KaloBios to Stop KB003 Development for Asthma - Analyst Blog
31 January 2014 - 10:50AM
Zacks
KaloBios Pharmaceuticals, Inc. (KBIO) 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 endpoints.
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 myelodysplastic
syndrome.
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 stocks
include Actelion Ltd. (ALIOF), Affymetrix
Inc. (AFFX) and Gentium (GENT). All these
stocks carry a Zacks Rank #1 (Strong Buy).
AFFYMETRIX INC (AFFX): Free Stock Analysis Report
ACTELION LTD (ALIOF): Get Free Report
GENTIUM SPA-ADR (GENT): Free Stock Analysis Report
KALOBIOS PHARMA (KBIO): Free Stock Analysis Report
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