KB003: Development discontinued

KaloBios discontinued development of KB003 to treat severe asthma after top-line data from a double-blind, international Phase II trial in 160 patients with severe asthma inadequately controlled on corticosteroids showed that 400 mg IV KB003 every 4 weeks missed the primary endpoint of improving mean FEV1 from baseline to week 24 vs. placebo. The company said the trial was powered at 80% to detect a 6.7% improvement in FEV1 when compared to placebo. KB003 was generally well tolerated. KB003 did significantly improve FEV1 vs. placebo in pre-specified subgroups of patients with baseline blood eosinophil levels of >=300 cells/mL and in patients who could achieve a >20% improvement in FEV1 when treated with a bronchodilator at baseline. KB003 also missed the secondary endpoints of reducing asthma exacerbations and improving ACQ scores vs. placebo. All patients received standard of care (SOC) consisting of long-acting adrenergic receptor beta 2 agonists (LABAs) and inhaled glucocorticosteroids. Patients enrolled in the trial were required to be able to achieve a >=12% improvement in FEV1 when treated with a bronchodilator at the time of enrollment. The company said it will continue to analyze the data to determine next steps, if any, for KB003. ...