KaloBios Plunges As KB001-A Fails To Meet Primary End Points In CF Patients

(RTTNews) - Shares of KaloBios Pharmaceuticals Inc (KBIO) slid 62 percent in extended-hours trade on Tuesday after it said that a Phase 2 study of KB001-A, an anti-PcrV monoclonal antibody fragment, to treat Pseudomonas aeruginosa lung infections in subjects with cystic fibrosis failed to meet its primary end point.

In a statement, the company said that while the data from the study showed KB001-A was generally safe and well-tolerated, the primary endpoint of increased time to need for antibiotics for worsening respiratory tract signs and symptoms (an indicator of reduction of the risk to develop pulmonary exacerbations) was not met.

The company also evaluated time to need for antibiotics in a number of pre-specified subgroup analyses known to be associated with such risk and none demonstrated an improvement for KB001-A versus placebo.

KaloBios said that based on the top line data, it plans to halt development of KB001-A in cystic fibrosis, and that it would focus resources and efforts on advancing its oncology programs.

The Phase 2 study of KB001-A in cystic fibrosis subjects with Pa lung infections was a randomized, double-blind, placebo controlled study in which 182 subjects were randomized one to one between treatment with KB001-A or placebo.

KBIO closed Tuesday at $1.83, down $0.02 or 1.08%, on a volume of 1.6 million shares on the Nasdaq. In after hours, the stock plunged $1.13 or 61.75%.