KaloBios: KB003 Fails To Meet Primary Goal In Phase 2 Asthma Study

(RTTNews) - KaloBios Pharmaceuticals, Inc. (KBIO) Wednesday said its Phase 2 study of KB003, its anti-GM-CSF monoclonal antibody, in patients with severe asthma did not meet its primary clinical endpoint. The company decided to discontinue clinical development of KB003 in severe asthma. The stock plunged over 29 percent in the extended trade.

The randomized, double-blind placebo-controlled study showed that KB003 was generally safe and well tolerated, but it did not meet its primary clinical endpoint of improvement in FEV, a measurement of pulmonary function, compared to placebo in the overall study population.

The company also evaluated improvement in FEV compared to placebo in a number of pre-specified subgroup analyses. Of those subgroups, eosinophilic patients and patients demonstrating high reversibility at baseline showed a statistically significant improvement compared to placebo.

Other subgroups like atopic or non-atopic patients did not demonstrate a statistically significant improvement in FEV from baseline as compared to placebo.

In the key secondary endpoints, there was no meaningful reduction in exacerbations observed in patients receiving KB003 in the overall study population or in any material subgroup as compared to placebo.

There was no statistically significant improvement in asthma control questionnaire scores in the overall patient population.

David Pritchard, KaloBios' CEO, said, "Based on the initial data evaluation of this Phase 2 study, we are discontinuing clinical development of KB003 in severe asthma.''

Instead the company will refocus its resources on advancing other products in the clinic, especially KB001-A and its oncology program KB004. In KB001-A, the company continues to enroll patients in the Phase 2 study evaluating treatment of cystic fibrosis patients with Pseudomonas aeruginosa lung infections.

KBIO closed at $4.65 on Wednesday, down 0.15 percent from the previous close, and declined 29.25 percent in after-market trading.