Selten Pharma, Inc., a privatively held biopharmaceutical company focused on the development and commercialization of therapies for the treatment of rare diseases, announced today that its lead compound tacrolimus (SPI-026) has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for the treatment of pulmonary arterial hypertension (PAH).
Leo Gu, Ph.D., Co-CEO and President of Selten Pharma, said, "We are pleased to receive Orphan Drug Designation for SPI-026, which highlights the significant need for new medications for patients suffering from PAH. We greatly appreciate the FDA's support of our efforts to evaluate our SPI-026 program for the treatment of PAH. The results of the proof-of-concept, safety, and tolerability study in this indication have been very encouraging."
"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," commented Narinder S. Banait, Ph.D., J.D., Co-CEO and General Counsel of Selten Pharma.
SOURCE Selten Pharma, Inc.