KaloBios Pharmaceuticals, Inc. Discontinues Lung Infection Drug, Stock Sinks
January 7, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff
KaloBios Pharmaceuticals, Inc. yesterday announced that its Phase II study of the antibody KB001-A used to treat Pseudomonas aeruginosa (Pa) lung infections in subjects with cystic fibrosis (CF) failed to meet its primary endpoint. The company has decided to discontinue the development of the drug.
KaloBios made the announcement yesterday, after the market had closed. In after hours trading, the price plunged more than 61 percent, and is down 68 percent in mid-morning trading.
The Phase II clinical study was a randomized, double-blind, placebo controlled study in which 182 subjects were given either KB001-A or a placebo. The participants were CF subjects with Pa lung infections. The endpoint was to achieve an “increased time to need” for antibiotics for worsening symptoms, which signals a reduction of the risk to develop pulmonary “exacerbations,” or flare-ups.
During the 16-week trial, 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. No subgroup demonstrated an improvement with KB001-A versus placebo.
“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 Chief Executive Officer of KaloBios David Pritchard. “Based on these top line data, we intend to discontinue our development of KB001-A in cystic fibrosis."
From 2010 until July 2014, KaloBios had been in partnership with Sanofi Pasteur to develop the KB001-A program. When KaloBios announced the dissolution of the partnership in July 2014, which saw the company regain exclusive rights to the development of the KB001-A program from Sanofi, KaloBios did not indicate a reason for the split.
At the time of the July announcement, BioSpace reported that, “earlier phase 1/2 studies conducted by Kalobios and Sanofi demonstrated a 50 percent reduction in lung infections with KB001-A,” which had been granted Fast Track Status by the U.S. Food and Drug Administration (FDA).
KB001-A is the second drug in KaloBios’ pipeline to fail its clinical trials in the past year. In January 2014, KaloBios announced its drug KB003 failed to meet its primary endpoint of meaningful improvement in pulmonary function in patients with severe asthma during a Phase II trial. The company decided to stop developing that drug, as well. KaloBios will now “focus resources and efforts on advancing our oncology programs,” Pritchard said in today’s statement.
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