Redx has received Orphan Drug Designation from the US Food and Drug Administration (FDA) for the potential treatment of Idiopathic Pulmonary Fibrosis (IPF) for Zelasudil, which is currently in a Phase 2a clinical study for IPF, with topline data expected in Q1 2024.
The FDA can grant Orphan Drug Designation to support the development and evaluation of new treatments to prevent, diagnose or treat a rare disease or condition that affects fewer than 200,000 in the US. The designation provides Redx with various development and commercial incentives, including market exclusivity, in order to address this unmet need for patients suffering from IPF.
Dr Jane Robertson, Chief Medical Officer, Redx Pharma commented: “We are delighted that the FDA has recognised the potential of zelasudil for the treatment of IPF and granted Orphan Drug Designation. Selectively targeting ROCK2 is an exciting, novel approach which could provide a new treatment option for patients with IPF, and with potential applications in other interstitial lung diseases and cancer-associated fibrosis. We are encouraged by both the strength of our preclinical package as well as the clinical results to date and we look forward to reporting Phase 2a topline data in Q1 2024.”