Stromedix Inc, a biotechnology company focused on innovative therapies for fibrosis and fibrotic organ failure, announced that its lead clinical candidate STX-100 has been granted orphan drug status by the US Food and Drug Administration (FDA) for the treatment of chronic allograft nephropathy.

Chronic allograft nephropathy (CAN), also known as chronic allograft dysfunction, is a fibrotic condition that is a leading cause of kidney transplant failure. Approximately 20 per cent of patients on the waiting list for kidney transplantation in the United States are awaiting a retransplant of a failed graft. There are no FDA-approved therapies for CAN.

STX-100 is a novel humanized monoclonal antibody licensed in 2007 from Biogen Idec. STX-100 targets integrin ?v?6 and exhibits significant anti-fibrotic activity in preclinical animal models of kidney, lung and liver disease. Stromedix initiated a phase-1 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.

"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," said Michael Gilman, Ph D, CEO of Stromedix. "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."

Stromedix, based in Cambridge, Massachusetts, is a biotechnology company focused on innovative therapies for fibrotic organ failure. Stromedix' investors include Atlas Venture, New Leaf Venture Partners, Frazier Healthcare Ventures, Bessemer Venture Partners and Red Abbey Venture Partners. Biogen Idec is also a shareholder.