Statistically Significant Improvement in Kidney Function Observed in Both Diseases After 12 Weeks of Treatment
Conference Call with Management Scheduled for Today at 8:00 am ET
Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage biopharmaceutical company, today announced positive, final results from the IgA nephropathy and type 1 diabetic chronic kidney disease (T1D CKD) cohorts of PHOENIX, a Phase 2 study of bardoxolone methyl (bardoxolone) in patients with rare forms of CKD. Compared to baseline, bardoxolone significantly improved kidney function as measured by patients’ estimated glomerular filtration rate (eGFR) at Week 12 in both cohorts, which was the primary endpoint of the PHOENIX study.
In the IgA nephropathy cohort of PHOENIX, patients treated with bardoxolone experienced a significant increase in eGFR of 8.0 mL/min/1.73 m2 (n=26; p<0.0001) at Week 12 compared to baseline. Reata collected historical eGFR data for 23 of these patients, which demonstrated that these patients’ kidney function was declining at an average annual rate of 1.2 mL/min/1.73 m2 prior to study entry. The observed 8.0 mL/min/1.73 m2 improvement after 12 weeks of treatment with bardoxolone represents a recovery of approximately six years of average eGFR loss.
In the T1D CKD cohort of PHOENIX, patients treated with bardoxolone experienced a significant increase in eGFR of 5.5 mL/min/1.73 m2 (n=28; p=0.02) at Week 12 compared to baseline. Reata collected historical eGFR data for 22 of these patients, which demonstrated that these patients’ kidney function was declining at an average annual rate of 1.9 mL/min/1.73 m2 prior to study entry. The observed 5.5 mL/min/1.73 m2 improvement after 12 weeks of treatment with bardoxolone represents a recovery of approximately three years of average eGFR loss.
With respect to safety, no treatment-related serious adverse events were reported in either cohort, and the reported adverse events were generally mild to moderate in intensity.
“With these data, bardoxolone has improved kidney function in multiple rare forms of CKD, including Alport syndrome, autosomal dominant polycystic kidney disease, IgA nephropathy, and type 1 diabetic CKD,” said Colin Meyer, M.D., Reata’s Chief Medical Officer. “The absence of drug-related serious adverse events and the eGFR improvements observed in the rare forms of CKD that we have studied suggest that bardoxolone has the potential to become an effective therapy for multiple rare forms of CKD.”
Reata management will host a call to discuss these results today, September 25th, 2018 at 8:00 a.m. ET.
| CONFERENCE CALL INFORMATION | |
| Date: | Tuesday, September 25th, 2018 |
| Time: | 8:00 a.m. ET |
| Audience Dial-in (toll-free): | (844) 348-3946 |
| Audience Dial-in (international): | (213) 358-0892 |
| Passcode: | 9899458 |
| Webcast Link: | https://edge.media-server.com/m6/p/qos423s5 |
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