convenient arrangement for patients, Connelly says. “With a nebulizer, you have to breathe the drug in for 10 to 15 minutes. It’s not hard, it’s just time-consuming,” he says. “It’s not portable. You can’t be in an airport and nebulize.” PUR118, by contrast “is something you can put in your pocket and take with one or two puffs.”
Pulmatrix expects to start trials of PUR118 in patients with cystic fibrosis next year. It has already begun two Phase 1b studies in COPD. If all goes well, Connelly says, the drug could hit the market in the second half of 2017.
By raising more venture capital now, Pulmatrix can continue to develop the lung product on its own, without relying on a partnership with a Big Pharma company, Connelly says. He believes the company has enough resources to take PUR118 all the way through the FDA approval process, and to the marketplace in cystic fibrosis, a progressive, and fatal, condition that affects about 30,000 people in the U.S. The COPD market, estimated to be worth more than $9 billion, is already saturated with anti-inflammatory treatments such as GlaxoSmithKline’s fluticasone and salmeterol (Advair) as well as Pfizer and Boehringer Ingelheim’s tiotropium (Spiriva). Even though those drugs aren’t designed to work in the same way as Pulmatrix’s, running clinical trials and ultimately marketing any product in a market like COPD, which has millions of potential patients, “is an expensive and long path,” Connelly says. “We will look for a partner at some point.”
The dry powder approach has been so promising in early studies that Pulmatrix is already looking at applying it for other uses, Connelly says. For example, the company might consider taking existing oral or injectable drugs that have already gone generic and turning them into aerosol forms, he says. The company has tried reformulating certain drugs, such as antibiotics, and has conducted some studies in animals. “One thing that came out of the conversion to dry powder was we created an efficient platform for delivering drugs to the lungs,” Connelly says. “That may give us the opportunity to create first-in-lung products.”
