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the company’s risk, and helps establish credibility when it comes to forming collaborations with pharma.
“If there’s uncertainty in Phase I, it means we can’t go to Phase II,” Baltera says. “The data is what the data is. This is a pharmaceutical style small-molecule strategy. You pick the best one and go forward.”
While the Glaxo partnership provides essential cash to keep the lights on, Amira is trying to build its company around a very early-stage drug program for idiopathic pulmonary fibrosis. This is a fatal disease, and scientists don’t know what causes it. There aren’t any FDA-approved therapies at the moment. A couple of other companies, Brisbane, CA-based Intermune and Switzerland-based Actelion Pharmaceuticals, are further along with pulmonary fibrosis treatments, this is uncharted territory from a regulatory standpoint, meaning it’s hard to say exactly what the FDA will demand from a new therapy.
That sounds like the kind of risky bet that you’d expect from a biotech company. One of Amira’s scientific collaborators, Andrew Tager of Massachusetts General Hospital, has published data that suggests a drug which blocks a target called LPA1 might be useful for pulmonary fibrosis, and Amira has developed a drug, tested it in mice, and seen some promising results. Since this is a relatively uncommon disease, the clinical trials, and commercialization push could conceivably be handled by a small company like Amira, Baltera says. Amira has the incentive to do this since it has 100 percent of the commercial rights, Baltera notes.
This year will be a critical test for Amira’s strategy. It expects to have its lead candidate ready for its first clinical trial, by mid-to-late 2010, Baltera says. It will have a backup candidate right behind that. The first results from people should be available about a year later. If all goes well, then it can start taking a serious look at testing it for other fibrotic scarring conditions, like cirrhosis of the liver and certain kidney diseases. It might even be time by then to start whispering about an initial public offering, he says.
“It’s going to be all hands on deck around here in 2010,” Baltera says.