KaloBios tanks as it halts KB003 development for asthma

31 January 2014

USA-based KaloBios Pharmaceuticals (Nasdaq: KBIO) revealed disappointing top line results from a Phase II study on KB003 in patients suffering from severe asthma , which failed to meet the key endpoints. The firm’s shares plunged as much as 50% on the news.

The Phase II randomized, double-blind placebo-controlled study failed to meet its primary objective of improvement in FEV1 (a measurement of pulmonary function) in comparison to placebo. KaloBios has decided not to develop KB003 further for the treatment of severe asthma.

KB003 also failed to demonstrate meaningful reduction in exacerbations in the overall study population or in any material subgroup compared to placebo. No significant improvements in questionnaire scores related to asthma control were observed during the study in the overall patient population. KB003 was however generally safe and well tolerated during the study, which was eventually over shadowed by the failure to meet key endpoints.

Pipeline needs to deliver says Zacks analysts

Analysts at Zacks Equity Research commented: “We are highly disappointed by the news on KB003. KaloBios does not have any marketed product. Consequently its pipeline has to deliver. Similar pipeline related setbacks will be catastrophic for the company.”

Following the decision not to develop KB003 further for the severe asthma indication, KaloBios now intends to concentrate on the two other candidates in its pipeline, KB001-A and KB004.

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