KaloBios Pharmaceuticals, Inc. (KBIO) announced that one of its principal candidates, KB001-A, has failed to meet the primary endpoint in a randomized, double-blind, placebo-controlled phase II study. The company was developing KB001-A for the treatment of Pseudomonas aeruginosa (Pa) lung infections in patients suffering from cystic fibrosis. KaloBios Pharma’s shares fell significantly in the pre-market trading session following the announcement.
In the study, which evaluated KB001-A versus placebo, the candidate failed to demonstrate an increase in the time to need for antibiotics for worsening respiratory tract signs and symptoms, which showed that KB001-A could not reduce the risk of developing pulmonary exacerbations. Additionally, KB001-A did not show any improvement compared to placebo, in the time to need for antibiotics, in few other pre-specified subgroup analyses conducted by the company.
Nevertheless, top-line data showed that KB001-A was generally safe and well tolerated. KB001-A-treated patients demonstrated an insignificant reduction in Pa titer in sputum when measured after dosing along with a meager 3% improvement in FEV1 (secondary endpoint) at week 16 compared to placebo. The company said that these results were not supported by improvement in other clinically significant endpoints.
Based on this data, KaloBios Pharma has discontinued the development of KB001-A in cystic fibrosis. The company intends to focus on its oncology pipeline going forward, particularly on KB004. Currently, it is enrolling patients in the phase II expansion portion of a phase I/II study evaluating KB004 in patients suffering from myelofibrosis, myelodysplastic syndrome and acute myeloid leukemia. KaloBios Pharma also intends to study KB004 for additional oncology indications including solid tumors and other hematologic malignancies.
KaloBios Pharma said that it will continue to look for a partner for the advancement of the KB001-A program.
KaloBios Pharma carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the healthcare sector are Progenics Pharmaceuticals, Inc. (PGNX), Actavis plc (ACT) and Supernus Pharmaceuticals, Inc. (SUPN). While Progenics carries a Zacks Rank #1 (Strong Buy), Actavis and Supernus hold a Zacks Rank #2.
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