SOUTH SAN FRANCISCO, Calif.
Sept. 18, 2013
/PRNewswire/ -- KaloBios Pharmaceuticals, Inc. (Nasdaq:KBIO) today announced the publication of Phase 1 study results for KB001, a first generation, anti-
) type III secretion system (TTSS) antibody, for use in patients with cystic fibrosis (CF). Data from this initial single dose clinical study supports the continuation of KaloBios' ongoing Phase 2 study of KB001-A, a second generation, anti-TTSS antibody in CF patients with chronic
The Phase 1 study results appear online in the journal
, authored by
, M.D., of the Center for Excellence in Pulmonary Biology,
, and other members of the KB001 Study Group.
"Many patients with CF are chronically infected with
which contributes to disease progression by causing a strong inflammatory response that destroys lung tissue," said
Nestor A. Molfino
, M.D., M.Sc, KaloBios Chief Medical Officer. "Treating
infection with antibiotics has long been shown to benefit CF patients; however,
is not eradicated by such treatments and antibiotic-resistant strains soon emerge. KB001-A is a novel, non-antibiotic agent against
that targets and inhibits the bacterium's TTSS that is responsible for
's virulence and pro-inflammatory effects.
"The safety, pharmacokinetic and pharmacodynamic results obtained for KB001 in this initial single-dose Phase 1 clinical study supports the continuation of the Phase 2 study currently underway of KB001-A as a potential non-antibiotic treatment to reduce airway inflammation and tissue damage in CF patients with chronic
infection," Dr. Molfino concluded.
The published study results showed a single intravenous dose of KB001 to have an acceptable safety profile and a trend toward a short-term reduction in markers of inflammation, particularly neutrophil elastase which has long been recognized as the main enzyme responsible for lung damage in CF patients. The investigators concluded that repeat-dosing studies are required to evaluate the durability of the anti-inflammatory effects and how treatment with KB001 might translate into clinical benefit.