Emerging Drug Developer: Pulmatrix

Pulmatrix aims for game-changing respiratory drugs

The 33 staffers at Pulmatrix are headed straight to one of the crossroads that helps define an emerging company's prospects in the biotech world. Its lead respiratory disease therapy is wrapping a Phase Ia/IIb clinical trial and there are ambitious plans to launch a series of new clinical studies in 2010 and 2011.

And now it has the money in the bank to make those plans a reality.

In a Series B financing announced this morning, Arch Venture Partners and Novartis Bioventures Fund co-led a $30.2 million round that includes the developer's original backers: Polaris Venture Partners and 5AM Ventures. As a plus, the developer also announced today that it has received a $2.2M grant from the National Institute of Allergy and Infectious Diseases for its work on seasonal and pandemic influenza--the first of many such grants it expects to garner.

"We have one lead program in the clinic and two programs that we will push into the clinic next year," reports Lexington, MA-based Pulmatrix CEO Robert Connelly. The two new programs "are more potent and convenient formulations of what is in the clinic. So we'll have three different formulations available to move into Phase II studies."

Connelly has been here before. He was the founding CEO of Domantis, an aggressive antibody developer that was bought up by GlaxoSmithKline in 2006--after being selected as one of that year's Fierce 15--for $454 million. At Domantis he quickly ramped up a dozen different antibody programs. And he's brought the same entrepreneurial bent to his latest start-up.

"It's a standard challenge trial," says Connelly about the trial now underway, "with healthy volunteers treated and infected with a mild flu virus." The endpoints: "Is the drug well tolerated? And do we see a reduction in symptoms' duration and severity? We will follow that with a trial that starts in December, a challenge trial with asthmatics."

In that trial, patients allergic to specific allergens will be treated and challenged with the allergen. "The main endpoint is safety," says the CEO, with researchers looking for signs of a reduction in allergic reaction. "We should have results at the end of the first quarter."

The developer has an impressive group of scientific mentors.

One of the principal founders of the company is David Edwards, a Harvard professor who has specialized in the biomechanics of the lung. Edwards has been working with MIT's Alexander Klibanov and the ubiquitous Bob Langer, whose scientific endeavors have inspired a string of biotech start-ups.

Pulmatrix has set out to shake up the traditional approach to developing new therapies for infectious and progressive respiratory diseases. Forget the old single-pathogen approach--what Connelly calls the "one drug, one bug" strategy. By stimulating a variety of natural defense mechanisms in the body, Pulmatrix is betting that it can prevent a host of pathogens from penetrating lung tissue. And there are a variety of combination therapies that could be derived from this approach.

"We have generated some very impressive combination data with an influenza treatment," notes Connelly. "There's definite synergy in bringing multiple mechanisms to play."

Its timing couldn't be better. Pulmatrix is laying the groundwork for new trials at a time the world's first pandemic in 40 years is wreaking influenza havoc around the world. And the company believes it has the inside track on an "approach that appears pathogenic-strain agnostic."

Connelly wouldn't be surprised if he eventually finds himself in buyout talks once again.

"We could always get there (a buyout) eventually," says the CEO. "I think that's probably where this is going, and that's going to depend on the clinical data. Following these trials we'd like to see something in COPD and follow on with a larger trial, a treatment trial in influenza, getting additional formulations trialed in Phase II. From the perspective of building value, we'll feel that we've built a valuable entry. At a minimum we'll do some partnerships, or something larger."

Pulmatrix's work is also a central priority for government initiatives aimed at the flu. And Connelly is betting that there's some additional non-dilutive cash out there to help fund its work. And that shouldn't take too long to realize.

"I do think you we'll see next year additional non-dilutive funding from governments and foundations next year," says the CEO.

Emerging Drug Developer: Pulmatrix

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