Renovion Receives Notice of Study May Proceed Status for Lung Transplant Program
Renovion, Inc., a clinical-stage pharmaceutical company focused on developing treatments for serious chronic inflammatory lung diseases with high unmet needs, announced today that they have received a Study May Proceed Letter from the U.S. Food and Drug Administration (FDA) for a Phase 3 clinical trial to investigate ARINA-1 in the prevention of Bronchiolitis Obliterans Syndrome (BOS) progression in patients that have had a bilateral lung transplant. ARINA-1 is a nebulized therapy that has been shown to be safe and improve pulmonary function and quality of life in patients with a lung transplant.
BOS is one of the key factors contributing to 45% mortality in lung transplant patients at 5 years post-transplant, and there are no FDA-approved treatment options for BOS. Renovion will focus on treating people with a bilateral lung transplant who have experienced a recent 10-20% decline in FEV1 to prevent pulmonary function decline and disease progression. The ARINA-1 trial will be the first of its kind in this patient population and will enroll from sites across the US.
“The Study May Proceed notice for the clinical trial in people with a bilateral lung transplant is a significant regulatory milestone for Renovion. This allowance complements our orphan drug status in lung transplant and advances our clinical strategy to develop therapies for patients with a critical unmet need. We are excited to start participant recruitment at lung transplant centers across the US in the coming weeks and are focused on making a difference in the lives of patients with limited or no treatment options,” said Carolyn Durham, PhD, Chief Scientific Officer of Renovion, Inc.
Renovion is a clinical-stage pharmaceutical company focused on developing ARINA-1, novel nebulized therapy delivered to the lungs to treat pulmonary diseases. ARINA-1 clears mucus and reduces damaging inflammation in the airways to restore lung health. In addition to lung transplant, Renovion is poised to start clinical trials in chronic inflammatory airway diseases, including non-cystic fibrosis bronchiectasis (NCFBE) and non-tuberculosis mycobacteria-pulmonary disease (NTM-PD). The Renovion team has in-depth experience in drug development with extensive scientific expertise in chronic pulmonary conditions and inflammation. For more information on Renovion, visit https://www.renovion.com/ or follow Renovion on Twitter.