The Food and Drug Administration (FDA) has granted Fast Track designation to ARINA-1 for the prevention of bronchiolitis obliterans syndrome (BOS) progression in adults with a bilateral lung transplant.
ARINA-1 is an at-home nebulized therapy comprised of ascorbic acid and glutathione. It is designed to restore overall lung health by clearing mucus, reducing inflammation, and inhibiting bacterial growth.
The novel therapy is being investigated in the phase 3 ALOFT trial (ClinicalTrials.gov Identifier: NCT05654922) in adults with a bilateral lung transplant. Patients will be randomly assigned to receive ARINA-1 (ascorbic acid 88mg/mL, reduced glutathione 150mg/mL) 4mL solution inhaled twice daily via nebulization plus the standard 3-therapy immunosuppression regimen and azithromycin or standard of care only. The primary endpoint is the percentage change from baseline in FEV1 at 24 weeks.
“We are pleased with the FDA’s decision to grant Fast Track designation for ARINA-1 in bilateral lung transplant patients with early BOS, and we look forward to enrolling our first patient in the next few weeks,” said Marty Zamora, MD, Chief Medical Officer at Renovion. “This allowance complements our Orphan Drug status in lung transplant and current focus on enrollment at lung transplant centers across the US in the ALOFT trial. This advances our clinical strategy to develop therapies for patients with a critical unmet need. The safety of this drug to date and the efficacy in this trial can make a tremendous difference in the lives of patients with limited or no treatment options.”
The Company is also investigating ARINA-1 in chronic inflammatory diseases, including non-cystic fibrosis bronchiectasis (ClinicalTrials.gov Identifier: NCT05495243) and non-tuberculous mycobacteria-lung disease.
Renovion receives FDA Fast Track designation for ARINA-1 for the prevention of BOS progression in lung transplant patients. News release. Renovion, Inc. Accessed March 30, 2023. https://www.businesswire.com/news/home/20230330005111/en/Renovion-Receives-FDA-Fast-Track-Designation-for-ARINA-1-for-the-Prevention-of-BOS-Progression-in-Lung-Transplant-Patients