Abbott Labs (ABT) and partner Reata Pharmaceuticals recently announced positive data on their chronic kidney disease candidate, bardoxolone methyl, at the American Society of Nephrology. Results from a phase IIb study indicated that treatment with bardoxolone methyl could result in a reduction in the severity of the disease and an improvement in the estimated glomerular filtration rate (eGFR) and other measures of kidney function.
Results showed that about 60% of chronic kidney disease patients being treated with bardoxolone methyl for 24 weeks experienced a reduction in the severity of their disease as compared to 17% of patients in the placebo arm. Moreover, Abbott Labs reported that only 4% of patients in the bardoxolone methyl arm experienced a worsening of the disease compared to 13% in the placebo arm.
The multi-center, randomized, double-blind clinical study was conducted with 227 chronic kidney disease patients with type II diabetes. Patients were randomized to receive once-daily doses of placebo or 25, 75 or 150 mg doses of bardoxolone methyl.
Phase III Could Commence in 2011
Abbot Labs and Reata are looking to move the candidate into a phase III study in the first half of 2011. Results from two previous phase II studies also showed that treatment with bardoxolone resulted in a significant improvement in kidney function in patients suffering from advanced chronic kidney disease and type II diabetes.
Immense Potential in Chronic Kidney Disease Market
The chronic kidney disease market represents significant commercial potential with more than 50 million adults affected worldwide. Moreover, the number of patients suffering from chronic kidney disease continues to increase.
Abbott Labs already has a presence in the renal care market — Zemplar is approved for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease and stage 5 treatment. Other treatments currently available for chronic kidney disease include Genzyme’s (GENZ) Renvela/Renagel and Shire’s (SHPGY) Fosrenol.
Neutral on Abbott Labs
We currently have a Neutral recommendation on Abbott Labs, which is supported by a Zacks #3 Rank (short-term “Hold” rating). Despite facing challenges like the impact of US healthcare reform, product recalls, foreign exchange headwinds and EU pricing austerity, Abbott Labs’ strong business segments, contributions from recent acquisitions and impressive late-stage pipeline should help the company deliver strong earnings growth.
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