KaloBios Pharmaceuticals, Inc.
) announced disappointing top line results from a phase II study
on KB003 in patients suffering from severe asthma, where the
candidate failed to meet the key endpoints. We expect the news to
have a significant adverse impact on the shares.
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
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. The
company is currently enrolling patients for a phase II study on
KB001-A for the treatment of cystic fibrosis patients suffering
from pseudomonas aeruginosa (Pa) lung infections. KaloBios is
evaluating KB004 in a phase II expansion study for the treatment
of patients suffering from acute myeloid leukemia and
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.
KaloBios carries a Zacks Rank #3 (Hold). Some better-ranked
). All these stocks carry a Zacks Rank #1 (Strong Buy).
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