Chronic allograft nephropathy, also known as chronic allograft dysfunction, is a fibrotic condition that is a cause of kidney transplant failure.
STX-100 is a humanized monoclonal antibody licensed in 2007 from Biogen Idec. Stromedix initiated a Phase I clinical trial of STX-100 in early 2008.
Orphan drug status confers seven years of market exclusivity following FDA approval as well as certain tax advantages to companies that take on the challenge of developing life-saving drugs for small patient populations.
Michael Gilman, CEO of Stromedix, said: “There is a clear medical need for therapies that prolong graft function in kidney transplant patients and that more broadly inhibit fibrosis in other clinical settings. We have made rapid progress on STX-100 since obtaining the program from Biogen Idec last year. This action by the FDA should facilitate the development of this drug for transplant patients.”