STATISTICALLY SIGNIFICANT IMPROVEMENT IN KIDNEY FUNCTION OBSERVED IN PATIENTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS AFTER 12 WEEKS OF TREATMENT
BARDOXOLONE METHYL SIGNIFICANTLY IMPROVED KIDNEY FUNCTION IN PATIENTS FROM ALL FOUR COHORTS OF PHOENIX
BARDOXOLONE METHYL SIGNIFICANTLY REDUCED BLOOD PRESSURE AND WAS WELL-TOLERATED IN PATIENTS FROM ALL FOUR COHORTS OF PHOENIX
CONFERENCE CALL WITH MANAGEMENT SCHEDULED FOR TODAY,
Patients treated with bardoxolone experienced a significant increase in eGFR of 7.8 mL/min/1.73 m2 (n=18; p=0.003) at Week 12 compared to baseline. Reata collected historical eGFR data for 17 of the 18 patients, which demonstrated that these patients’ kidney function was declining at an average annual rate of 2.6 mL/min/1.73 m2 prior to study entry. The observed 7.8 mL/min/1.73 m2 improvement after 12 weeks of treatment with bardoxolone represents a recovery of three years of average eGFR loss. With respect to safety, no treatment-related serious adverse events were reported, and the reported adverse events were generally mild to moderate in intensity.
“In studies to date, bardoxolone has significantly improved kidney function in a high proportion of patients across six distinct forms of CKD. This supports the hypothesis that bardoxolone addresses a final common pathway of CKD progression,” said
Reata management will host a conference call and webcast to discuss these results on
|CONFERENCE CALL INFORMATION
|Date:||Wednesday, February 20, 2019|
|Time:||8:00 a.m. ET|
|Audience Dial-in (toll-free):||(844) 348-3946|
|Audience Dial-in (international):||(213) 358-0892|
About the PHOENIX Study
The Phase 2 PHOENIX program studied bardoxolone in patients with ADPKD, IgA nephropathy, FSGS, and type 1 diabetic CKD. Patients received bardoxolone open-label, orally, once daily for 12 weeks, and the primary efficacy endpoint was change from baseline in eGFR after 12 weeks of treatment. Endpoints were assessed for each cohort separately.
About Focal Segmental Glomerulosclerosis
FSGS is a rare form of CKD that is characterized by progressive scarring of kidney glomeruli in a focal and segmental pattern, such that not all glomeruli (focal) and only a part of the glomerular tuft (segmental) are affected. Abnormal leakage of proteins through the glomerular basement membrane (GBM) and excessive reabsorption of protein in the proximal tubules of the kidney induce oxidative stress, chronic inflammation, fibrosis, and loss of kidney function. FSGS is one of the most common primary glomerular disorders causing end-stage renal disease and affects approximately 40,000 people in
About Bardoxolone Methyl
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
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.
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding the success, cost and timing of our product development activities and clinical trials, our plans to research, develop and commercialize our product candidates, and our ability to obtain and retain regulatory approval of our product candidates. You can identify forward-looking statements because they contain words such as “believes,” “will,” “may,” “aims,” “plans,” and “expects.” Forward-looking statements are based on Reata’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to; (i) the timing, costs, conduct, and outcome of our clinical trials and future preclinical studies and clinical trials, including the timing of the initiation and availability of data from such trials; (ii) the timing and likelihood of regulatory filings and approvals for our product candidates; (iii) the potential market size and the size of the patient populations for our product candidates, if approved for commercial use, and the market opportunities for our product candidates; and (iv) other factors set forth in Reata’s filings with the
Vice President, Strategy
Matt Middleman, M.D.
LifeSci Public Relations
Source: Reata Pharmaceuticals, Inc.