KaloBios Pharmaceuticals, Inc. today announced that dosing has begun in
a randomized, double-blind, placebo-controlled Phase 2 clinical trial of
KB003, the company's anti-GM-CSF Humaneered monoclonal antibody, in
subjects with severe asthma uncontrolled by corticosteroids.
The multi-center study will enroll approximately 150 subjects at sites
throughout the United States, Europe and Australia. Subjects will be
dosed with KB003 or placebo in addition to current therapy for 5 months.
The primary endpoint for the study is the change in mean
pre-bronchodilator forced expiratory volume (FEV1) from
baseline, a marker of airway obstruction. Secondary endpoints include
asthma exacerbation rate and the degree of asthma symptom control.
KaloBios expects to complete the study in Q1 2014.
"KB003 is a potent inhibitor of GM-CSF, a cytokine thought to be central
to the inflammatory response that activates immune cells believed to
play a key role in the two main phenotypes of asthma, allergic and
non-allergic," said Néstor A. Molfino, M.D., KaloBios' Chief Medical
Officer. "Results of a previous Phase 1/2 study showed this antibody to
be well tolerated and non-immunogenic. We now look forward to evaluating
the therapeutic potential of KB003 in a severe asthma patient population
in a randomized, placebo-controlled trial with repeat dosing."
"This clinical study is an example of our strategy of enriching patient
selection for response to our therapeutic agents (patient targeted
antibody therapy)," said David Pritchard, KaloBios' Chief Executive
Officer. "We hope to expand upon the activity of our anti-GM-CSF
antibody seen in our previous clinical study."
"We are targeting the severe asthma population which represents
approximately 5 - 10% of the total asthma population of more than 300
million people. Severe asthma is responsible for approximately 50% of
asthma hospitalization costs," noted Mr. Pritchard.
Long-term PM2.5 exposure increases asthma risk