Stromedix has announced that it has received orphan drug designation from the US Food and Drug Administration (FDA) for its lead clinical candidate, STX-100, to treat idiopathic pulmonary fibrosis.
STX-100 is a humanised monoclonal antibody which targets integrin avß6 to inhibit fibrotic activity.
Having completed the phase I trial of STX-100, Stromedix plans to conduct the phase II trial in IPF patients in 2011.
Orphan drug designation is granted by the FDA to drugs that treat diseases affecting less than 200,000 people in the US and address an unmet clinical need.
Idiopathic pulmonary fibrosis is a debilitating and uniformly fatal disease and affects about 115,000 people in the US.