Renovion has enrolled the first patient in a Phase III trial of ARINA-1, which is designed to prevent the progression of bronchiolitis obliterans syndrome (BOS) in patients with a bilateral lung transplant.
The study will assess the safety and efficacy of the investigational nebulised therapy ARINA-1 in around 100 individuals across 15 US sites.
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Renovion chief medical officer Marty Zamora said: “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.
“Today, there are no FDA-approved therapies to treat patients at the point of this initial drop in lung function.
“This Phase III 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.”
ARINA-1 restores lung health by clearing mucus and helps in reducing airway inflammation.
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By GlobalDataThe company is also planning to initiate trials of ARINA-1 for treating chronic inflammatory airway diseases, including non-tuberculous mycobacteria-pulmonary disease and non-cystic fibrosis bronchiectasis.
The off-label therapies that are used for the treatment of BOS, the most common form of chronic lung allograft dysfunction, are showing serious side effects like infections.
Within five years of a lung transplant, around 50% of all lung transplant patients are developing BOS.
