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news.KaloBios Pharmaceuticals, announced top-line data from the randomized, double-blind, placebo-controlled Phase II study of KB001-A, an anti-PcrV monoclonal antibody (mAb) fragment, to treat Pseudomonas aeruginosa (Pa) lung infections in subjects with cystic fibrosis (CF).
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While the data from this 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.
In addition, secondary endpoints such as improvements in FEV1 and subject-reported outcomes as measured by Cystic Fibrosis Respiratory Symptom Diary (CFRSD) did not show an advantage with KB001-A treatment.
"The study did demonstrate a non-significant reduction in Pa titer in sputum measured post dosing and a 3% improvement in FEV1 (p=0.0029) at Week 16 for the KB001-A arm compared to placebo; however, these effects were not accompanied by improvements in other clinically significant end-points such as exacerbations or symptoms," said Nestor A. Molfino, MD, MSc., KaloBios’ Chief Medical Officer.
"The KaloBios team is still collecting all of the patient data and working to further understand the results and plan to submit our comprehensive findings to a scientific meeting or journal."
"We are very disappointed that KB001-A did not demonstrate a clinically significant effect on Pa infections in these CF patients, but we are thankful to all of them for volunteering to participate in this study," said David W. Pritchard, KaloBios’ President and Chief Executive Officer. "Based on these top line data, we intend to discontinue our development of KB001-A in cystic fibrosis."
"Going forward, KaloBios will focus resources and efforts on advancing our oncology programs. Specifically, we are working to advance our KB004 oncology program as well as to expand the oncology development portfolio with the possible introduction of additional oncology indications for KB004 or for KB003, our anti-GM-CSF antibody.
Currently, the KB004 Phase 2 cohort expansion study evaluating subjects with myelofibrosis, myelodysplastic syndrome, and acute myeloid leukemia is actively enrolling," said Mr. Pritchard.