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out in the direction of other people. Essentially, it should make flu a whole lot less contagious.
Sounds great, but where’s the proof? Pulmatrix hasn’t said a whole lot publicly on this point. It issued a press release on May 1 saying that it completed a Phase I clinical trial that assessed the safety and tolerability of single escalating doses of its first drug, PUR003, in eight patients. The drug was found to be well-tolerated, with no severe adverse events reported. Animal studies, presented at a National Institutes of Health antiviral workshop, have shown that in multiple species, and with multiple strains of flu viruses, the drug worked. That included swine flu. Because of the way the drug is designed to work, it is thought to be able to both treat and prevent flu infections.
Based on the animal tests, and the early safety trial in humans, Pulmatrix is moving into a tougher test, a study in which 25 healthy volunteers will be randomly assigned to get its drug or a placebo, and see how they do after they’ve been exposed to the flu in a controlled environment.
This study is expected to get started next month, and assuming no snags or enrollment delays, it should produce results as soon as October, Connelly says.
The study, while small, will produce a lot of evidence that people at the Centers for Disease Control and Prevention, the National Institutes of Health, and the higher reaches of the U.S. Deparment of Health and Human Services will want to see. People in those government agencies have been meeting with Pulmatrix to talk about its technology, and they weren’t just picking up the phone and hopping on the bandwagon after the “swine flu” headlines hit, Connelly says.
The company’s technology is obviously at very early stages. The Phase I study in eight patients was done in a liquid formulation that’s delivered via a nebulizer—a clunky contraption that patients need to inhale from for a few minutes, twice a day. These devices are currently used for patients with cystic fibrosis, a fatal lung disease that causes buildup of thick, sticky mucus in the lungs, but it’s probably not the most practical way to deliver a mass-marketed flu drug, Connelly says. So Pulmatrix is working on two main delivery technologies.
One is a liquid nebulizer form for severe lung diseases like cystic fibrosis and chronic obstructive pulmonary disease, in which a nebulizer isn’t too much of an inconvenience. The other is a dry powder form that could be made into a portable inhaler like the ones people carry around for asthma attacks. That more convenient package is expected to enter clinical trials in the first half of 2010, Connelly says.
“You could take one or two puffs in the morning before work,” Connelly says. For a market like flu, which is episodic rather than chronic, “two minutes on a nebulizer would be too inconvenient,” he says.
The list of potential applications is a long one, with asthma, allergies, and rhinovirus (common cold) also ranking as high priorities, Connelly says. All of the trials to prove these concepts would take money, of course. Unlike most entrepreneurs I’ve been talking to, this didn’t seem to worry him much. The company has grown from 14 employees in January 2008 to about 34 now, and it expects to continue to grow. Pulmatrix secured an additional $3 million from Polaris and 5AM Ventures in March, and the company expects to do a Series B financing later this year. “We’re in good shape now,” Connelly says. “The good news for us is our existing investors are passionate about the company.”
And the competition? That’s mostly from established players like Roche’s oseltamivir (Tamiflu) and GlaxoSmithKline’s zanamivir (Relenza), although neither one is designed to modify the mucus lining of the lungs or offer such broad potential as Pulmatrix. “We’re really very much unique in the approach we’re taking,” Connelly says.
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