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Biogen Idec. Gilman, a former Biogen research executive, had initially talked up the potential benefits of the drug in treating scarring of the kidneys that causes the organs to fail. But U.S. regulators later gave the company the green light for a mid-stage study of the drug in patients with IPF, while they raised safety concerns about the treatment in prolonging the function of transplanted kidneys. So now the company is emphasizing its development for IPF patients. Gilman hasn’t said what the FDA’s specific safety concerns are.
Stromedix has approval from the FDA for its mid-stage IPF trial, which will be double-blinded, randomized, and placebo-controlled, according to Gilman. The study will seek to find an optimal dose for treating the lung disease and provide some early clues about whether it’s an effective treatment for the disease. To see whether the drug is working, the company plans to measure certain biomarkers from protein and cell samples taken from the lungs of patients. (Collecting the samples is done relatively simply by squirting a water-based solution into the lungs, letting it move around, and then extracting the fluid containing the patient’s cells and proteins used in the analyses.)
Idiopathic pulmonary fibrosis, of which the cause is not fully known, is typically treated today with corticosteroids to reduce inflammation, or, in more severe cases, with lung transplants. Yet the steroids don’t cure chronic disease, and lung transplants are costly and availability of organs is limited.
Gilman says that the debt financing his company has completed gives his investors and the company some nice options. The deal gives the company the ability to draw down the money it needs for the mid-stage study of STX-100 in IPF. But, if the company finds a new equity investor or a pharmaceutical partner to provide more funding for the trial, it might not have to use as much of the debt as it would otherwise need, Gilman says.