Reata Provides Update on the Phase 2 Portion of the CARDINAL Study of Bardoxolone Methyl in Patients With Alport Syndrome
Bardoxolone Treatment Produced Significant Increase in Kidney Function Maintained Through Week 36
Conference Call With Management Scheduled Thursday, April 12th at 8:30am ET
IRVING, Texas, April 11, 2018 (GLOBE NEWSWIRE) — Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (Reata or Company), 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.
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.”
Reata management will host a call to discuss these results on Thursday, April 12th, at 8:30 a.m. ET.
|CONFERENCE CALL INFORMATION|
|Date:||Thursday, April 12, 2018|
|Audience Dial-in (toll-free):||(844) 348-3946|
|Audience Dial-in (international):||(213) 358-0892|
About the CARDINAL Clinical Study
CARDINAL is an international, multi-center, Phase 2/3 study enrolling patients from 12 to 60 years old with a confirmed genetic or histological diagnosis of Alport syndrome, baseline eGFR values between 30 to 90 mL/min/1.73 m2, and on stable renin-angiotensin-aldosterone system blockade unless contraindicated. The Phase 2 portion of CARDINAL is open-label and enrolled 30 patients. The Phase 3 portion of CARDINAL is double-blind, placebo-controlled, and will randomize approximately 150 patients on a 1:1 basis to once-daily, oral bardoxolone or placebo.
The Phase 3 primary efficacy endpoint is the on-treatment eGFR change from baseline in bardoxolone-treated patients relative to placebo at Week 48. The key secondary endpoint of the Phase 3 portion of the trial is the change from baseline in retained eGFR benefit after 48 weeks on-treatment and four weeks off-treatment and is designed to demonstrate that bardoxolone has disease-modifying activity in Alport syndrome patients. Based upon guidance from the United States Food and Drug Administration (FDA), the 52-week retained eGFR benefit data may support accelerated approval under subpart H. After withdrawal, patients will be restarted on study drug with their original treatment assignments and will continue on study for a second year. The second year on-treatment eGFR change will be measured after 100 weeks and the retained eGFR benefit will be measured after withdrawal of drug for four weeks at Week 104. Based upon guidance from the FDA, the year-two retained eGFR benefit data may support full approval.
About Alport Syndrome
Alport syndrome is a rare, genetic form of CKD caused by mutations in the genes encoding type IV collagen, which is a major structural component of the glomerular basement membrane (GBM) in the kidney. The abnormal expression of type IV collagen causes loss of GBM integrity, abnormal leakage of proteins through the GBM, and excessive reabsorption of protein in the proximal tubules of the kidney. Like other forms of CKD, excessive reabsorption of protein in the tubules induces oxidative stress, chronic inflammation, and renal interstitial inflammation and fibrosis.
Alport syndrome affects approximately 30,000 – 60,000 people in the United States according to the Alport Syndrome Foundation. A majority of patients with Alport syndrome develop end-stage renal disease, and approximately 50% of male patients require dialysis or a kidney transplant by the age of 25. There are currently no approved therapies to treat Alport syndrome.
Bardoxolone is an experimental, oral, once-daily activator of Nrf2, a transcription factor that induces molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling. The FDA has granted orphan designation to bardoxolone for the treatment of Alport syndrome and pulmonary arterial hypertension. Bardoxolone is currently being studied in CARDINAL, a Phase 3 study for the treatment of Alport syndrome, and CATALYST, a Phase 3 study for the treatment of connective tissue disease associated pulmonary arterial hypertension.
About Reata Pharmaceuticals, Inc.
Reata is a clinical-stage biopharmaceutical company that develops novel therapeutics for patients with serious or life-threatening diseases by targeting molecular pathways involved in the regulation of cellular metabolism and inflammation. Reata’s two most advanced clinical candidates, bardoxolone and omaveloxolone, target the important transcription factor Nrf2 that promotes the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.
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Matt Middleman, M.D.
LifeSci Public Relations
Source: Reata Pharmaceuticals, Inc.