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PHYSICIAN INFORMATION

PHOENIX

“A clinical trial designed specifically for patients with
rare chronic kidney diseases.”

PHOENIX is a multi-center, open-label Phase 2 trial evaluating the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with the following rare chronic kidney diseases (CKD): CKD associated with type 1 diabetes (T1D), IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS), and autosomal dominant polycystic kidney disease (ADPKD).

Reata’s decision to initiate PHOENIX was based, in part, on data from an ongoing study in patients with Alport syndrome, CARDINAL. Initial interim data from the Phase 2 portion of CARDINAL were released in July 2017 and can be found here.

In summary, the available data demonstrate that bardoxolone significantly improved kidney function in Alport syndrome patients as measured by estimated glomerular filtration rate (“eGFR”). From a mean baseline eGFR of 54.7 mL/min/1.73 m2, available data showed a mean improvement of 6.9 mL/min/1.73 m2 at Week 4 (n=19; p<0.0005), increasing to 12.7 mL/min/1.73 m2 at Week 12 (n=8; p<0.00005). Over 80% of patients demonstrated a clinically meaningful improvement in eGFR of at least 3.0 mL/min/1.73 m2 by Week 8, and the 95% confidence interval at Week 12 was 7.9 mL/min/1.73 m2 to 17.5 mL/min/1.73 m2. The observed treatment effect surpasses the threshold of 3.0 mL/min/1.73 m2 that was the minimum effect size necessary to proceed to the Phase 3 portion of the trial. No serious adverse events have been reported in the trial, and reported adverse events have generally been mild to moderate in intensity. The independent data monitoring committee reviewed all available safety data and voted to recommend opening the Phase 3 portion of the trial. Reata’s Bardoxolone Methyl Demonstrated Improved Kidney Function in Patients With Alport Syndrome in Ongoing Phase 2 Portion of Phase 2/3 Cardinal Study (2017)

Due to the rarity of the diseases being studied in PHOENIX, nephrologists and endocrinologists may see only a few patients who could qualify for participation. If you have patients who may qualify, please consider referring these patients by directing the patients to this website. Every patient counts. Your referral can make a difference.

The study team’s involvement with your patients would be exclusively study-specific. If any additional testing is required to confirm a diagnosis, the cost will be covered by Reata. Eligible participants may receive compensation and/or reimbursement for study-related time and travel, including flight or lodging costs.

Bardoxolone Methyl

Bardoxolone methyl (BARD) is an investigational drug in a class of drugs called Nrf2 activators. It is a capsule taken by mouth. Bardoxolone methyl activates Nrf2, a transcription factor that promotes normal mitochondrial function, increases production of antioxidant and detoxification enzymes, reduces oxidative stress, and reduces pro-inflammatory signaling.

Improvements in renal function, including inulin clearance, creatinine clearance, and eGFR, have been observed in clinical studies with bardoxolone methyl treatment in diabetic CKD patients.

Bardoxolone methyl has generally been well-tolerated in most patient populations studied to date. In one previous study, a small subset of Stage 4 CKD patients with type 2 diabetes demonstrated a risk for developing fluid overload adverse events. These patients were subsequently determined to have defined risk factors, including a medical history of heart failure and an elevated BNP level, indicating the presence of fluid retention prior to the study. The increased risk of fluid overload has not been observed in subsequent studies in patients with diabetic CKD or pulmonary hypertension that excluded at-risk patients and carefully monitored their fluid status. In more than 10 of 100 patients, other side effects have been observed with bardoxolone methyl which include: muscle spasms, pain (back, abdominal, extremities), hypomagnesemia, nausea, oedema peripheral (swelling in the limbs), decreased appetite, weight decreases, fatigue, hypoglycemia, and hypertension.

PHOENIX Study Design

Schema for Study of Bardoxolone Methyl in Patients with Rare Chronic Kidney Diseases

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Please consider referring your patients with CKD associated with type 1 diabetes (T1D), IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS), and autosomal dominant polycystic kidney disease (ADPKD) to a PHOENIX research center by sharing this site (PHOENIXclinicaltrial.com) or by submitting an Inquiry Form. A member of the PHOENIX study team will contact you within 48 hours.