20 April 2023 - - The first patient has been enrolled in a Phase 3 clinical study evaluating ARINA-1, an investigational nebulized therapy to prevent the progression of bronchiolitis obliterans syndrome progression in individuals with a bilateral lung transplant, US-based Renovion, Inc said.

The Phase 3 study is a randomized, multicenter study evaluating the efficacy and safety of ARINA-1 in the prevention of BOS progression in individuals with a bilateral lung transplant.

The study is expected to enroll approximately 100 participants across 15 sites in the US.

Bronchiolitis obliterans syndrome is the most common form of chronic lung allograft dysfunction after lung transplantation and is the leading cause of graft failure and mortality in lung transplant with approximately 50% of all lung transplant patients developing BOS within 5 years of transplant.

BOS is a rapidly progressive inflammatory rare disease that irreversibly destroys the airways of the lungs and usually leads to respiratory failure and death within 2 to 4 years after diagnosis.

Currently, there are no FDA-approved therapies to treat pre-BOS or BOS. The off-label therapies used to treat BOS are often toxic with serious side effect risks, including significantly increasing infection risk.

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.

ARINA-1 is poised to start clinical trials in chronic inflammatory airways diseases, including non-cystic fibrosis bronchiectasis (NCFBE) and non-tuberculous 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.