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news.US-based biopharmaceutical firm Selten Pharma has received orphan drug designation from the US Food & Drug Administration (FDA) for tacrolimus (SPI-026), an investigational Bone morphogenetic protein receptor type II (BMPR2) pathway activator for pulmonary arterial hypertension (PAH).
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SPI-026 was discovered by Dr Edda Speikerkoetter and is being developed with the help of Dr Roham Zamanian at Stanford University.
The company said that 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.
According to the company, SPI-026 has been shown to be safe and tolerable in patients with PAH.
Selten Pharma co-CEO and general counsel Narinder Banait said: "We are excited to begin the Phase 2b clinical trial of SPI-026, which we believe has the potential to be the first disease-modifying treatment for patients with this life threatening disease.
"SPI-026 has been shown to activate the BMPR2 pathway and possibly could even reverse the effects of the disease."