Stromedix: Fibrosis is ready for prime time
Where business angels fear to tread, Stromedix is rapidly expanding its footprint.
With its lead compound entering a Phase II clinical trial for idiopathic pulmonary fibrosis (IPF), the company announced it had licensed a second integrin compound for acute and chronic organ failure.
“We are very committed to fibrosis, a hugely important, unmet medical need that is ready for prime time,” said Stromedix CEO Michael Gilman. “The time is right now to move to the clinic.”
At BIO-Europe Spring® in Milan, Gilman said he is meeting with companies who recognize fibrosis not as a disease but as a pathology.
“Our dream date is someone who understands this potential for leverage across multiple major diseases,” he said.
“Several large biotech and pharma companies have identified fibrosis as a therapeutic interest,” he said, adding, “our timing is good.”
In the five years since founding the company, Gilman has patiently built a small virtual development team in Cambridge, Massachusetts to advance an asset that had been shelved by Biogen Idec.
This year the humanized monoclonal antibody (mAb) to integrin alpha-V beta-6 called STX-100 will begin a Phase II trial indicated for IPF.
On the heels of this success, Gilman quickly announced that Stromedix had acquired a second antibody, to integrin alpha-V beta-5.
“We’ve made significant progress in tackling the challenges of clinical development in fibrotic diseases. With this new program, we can take advantage of what we’ve learned to expand our footprint in fibrosis,” he said.
Meanwhile, Gilman said the Stromedix team “is jazzed about the IPF trial.”
“Beyond the unique mechanism of action of STX-100, what we are excited about is the design of the clinical trial,” he said, explaining that the development team created a novel biomarker strategy for following the drug action on alveoli, or air sacs, in the lung.
“The technical problem we faced is really a business problem that asks how we can measure anything meaningful in a short-term clinical trial for a long-term fibrotic disease,” he said.
“In other words, how we can get an answer as to whether the drug is working with USD 20 million instead of USD 200 million,” said Gilman.
In the Phase II trial, the Stromedix strategy uses bronchoalveolar lavage to flush out cells to be analyzed to determine if the mechanism is working.
Inspiring confidence with investors
At BIO-Europe Spring, Gilman will lead a panel discussion, “Financing Innovation: A Conversation With US and European VCs Who Still Invest Early.”
The former head of research at Biogen Idec, Gilman is a standout among start-up CEOs, inspiring investor confidence with high science in a space where few have found the courage to advance.
Peter Barrett, who represents Atlas Venture, said he believes Stromedix will be a leader in fibrosis, a field “with multibillion dollar market potential that has no existing approved products and very few products in clinical development.”
Atlas Venture was the first to back Gilman and as the business idea and company took shape, it joined a consortium of investors that today includes New Leaf Venture Partners, Bessemer Venture Partners, Frazier Healthcare Ventures, Red Abbey Venture Partners and Biogen Idec.
Stromedix has raised USD 29.4 million to date in two venture rounds, and in January 2011, drew a further USD 2 million in a debt financing that may extend to USD 15.5 million.
On leaving Biogen Idec in 2005, the former Head of Research said he was able to convert what he called “soft stuff” into a hard asset.
“In a sense I reversed the normal process in early investing where someone typically has an asset and goes around asking for money,” he said. “Instead, I lined up the money first and then went looking for the asset.”
A memorable brainstorming session with Atlas Venture soon after his departure from Biogen ended with a rough idea to build a business focused on fibrosis.
“The analysis was not deeper than that,” said Gilman. “Atlas gave me an office to figure it out and it took me almost a year and a half to create the proposal,” he said.
Winning additional backing from Frazier Healthcare, Gilman said his research for a candidate drug to develop for fibrosis led him back to Biogen.
“When I left Biogen the alpha-V beta-6 integrin was being actively developed, but I later learned Biogen shelved the program as part of its annual portfolio review,” he said.
“The advantage I had was knowing it was there and that it was worth having,” he said.
“Then, I knew what buttons to push to get it out, because big companies are usually not interested in out-licensing, and there is not a template for doing that,” he said.
Stromedix negotiated a license with Biogen in May, 2007 for the mAb that became STX-100.
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