(ABT) Abbott Labs’ Bardoxolone in Phase III Trials

Abbott Labs (ABT) and partner Reata Pharmaceuticals, Inc. 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.

Study Design

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 estimated glomerular filtration rate (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.

Positive Phase II Data Presented in Nov 2010

In Nov 2010, AbbottLabs and Reata had presented positive phase II data on bardoxolone methyl at the American Society of Nephrology. Results from the 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.

Immense Potential in Chronic Kidney Disease Market

The chronic kidney disease market represents significant commercial potential with more than 26 million adults 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 is supported by 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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