Pulmatrix, the Lexington, MA-based company with an unusual strategy for fighting diseases of the lungs, is announcing today that it has secured $14 million in a Series B1 venture round, bringing the total amount raised by the company to $60 million. All of Pulmatrix’s existing investors participated, including Polaris Venture Partners, 5AM Ventures, Arch Venture Partners, and Novartis Venture Fund.
The company also announced that it will advance its lead compound, called PUR118, as a new treatment for cystic fibrosis, and chronic obstructive pulmonary disease (COPD)—an umbrella term for diseases like emphysema and chronic bronchitis that commonly affect smokers. Recently completed Phase 1 studies in healthy volunteers showed the new drug was safe and well-tolerated, the company reports, so Pulmatrix will move the treatment into additional trials designed to measure PUR118’s effects on airway inflammation and mucus. The new cash, says CEO Robert Connelly, “will get us through these critical studies over the next 18 months, which will put us in position to plan larger, pivotal studies.”
Pulmatrix is using its technology platform, which it calls iCalm, to create aerosol treatments that attack lung ailments from three directions. First, they have positively-charged ion-based compounds, like calcium and magnesium, which stimulate the immune system to fight off many different pathogens that people breathe in all the time, like viruses and bacteria. “We have the ability to take on all comers—we can deal with any airborne infection, ” Connelly says. Secondly, the drugs produce an anti-inflammatory effect without the use of steroids-a common ingredient in many lung remedies. And finally, they help clear mucus from the lungs.
PUR118 is a dry powder that patients can inhale. Pulmatrix initially developed it as a liquid formulation, called PUR003, which patients had to inhale via a somewhat bulky machine called a nebulizer. Pulmatrix reformulated the drug so it could be used like an asthma inhaler—a far moreconvenient 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.”
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