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Pulmatrix Names Clarke CEO, Releases Promising Data on Lung Drug

Xconomy Boston — 

Lexington, MA-based Pulmatrix, which is developing inhalable therapies for a variety of lung disorders, said today it is promoting chief scientific officer Robert Clarke to CEO. He will be replacing former CEO Robert Connelly, who is leaving Pulmatrix to become CEO of Cambridge, MA-based startup WikiCell, which he co-founded. Connelly will remain on the board of Pulmatrix.

Pulmatrix also released data from an early human trial of its lead compound, PUR118, in patients with chronic obstructive pulmonary disease (COPD). The data, which was presented at the European Respiratory Society Annual Congress in Vienna, showed that patients taking the drug experienced an improvement in airway inflammation and mucus clearance, the company said.

Pulmatrix, which was born in the labs of MIT’s Robert Langer (one of our Xconomists) and Harvard University’s David Edwards, has developed aerosol drugs designed to stimulate immune defenses and mobilize proteins to create barriers against pathogens. Pulmatrix is deploying the technology, called iCALM, to develop new therapies not only for COPD, but also other lung diseases such as asthma and influenza.

In the COPD trial Pulmatrix measured “biomarkers”—key signaling molecules in the body—of inflammation and found that PUR118 produced a measurable reduction in those markers. The company also observed an improvement in airway clearance. The results were similar to what was observed in animal tests, the company says. “In only three doses we saw a signal,” Clarke (pictured) says. “That’s incredibly encouraging.” The company is currently planning a mid-stage trial in COPD.

Pulmatrix is also testing PUR118 in cystic fibrosis and expects to release data from early trials by the second quarter of next year, Clarke says. At that point, the company will make a decision about which program to prioritize.

In some ways, cystic fibrosis is a more attractive opportunity than COPD, Clarke says. “It is a great unmet need,” he says. “We believe we would potentially be able to move faster in cystic fibrosis. The size of the next trials would not be as large as they would be for COPD.” Pulmatrix is actively seeking development partners to help move the compound forward in COPD, he says.

Pulmatrix has raised $60 million from a consortium of investors, including Polaris Venture Partners, 5AM Ventures, Arch Venture Partners, and Novartis Venture Fund. Clarke says he anticipates the company will go on the hunt for more funding within six months.

Pulmatrix will be looking for funding to support the further development of iSPERSE, a dry-powder technology that’s designed to enhance the delivery of its inhalable drugs. PUR118 is the lead product candidate created from the iSPERSE delivery platform. “As iSPERSE has emerged, we’re looking to raise additional funding to bring that commensurate with the iCALM development.”

Clarke brings a wealth of experience developing inhaled therapeutics to his new role as CEO. He joined Pulmatrix in 2004 as the first Ph.D.-level scientist and led the development of iCALM and iSPERSE. Prior to joining the startup, he was the associate director of life sciences at Alkermes, a developer of inhalable drugs that has a large presence in Waltham, MA. “As a pulmonary physiologist by training, I understand the biology of pulmonary disease, and as an engineer I’ve worked at length on these inhaled platforms,” Clarke says. “I have both perspectives, which gives me the ability to have a sound handle on the technical side while we move forward on our financing and partnership opportunities.”