First Patient Enrolled in Phase 2 Clinical Study Evaluating ARINA-1 for the Treatment of NCFBE
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.
About NCFBE Patients Non-CF bronchiectasis (NCFBE) is a chronic pulmonary disorder characterized by a vicious cycle of mucus, inflammation, and infection that results in permanently dilated airways. Individuals with NCFBE experience significant and life-altering mucus symptoms and chronic cough. Stagnant mucus often traps bacteria and leads to frequent exacerbations and increased shortness of breath, which often leads to clinical decline. There are currently no FDA-approved therapies for NCFBE.
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 airways diseases, including pre-bronchiolitis obliterans syndrome (pre-BOS) in bilateral lung transplant, non-cystic fibrosis (CF) bronchiectasis (NCFBE) (NCT05495243) and non-tuberculosis 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 our website or follow Renovion on Twitter (@RenovionInc).
About The COPD Foundation and COPD360Net The COPD Foundation is a not-for-profit organization established to improve the lives of people with COPD, bronchiectasis, and nontuberculous mycobacterial (NTM) lung disease through initiatives that expand services and speed innovations that will make treatment more effective and affordable. The Foundation does this through scientific research, education, advocacy, and awareness with the goal of disease prevention, slowed progression, and ultimately a cure. The COPD Foundation’s Therapeutics and Digital Health Accelerator Network (360Net) supports the development and adoption of novel digital health tools, medical devices, and therapeutics that treat COPD, bronchiectasis, and NTM lung disease. This network consists of COPD Foundation accredited centers; experts in COPD and related lung diseases; relevant subject matter experts, including primary care physicians; clinical trial designers; health economists; and psychosocial experts.
Contacts Dan Copeland CEO, Renovion firstname.lastname@example.org
Carol Johnson Sr. Director of Communications and Marketing, COPD Foundation 1-786-749-7104 email@example.com