Renovion initiates Phase 3 trial of ARINA-1 nebulized mucolytic in patients who have had a bilateral lung transplant

Renovion has initiated a Phase 3 clinical study of its ARINA-1 inhaled glutathione / bicarbonate / ascorbic acid for the treatment of bronchiolitis obliterans syndrome (BOS) following bilateral lung transplant. ARINA-1 recently received Fast Track designation for that indication. Plans for the Phase 3 trial were announced in August 2022. According to the company, the trial is expected to enroll approximately 100 patients and will evaluate the efficacy of ARINA-1 in stopping BOS from progressing in those patients.

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 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.”

ARINA-1 is also in development for the treatment of non-CF bronchiectasis, and the company announced initiation of a Phase 2 trial for that indication in November 2022.

Read the Renovion press release.