Orphan Status Granted to Investigational Pulmonary Arterial Hypertension Drug
Selten Pharma announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to tacrolimus (SPI-026) for the treatment of pulmonary arterial hypertension.
Selten's SPI-026 program is evaluating SPI-026, an investigational bone morphogenetic protein receptor type II (BMPR2) pathway activator for the treatment of patients with pulmonary arterial hypertension. In studies, SPI-026 prevented the development of PAH in mice with a deletion of BMPR2 endothelial cells in a chronic hypoxia model, and reversed PAH and neointimal/occlusion in the lungs in rats with neointima formation following VEGF receptor blockade and chronic hypoxia. It has been shown to be safe and tolerable in patients with PAH.
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