Pharma Focus America

Renovion Announces First Patient Enrolled in Phase 2 Clinical Study Evaluating ARINA-1 for the Treatment of Non-CF Bronchiectasis

Thursday, November 03, 2022

Renovion and COPD Foundation Joint Release – Renovion, Inc. has announced that the first patient has been enrolled in a Phase 2 clinical study evaluating ARINA-1, an investigational nebulized therapy, to treat adults with non-CF bronchiectasis (NCFBE) (NCT05495243).

"ARINA-1 has been shown to have significant mucolytic activity, as well as robust anti-inflammatory properties," said Carolyn Durham, Ph.D., Chief Scientific Officer of Renovion. "Mucus and inflammation are hallmarks of NCFBE, and by directly targeting mucus and inflammation with a therapy nebulized directly to the airway, ARINA-1 has the potential to change the course of disease for these patients and alleviate mucus symptoms. Currently, there are no FDA-approved therapies for treating NCFBE and its associated mucus symptoms."

The Phase 2 study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The objectives are to evaluate the safety and efficacy of ARINA-1 nebulized twice daily by adults with NCFBE who experience excess mucus and cough. The study is expected to enroll approximately 55 participants across nine sites in the US.

“As a partner with Renovion through our therapeutics and digital health accelerator 360Net, we’re pleased to see that the ARINA-1 Phase 2 clinical study has its first patient enrolled. Many patients in our bronchiectasis and COPD communities struggle on a daily basis with mucus production and chronic inflammation (commonly referred to as chronic bronchitis). New therapies that improve mucus clearance can ultimately improve a patient’s quality of life,” said Bruce Miller, Ph.D., Chief Scientific Officer of the COPD Foundation.

NCFBE and COPD are associated with a significant global burden. More than 380 million people have COPD, the 3rd leading cause of death worldwide, and approximately 20% of all individuals with COPD have bronchiectasis. Although non-CF bronchiectasis is often referred to as a rare disease, in the U.S., NCFBE affects nearly 150 individuals per 100,000, and global prevalence is expected to grow by 10-20% in the next 10 years.

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