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Reata and Abbott Announce Positive Phase 2b Study Results for Bardoxolone Methyl: kidney anti-inflammation drug
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"Bardoxolone methyl is an antioxidant inflammation modulator (AIM) that activates Nrf2, thereby inducing the transcription of genes that decrease the level of oxidative stress and suppress important inflammatory mediators. In two Phase 2a studies, bardoxolone methyl was shown to increase measures of kidney function in patients with moderate to severe CKD and Type 2 diabetes. "
Results Suggest Bardoxolone Methyl May Reduce the Stage of Disease and Improve Measures of Kidney Function in Patients with Chronic Kidney Disease and Type 2 Diabetes
Late-Breaking Clinical Data Presented at
American Society of Nephrology Renal Week Conference
IRVING, Texas and ABBOTT PARK, Ill., Nov. 20, 2010 -- Reata Pharmaceuticals and Abbott today announced data from a Phase 2b study which suggests that bardoxolone methyl, an investigational treatment for chronic kidney disease (CKD), may reduce the stage of CKD and improve estimated glomerular filtration rate (eGFR) and other measures of kidney function in the majority of patients receiving the drug. The data were presented today in a late-breaking oral presentation at the American Society of Nephrology (ASN) Renal Week Conference in Denver, Colorado.
The study evaluated patients with moderate (stage 3b) to severe (stage 4) CKD and type 2 diabetes. Approximately 60 percent of the patients receiving bardoxolone methyl experienced a reduction in the classification of the severity of their disease after 24 weeks of treatment. Only 17 percent of patients in the placebo group experienced such a reduction. Additionally, only four percent of patients in each bardoxolone methyl group experienced a worsening of CKD stage compared to 13 percent in the placebo group.
"Chronic kidney disease is a significant health problem in the U.S., as the standard of care slows but does not reverse progression of the disease," said Pablo Pergola, M.D., Ph.D., Research Director for Renal Associates PA and Clinical Associate Professor of Medicine at the University of Texas Health Science Center at San Antonio, who presented the data. "These encouraging results suggest that bardoxolone methyl has the potential to change the treatment landscape of chronic kidney disease and offer new hope for these patients and their families."
The multi-center, randomized, double-blind clinical trial enrolled 227 CKD patients with type 2 diabetes who were randomized to receive once-daily doses of placebo or 25, 75 or 150 mg doses of bardoxolone methyl. The primary endpoint of the study was change in estimated GFR following 24 weeks of treatment.
At week 24, patients treated with bardoxolone methyl experienced a mean increase in estimated GFR of over 10 mL/min/1.72m2, compared with no change in the placebo group. Approximately three-quarters of bardoxolone methyl-treated patients experienced an improvement in eGFR of 10 percent or more, including one-quarter who saw an improvement of 50 percent or more compared to less than two percent of patients on placebo. (p<0.001).
The frequency of adverse events was higher in the bardoxolone methyl group compared to the placebo group, with most events mild to moderate in severity. The most frequently reported adverse event in the bardoxolone methyl group was muscle spasm.
"We are very pleased to see that bardoxolone methyl reduced the stage of disease and improved measures of kidney function in the majority of patients receiving the drug," said Warren Huff, CEO of Reata. "We are hopeful that these results will be further validated at the end of the study, and we look forward to initiating a Phase 3 study in the first half of 2011."
"Extensive preclinical and clinical experience with bardoxolone methyl have suggested this drug holds promise as a new approach for the treatment for CKD -- one that has the potential to help prevent patients from progressing to the later stages of the disease and dialysis," said Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott. "We look forward to expanding our knowledge further in future studies."
About Bardoxolone Methyl
Bardoxolone methyl is an antioxidant inflammation modulator (AIM) that activates Nrf2, thereby inducing the transcription of genes that decrease the level of oxidative stress and suppress important inflammatory mediators. In two Phase 2a studies, bardoxolone methyl was shown to increase measures of kidney function in patients with moderate to severe CKD and Type 2 diabetes.
About Chronic Kidney Disease
Chronic kidney disease (CKD) is a progressive loss of kidney function over a period of months or years, which can be caused by a number of conditions, including diabetes and high blood pressure. Diabetes is one of the leading causes of CKD. CKD is a highly prevalent condition, worldwide, with numbers expected to rise over the next decade. Available therapies modestly slow the progression of CKD, and patients ultimately progress to dialysis.
About Reata Pharmaceuticals
Reata Pharmaceuticals is the leader in discovering and developing novel, oral anti-inflammatory drugs that activate Nrf2, the primary regulator of cellular antioxidant and detoxification enzymes. Activation of this important biological target protects against a broad range of diseases associated with inflammation and oxidative stress. Reata is developing bardoxolone methyl, its lead product candidate, as the first disease-modifying treatment for chronic kidney disease. In January 2010, Reata and Kyowa Hakko Kirin announced a licensing agreement providing KHK with the exclusive rights to develop and commercialize bardoxolone in Japan and other selected Asian markets. In September 2010, Reata formed a strategic partnership with Abbott for the commercialization of bardoxolone in other ex-U.S. markets. Reata retains exclusive rights to bardoxolone in the U.S.
For more information please visit the company's Web site at
www.reatapharma.com.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacturing and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at www.abbott.com.
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Reata contacts
Media: Heidi Chokeir, heidi.chokeir@russopartnersllc.com, 1-619-528-2217
Investors: Alan Roemer, aroemer@troutgroup.com, 1-646-378-2945
Abbott contacts
Media: Tracy Sorrentino, tracy.sorrentino@abbott.com, 1-847-937-8712
Financial: Larry Peepo, larry.peepo@abbott.com, 1-847-935-6722
Press Release
Abbott and Reata Pharmaceuticals Announce Agreement to Develop and Commercialize Bardoxolone Methyl for Chronic Kidney Disease Outside the U.S.
Date: September 23, 2010
Abbott Park, Illinois and IRVING, Texas - Abbott and Reata Pharmaceuticals today announced that they have entered into a collaboration agreement to develop and commercialize bardoxolone methyl (bardoxolone), which is currently in late Phase 2 trials for the treatment of chronic kidney disease (CKD).September 23, 2010
Under terms of the agreement, Reata will grant to Abbott exclusive rights to develop and commercialize bardoxolone outside the U.S., excluding certain Asian markets. Reata will receive upfront and near-term cash payments of $450 million for the licensing rights to bardoxolone and a minority equity investment in the company. Upon completion of certain development and approval objectives for bardoxolone and other molecules in the licensed territories, Reata will receive additional milestone payments. Reata also will receive royalties on any future product sales in the Abbott territories. Additionally, Abbott obtains rights to develop and commercialize certain other Reata compounds for chronic kidney disease, and for cardiovascular and metabolic indications, in these territories.
"Early clinical studies suggest that bardoxolone could be a significant improvement to the current standard of care for CKD and possibly prevent patients from progressing to the later stages of the disease and dialysis," said John Leonard, M.D., senior vice president, pharmaceuticals, research and development, Abbott. "This agreement builds on Abbott's existing experience in renal care, while adding a promising compound to our later-stage pipeline."
Bardoxolone is an oral, first-in-class antioxidant inflammation modulator that works by increasing the estimated glomerular filtration rate (eGFR) of the kidneys. In two Phase 2 clinical trials, bardoxolone significantly improved kidney function in patients with advanced CKD and Type 2 diabetes. CKD currently affects more than 50 million adults worldwide, and the number of patients is rapidly increasing throughout the world.
"Reata is very pleased to have Abbott as our partner and believe that its existing renal capabilities will be a great asset to the global program," said Warren Huff, chief executive officer of Reata. "This partnership allows us to meet our strategic goal of establishing our own commercial presence in the U.S. and building a sustainable, fully integrated pharmaceutical company."
This transaction does not impact Abbott's previously issued ongoing earnings-per-share guidance for 2010. Abbott expects to incur one-time specified items in the fourth quarter of 2010, primarily related to in-process research and development.
About Bardoxolone Methyl
Bardoxolone methyl is an antioxidant inflammation modulator (AIM) that activates Nrf2, thereby inducing the transcription of more than 250 genes that decrease the level of oxidative stress and suppress several inflammatory mediators. In two Phase 2a studies, bardoxolone methyl was shown to produce a statistically significant increase in estimated glomerular filtration rate as well as improvements in other key markers of renal function in Stage 3b and 4 CKD patients with Type 2 diabetes.
About Chronic Kidney Disease and Diabetic Kidney Disease (Nephropathy)
CKD is a highly prevalent condition, affecting more than 50 million adults around the world. Half of CKD patients also have diabetes, a percentage that is expected to grow as rates of diabetes increase. Diabetes is the leading cause of CKD, with as many as 30 to 40 percent of Type 2 diabetics developing the disease. Available therapies modestly slow the progression of CKD, and patients ultimately progress to dialysis.
About Reata Pharmaceuticals
Reata Pharmaceuticals is the leader in discovering and developing novel, oral anti-inflammatory drugs that activate Nrf2, the primary regulator of cellular antioxidant and detoxification enzymes. Activation of this important biological target protects against a broad range of diseases associated with inflammation and oxidative stress. Reata is developing bardoxolone methyl, its lead product candidate, as the first disease-modifying treatment for chronic kidney disease. In January 2010, Reata and Kyowa Hakko Kirin announced a licensing agreement providing KHK with the exclusive rights to develop and commercialize bardoxolone in Japan and other selected Asian markets.
For more information please visit the company's Web site at www.reatapharma.com.
About Abbott Laboratories
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.
Abbott Forward Looking Statement
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. Abbott cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, technological and other factors that may affect Abbott's operations are discussed in Item 1A, "Risk Factors," to our Annual Report on Securities and Exchange Commission Form 10-K for the year ended Dec. 31, 2009, and in Item 1A, "Risk Factors," to our Quarterly Report on Securities and Exchange Commission Form 10-Q for the period ended March 31, 2010, and are incorporated by reference. Abbott undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments.
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