Interim Data Demonstrate Significant Improvement in Kidney Function in Both Diseases
Conference Call With Management Scheduled Today,
The ADPKD cohort of
“Bardoxolone has now produced large improvements in kidney function in a high percentage of patients spanning 11 trials and five different forms of chronic kidney disease,” said Dr. Pergola. “These observations suggest that bardoxolone is addressing pathogenic pathways of inflammation and fibrosis that contribute to the loss of kidney function in patients with chronic kidney disease.”
“Bardoxolone’s improvements in kidney function in patients with ADPKD and IgA nephropathy are consistent with improvements observed in other forms of CKD, which have been durable and predictive of retained eGFR benefit after withdrawal of drug in prior trials,” said
Reata management will host a call at
|CONFERENCE CALL INFORMATION|
|Date:||Friday, May 25, 2018|
|Time:||8:00 a.m. ET|
|Audience Dial-in (toll-free):||(844) 348-3946|
|Audience Dial-in (international):||(213) 358-0892|
About Autosomal Dominant Polycystic Kidney Disease
ADPKD is a genetic form of CKD caused by mutations in PKD1 and PKD2 genes leading to inflammation that stimulates the formation of fluid-filled cysts in the kidneys that cause pain and progressive loss of kidney function. ADPKD is the leading inheritable cause of kidney failure with an estimated 116,000 diagnosed patients in
About IgA Nephropathy
IgA nephropathy, also known as Berger’s Disease, is a rare form of CKD that is characterized by deposits of IgA immune complexes in the glomeruli leading to persistent inflammation, oxidative stress, and loss of kidney function. IgA nephropathy is one of the most prevalent primary chronic glomerular diseases with an estimated 120,000 patients in
About the PHOENIX Study
The Phase 2 PHOENIX program is studying bardoxolone in patients with ADPKD, IgA nephropathy, focal segmental glomerulosclerosis, and CKD associated with type 1 diabetes. Patients receive bardoxolone open-label, orally, once-daily for 12 weeks, and the primary efficacy endpoint is change from baseline in eGFR after 12 weeks of treatment. Endpoints will be assessed for each cohort separately.
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 FDA has granted orphan designation to bardoxolone for the treatment of Alport syndrome and for the treatment of connective tissue disease associated pulmonary arterial hypertension.
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 methyl 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 which 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.