KaloBios announced that the FDA has granted KB001-A Orphan Drug designation for the treatment of cystic fibrosis (CF) patients with Pseudomonas aeruginosa. KB001-A is a anti-PcrV monoclonal antibody (mAB) fragment.

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KaloBios is currently enrolling patients in a Phase 2 multiple-dose, randomized, double-blind, placebo-controlled clinical trial with KB001-A in CF patients chronically infected with Pseudomonas aeruginosa. This 180-patient study is intended to evaluate the efficacy and safety of repeat doses of KB001-A. The primary endpoint is time-to-need for antibiotic treatment for worsening respiratory tract signs and symptoms. The time-to-need for antibiotics will be the length of time between study dosing and administration of antibiotic as needed for worsening respiratory conditions.

For more information visit KaloBios.com.