Renovion announced that the company has gotten the go-ahead from the FDA to initiate a Phase 3 clinical trial of its ARINA-1 nebulized glutathione / bicarbonate / ascorbic acid for the prevention of bronchiolitis obliterans in bilateral lung transplant patients who have recently had a reduction in lung function. ARINA-1, which is delivered via the PARI eFlow nebulizer system, was awarded orphan drug designation from the FDA for the treatment of lung dysfunction following lung transplant in 2017.
Renovion Chief Scientific Officer Carolyn Durham commented, “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.”
The company is also developing ARINA-1 for the treatment of non-CF bronchiectasis and COPD and is partnered with the COPD Foundation for development of the inhaled mucolytic for those indications.
Read the Renovion press release.
