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Vertex Pharmaceuticals (NASDAQ:VRTX) said Thursday the U.S. Food and Drug Administration (FDA) greenlighted a clinical trial for its kidney disease candidate VX-407, further expanding its R&D work related to renal diseases.
Its investigational new drug (IND) application is related to investigations into the potential of VX-407 in autosomal dominant polycystic kidney disease (ADPKD), a hereditary form of kidney disease that can require dialysis and transplantation and can ultimately lead to death.
The company plans to start a Phase 1 trial for the small-molecule candidate in healthy volunteers this month.
Vertex (VRTX), a company known for its cystic fibrosis therapies, brings its 10th disease area into the clinic with the IND clearance.
Boston, Massachusetts-based biotech’s pipeline includes oral experimental therapy inaxaplin targeted at APOL1-mediated kidney disease, a chronic kidney disease caused by mutations in the APOL1 gene.