Abbott Labs (ABT) and partner Reata Pharmaceuticals, Inc. recently announced the presentation of new phase II data on bardoxolone methyl. In addition to being posted online in The New England Journal of Medicine, the data were also presented at the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Congress.
The phase II BEAM study was conducted in patients with moderate to severe chronic kidney disease and type II diabetes. Results showed that patients receiving bardoxolone methyl for 52 weeks experienced a sustained improvement in kidney function throughout the treatment period as measured by estimated glomerular filtration rate (eGFR), which is an important measure of kidney function.
All three doses (25, 75 or 150 mg) of bardoxolone methyl achieved a statistically significant improvement in eGFR compared to placebo. Moreover, only 9% of patients in the bardoxolone methyl arms experienced a loss in kidney function compared to 19% in the placebo arm over 52 weeks. The data indicate that bardoxolone methyl could delay the progression of kidney disease in patients with compromised kidney function.
Bardoxolone in Phase III Development
Abbott Labs and Reata recently commenced a pivotal phase III study with bardoxolone methyl. Bardoxolone methyl’s safety and efficacy will be evaluated in patients with chronic kidney disease and type II diabetes.
The multinational, double-blind, placebo-controlled phase III study, BEACON (Bardoxolone methyl EvAluation in patients with Chronic kidney disease and type 2 diabetes: the Occurrence of renal eveNts), will be conducted with about 1,600 patients across 300 sites. Patients will be randomized 1:1 to receive either a 20 mg reformulated version of bardoxolone methyl or placebo once daily.
While the primary efficacy endpoint is a time-to-first-event composite consisting of progression to end-stage renal disease (ESRD) and cardiovascular death, secondary endpoints include change in eGFR and a time-to-first-event composite consisting of hospitalization for congestive heart failure (CHF), non-fatal myocardial infarction (MI), non-fatal stroke and cardiovascular death. Results will be out in 2013.
Immense Potential in Chronic Kidney Disease Market
The chronic kidney disease market represents significant commercial potential with more than 26 million patients affected in the US. 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 in the renal care market include Sanofi-Aventis’(SNY) Renvela/Renagel and Shire’s (SHPGY) Fosrenol.
Neutral on Abbott Labs
We currently have a Neutral recommendation on Abbott Labs, which carries a Zacks #3 Rank (short-term Hold rating). Abbott Labs’ strong business segments and contributions from recent acquisitions should help fortify growth. While lead product, Humira, will continue to be a huge growth driver in the next couple of years, we remain concerned about Abbott Labs’ dependence on the product. Moreover, Abbott Labs’ pharma pipeline needs to deliver in order to drive long-term growth.
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