First Patient Enrolled in Phase 3 Clinical Trial Evaluating ARINA-1 in Lung Transplant
Source | Business Wire
April 18, 2023 08:52 AM Eastern Daylight Time
CHAPEL HILL, N.C - Renovion, Inc. today announced that 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 (BOS) progression in individuals with a bilateral lung transplant.
"ARINA-1 has the potential to be implemented early in pulmonary function decline in patients who are experiencing early signs of BOS. It has a strong safety profile and poses minimal risk to an unstable patient population," said Marty Zamora, M.D., Chief Medical Officer of Renovion. "Today, there are no FDA-approved therapies to treat patients at the point of this initial drop in lung function. This Phase 3 NDA-enabling trial is an important step in our efforts to provide patients with a safe and effective potential therapy to treat a drop in lung function more proactively."
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.
About Bronchiolitis Obliterans Bronchiolitis obliterans syndrome (BOS) is the most common form of chronic lung allograft dysfunction (CLAD) 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.
About 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. ARINA-1 is poised to start clinical trials in chronic inflammatory airway diseases, including non-cystic fibrosis (CF) 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. For more information about Renovion, visit https://www.renovion.com/ or follow Renovion on Twitter (@RenovionInc).
Contacts Dan Copeland CEO, Renovion email@example.com