KaloBios Pharmaceuticals announced
they plan to discontinue develop of their drug to treat lung infections in patients with cystic fibrosis following the disappointing results obtained in their phase II study. The randomized, double-blind, placebo-controlled Phase II study of KB001-A, an anti-PcrV monoclonal antibody (mAb) fragment, to treat Pseudomonas aeruginosa
) lung infections in subjects with cystic fibrosis showed the drug was generally safe and well-tolerated but 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. Subgroup analyses also did not meet the primary endpoint.
People with cystic fibrosis are at greater risk of bacterial lung infections due to the mucus build up. Lung infections remain a serious and chronic problem for many patients with cystic fibrosis.
David W. Pritchard, KaloBios' president and chief executive officer (CEO) said:
"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."
"Based on these top line data, we intend to discontinue our development of KB001-A in cystic fibrosis."
Two days after announcing the results of the phase II study, Mr Pritchard decided
to retire - effective immediately - as president and CEO of the company. The company's chief financial officer, Herb Cross, was named interim CEO pending a search for a new CEO.
KB001-A Trial Design
The Phase 2 clinical study of KB001-A in CF subjects with Pa
lung infections was a randomized, double-blind, placebo controlled study in which 182 subjects were randomized one to one between treatment with KB001-A or placebo. Eligible subjects were identified as CF patients whose lungs were colonized with Pa
at the time of entry into the study, and who had been compliant in taking their antibiotics for at least the preceding two cycles. Subjects enrolled in the 16 week study were allowed to continue on their antibiotics in the first four weeks of the study, after which antibiotics were withdrawn for the remainder of their time on the study. Throughout the 16 week study duration, subjects received either placebo or KB001-A dosed at 10 mg/kg every four weeks via intravenous administration with one additional loading dose at Week 2. The primary endpoint of the study was the time to need for antibiotics for respiratory signs and symptoms and was analytically expressed as a hazard ratio.
KaloBios Pharmaceuticals, Inc. is developing a portfolio of proprietary, patient-targeted, first-in-class monoclonal antibodies designed to treat severe life-threatening or debilitating diseases for which there is an unmet medical need, with a focus on cancer.
Cropped image courtesy wikimedia commons.