone) in patients with chronic kidney disease (CKD) due to Alport syndrome.  The Phase 2 portion of CARDINAL enrolled 30 patients to receive bardoxolone orally, once-daily for two years.  Ninety percent of patients (n=27) …

Reata Pharmaceuticals (Nasdaq:RETA) a clinical-stage biopharmaceutical company, today provided an update on the ongoing Phase 2 CARDINAL study of bardoxolone methyl (bardoxolone) in patients with chronic kidney disease (CKD) due to Alport syndrome.  The Phase 2 portion of CARDINAL enrolled 30 patients to receive bardoxolone orally, once-daily for two years.  Ninety percent of patients (n=27) remain on study and will be included in the Week 52 withdrawal analysis.  Complete data are available through Week 36.

As quoted in the press release:

Efficacy results demonstrate that significant increases in kidney function, as measured by estimated glomerular filtration rate (eGFR), are maintained through Week 36.  The mean improvement from baseline in eGFR at Week 36 is 11.3 mL/min/1.73 m2 (n=27; p<0.0000001), which is not significantly different than the change observed at Week 12.  Initial increases in urinary albumin to creatinine ratio that were due to increases in eGFR have stabilized.  Adverse events have been generally mild to moderate in severity, and no drug-related serious adverse events have been reported.

“Bardoxolone continues to be well-tolerated in Alport syndrome patients as evidenced by the encouraging safety profile and high patient retention rate in the Phase 2 cohort of CARDINAL,” said Colin Meyer, M.D., Chief Medical Officer of Reata.  “These data demonstrate that the clinically meaningful increases in kidney function we observed in Alport syndrome patients after 12 weeks of treatment are durable for at least 36 weeks and consistent with our observations from prior trials of bardoxolone in other forms of CKD.  We appreciate the interest and commitment of the Alport syndrome patient community and CARDINAL investigators to advance our understanding of bardoxolone in these patients with unmet need.”

Click here to read the full press release.

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