FDA clears Vertex IND application for VX-522 to treat CF

Vertex Pharmaceutical announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug IND application for VX-522, a messenger ribonucleic acid mRNA therapy targeted at treating the underlying cause of cystic fibrosis, CF, lung disease for the approximately 5,000 people with CF who cannot benefit from a cystic fibrosis transmembrane conductance regulator CFTR modulator. Vertex plans to initiate a single ascending dose clinical trial for VX-522 in people with CF in the coming weeks. "This partnership brings together Vertex’s scientific expertise and decades of experience in developing cystic fibrosis medicines with Moderna’s proven leadership in mRNA technologies," said Moderna Chief Executive Officer Stephane Bancel. "Moderna’s development of a proprietary inhalable lipid nanoparticle to deliver a functional cystic fibrosis treatment to the lungs could lead to a transformational medical achievement. We are excited by the progress that has been made with the upcoming advancement of VX-522 to the clinic and look forward to our ongoing collaboration to develop treatments for the underlying cause of cystic fibrosis."