When Cambridge, MA-based Stromedix raised $25 million in 2008, CEO Michael Gilman said he hoped to have the company's lead drug, STX-100, well into Phase II trials by mid-2010. The drug, which was licensed from Gilman's former employer Biogen Idec, treats interstitial fibrosis, which can cause transplanted kidneys to fail. But the FDA has concerns about the safety of Stromedix drug, explains Xconomy, causing the developer to fall a year behind schedule.
The good news is that Stromedixs has been granted FDA permission to start a Phase II trials of the drug for ideopathic pulmonary fibrosis, a lung disease which makes breathing difficult. The safety concerns that delayed the kidney trial apply only to transplant patients, and so a clinical trial of STX-100 in lung disease will start later this year. Meanwhile, Gilman says he hopes the FDA will allow the kidney fibrosis study to advance in 2011. "We're pretty psyched because we spent the last year a little bit in limbo, which is frustrating for me and the team, and I would say anxiety-provoking for the investors," Gilman tells Xconomy. He adds that his company, which has raised almost $30 million since 2007, will need additional venture backing in order to support trials of the drug.
- here's the Xconomy article for more