This article is more than 5 years old. Information may no longer be current.

Phase 2 data show bardoxolone improves kidney function in patients with CKD

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Results from a phase 2 study of bardoxolone methyl in patients with either IgA nephropathy or chronic kidney disease-associated type 1 diabetes showed improvement in eGFR after 12 weeks of therapy, according to a press release from Reata Pharmaceuticals Inc.

Improved kidney function in both cohorts was the primary endpoint of the PHOENIX study, which was conducted by the biopharmaceutical company.

“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 Reata’s chief medical officer Colin Meyer, MD, in a press release. “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.”

In the program, patients received bardoxolone orally once a day for 12 weeks. The primary efficacy endpoint was change from baseline in eGFR after 12 weeks of treatment.

In the IgA nephropathy cohort, patients treated with bardoxolone experienced an increase in eGFR of 8 mL/min/1.73 m² (n=26) at Week 12 compared to baseline. Reata collected historical eGFR data for 23 of these patients, which demonstrated their kidney function was declining at an average annual rate of 1.2 mL/min/1.73 m² prior to study entry, the company said. The observed improvement after 12 weeks of treatment with bardoxolone represents a recovery of approximately 6 years of average eGFR loss, Reata reported.

In the type 1 diabetes cohort, patients treated with bardoxolone experienced a significant increase in eGFR of 5.5 mL/min/1.73 m² (n=28) at Week 12 compared to baseline. Historical eGFR data for 22 of these patients showed kidney function was declining at an average annual rate of 1.9 mL/min/1.73 m² prior to study entry. The observed improvement after 12 weeks of treatment with bardoxolone represents a recovery of approximately 3 years of average eGFR loss, the company said.

No treatment-related serious adverse events were reported in either cohort, and the reported adverse events were generally mild to moderate in intensity, Reata reported.

Reata said in its press release that the FDA has granted orphan designation to bardoxolone for the treatment of Alport syndrome and pulmonary arterial hypertension, and the European Commission has granted orphan designation to bardoxolone for the treatment of Alport syndrome. In addition to PHOENIX, bardoxolone is being studied in CARDINAL, a phase 3 study for the treatment of Alport syndrome; in CATALYST, a phase 3 study for the treatment of connective tissue disease-associated pulmonary arterial hypertension; and in AYAME, a phase 3 study for the treatment of diabetic kidney disease in Japan, the company said.

Reference:

https://reatapharma.gcs-web.com/news-releases/news-release-details/reata-announces-positive-phase-2-data-bardoxolone-methyl-iga