in its early days that prompted this round of investment interest. The company identified 62 different bacterial invaders that are considered “worst of the worst” and determined that its antibiotic combo can kill them at “reasonable” concentrations in the petri dish, Montgomery said, noting that data on this study was presented this week at the American Thoracic Society meeting in Philadelphia.
Second, the company showed that its nebulizer, developed with help from Germany-based Pari, was able to deliver concentrations into the lungs that are 50 times higher than necessary to kill the bugs. The nebulizer takes about 12 minutes to deliver the drug to a patient on a hospital ventilator, Montgomery says. (You can search on “author” and “Montgomery” here on the ATS website for the full results).
That data, Montgomery’s track record, and the knowledge that hospitals are becoming more motivated to fight ventilator-associated pneumonias, helped the company raise this new round of cash, says Thong Le, a managing director with WRF Capital.
The new money will be used to help Cardeas test its concept in a much more rigorous way. The company is seeking FDA clearance to start a mid-stage clinical trial in July that will enroll about 150 evaluable patients, Montgomery says. The study will give all patients the best available IV antibiotics, and randomly assign them to get the Cardeas drug on top of that, or a placebo. The main goal will be to show that the Cardeas drug is superior to existing antibiotics on a respiratory disease severity score, and the study will also collect data on secondary measurements such as, time spent on the ventilator, time spent in intensive care, length of hospital stay, and death rate. By designing the test to demonstrate superiority, Montgomery is hoping to motivate doctors to enroll patients in the study, and to eventually prove that the brand-name drug can someday justify a far higher price than today’s generics.
Cardeas isn’t the only company, of course, thinking of ways to fight pneumonia in hospitals. Bayer has a competing aerosol antibiotic in the works for ventilator-associated pneumonia, but no one has yet won FDA approval for such a treatment, Montgomery says.
Part of the reason no one has come along yet in the field is that “most antibiotic companies don’t understand aerosols, and there hasn’t been a good delivery system,” Montgomery says. Often, the particles are so big that they get stuck in the breathing tube, and don’t get deep in the lung. Cardeas is using is a modified form of the Pari e-Flow device that he and his team used before to develop aztreonam lysine (Cayston) to fight lung infections in cystic fibrosis patients. “We had to develop a good delivery system, and that’s a big breakthrough,” Montgomery says.
Cardeas expects to have results from this study, which follows patients during a 28-day observation period, about 15 months after the trial gets underway this fall, Montgomery says. If the company passes that study, showing that its drug is superior to existing antibiotics in patients, then the company will clearly be worth much more, and be able to raise more money on favorable terms for the final stretch run of clinical trials needed for FDA approval.
The company is so confident that it will be in a good position two years from now, Montgomery says, that he turned away an additional $50 million worth of investment at today’s terms. “All we need to do is get to next milestone, and we’ll have another value inflection point,” Montgomery says.
Cardeas currently only has nine employees, and doesn’t plan to do much hiring with the new money, leaning instead on a network of contract research organizations to handle much of the trial work, Montgomery says. He’s not going to move into fancy new offices, he says.
“The cholesterol score on this company is about 20. We’re lean,” Montgomery quips. “Nowadays you can outsource things you couldn’t do 10 years ago.”
