in clinical trials to prove this notion. One study presented in May looked at 35 patients in France who were getting antibiotics while on mechanical ventilators in the hospital. About 46 percent of the patients on a single high-dose IV infusion of the KaloBios drug were alive and pneumonia-free after 28 days, compared with 20 percent who did that well on a placebo. Another trial of 27 patients with cystic fibrosis showed that the drug looked safe, and was able to reduce the amount of inflammation and pneumonia bacteria in patients. Both studies were presented to doctors at the American Thoracic Society annual meeting in May.
While the intravenous form of the drug might be fine for patients who get pseudomonas infections in the hospital intensive care unit, KaloBios needs to reformulate the drug for more chronic usage if it wants to treat cystic fibrosis patients. That’s happening now, as the company is developing a form that patients can self-inject just under the skin once every two weeks. That new form of the drug should be ready for clinical trials in late 2011, Pritchard says.
KaloBios will have to do better than that in the next round of clinical trials, showing it can help people breathe better over a 28-day period, if it wants to win FDA approval for the new drug. But if it can clear that hurdle, it could have quite a valuable new asset. Cambridge, MA-based Vertex Pharmaceuticals has a couple of novel small-molecule drugs in the pipeline for cystic fibrosis patients that have been hailed by leading researchers, but nobody else has an antibody drug in clinical trials, Pritchard says.
If this drug can get through the clinical trial process, it will have the advantage of 12-year market exclusivity for biotech drugs that was part of the recently passed healthcare reform. The KaloBios drug would certainly be a high-priced product. The antibiotics on the market now have helped cystic fibrosis patients extend their average lifespan into their late 30s, and it’s conceivable that KaloBios could extend that number further if it can kill pseudomonas and solve the problem with antibiotic resistance. Do that, and perceptions might change about antibodies being useful for more than just cancer and autoimmune disease.
“Antibodies are what your body produces to fight infections. So we’re making antibodies for infectious disease. It makes perfect sense,” Pritchard says.
