-

Renovion Completes Enrollment of Adult Patients in Phase 2 CLIMB Study in Bronchiectasis

CHAPEL HILL, N.C.--(BUSINESS WIRE)--Renovion Inc., a biopharmaceutical company focused on restoring lung health in patients with bronchiectasis and other lung diseases, announced that adult patient enrollment is complete in the Phase 2 CLIMB study of ARINA-1 in non-CF bronchiectasis patients.

CLIMB is a US based, randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability and efficacy of ARINA-1 in participants with bronchiectasis. Efficacy endpoints in this trial include quality of life, sputum rheological markers, blood inflammatory markers and other exploratory clinical markers.

"We are pleased to report that we have completed adult patient enrollment in the CLIMB study for bronchiectasis. This is a great milestone for our company and for people living with bronchiectasis," said Dan Copeland, Chief Executive Officer of Renovion. "CLIMB will provide data regarding ARINA-1 as a first line therapy for bronchiectasis, a serious pulmonary disease that today has no approved treatments. The enthusiasm of the treating community and patient interest in the trial reflect the significant need for a therapy that can help these patients reduce symptoms and improve quality of life. We see ARINA-1 as a potential first line therapy to address the significant impact of bronchiectasis symptoms in the lives of patients, and we look forward to sharing the trial results later this quarter.”

The CLIMB study was conducted at 10 sites in the United States. Renovion is developing ARINA-1 to break the cycle of mucus, inflammation and infection in chronic inflammatory lung diseases by delivering ARINA-1 directly to the lungs of patients. Based on experience in patients to date, ARINA-1 is well positioned to be a first line therapy for patients that need a fast onset of action and an attractive safety profile.

About Renovion

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. Renovion is also conducting clinical trials for ARINA-1 for BOS in lung transplant patients in an ongoing Phase 3 trial and also in patients with chronic bronchitis. 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).

About Bronchiectasis

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. Bronchiectasis affects approximately 340,000 to 520,000 patients in the U.S. There are currently no FDA-approved therapies for bronchiectasis in the US, Europe or Japan.

Renovion Inc.


Release Versions

More News From Renovion Inc.

Renovion Announces Positive Top-Line Results from Phase 2 CLIMB Study of ARINA-1 (RVN-301) in Patients with Non-Cystic Fibrosis Bronchiectasis

CHAPEL HILL, N.C.--(BUSINESS WIRE)--Renovion Inc., a biopharmaceutical company focused on developing therapies to restore lung health in individuals with mucus-related lung diseases, announced topline results of the Phase 2 CLIMB study of ARINA-1 in individuals with non-CF bronchiectasis (NCFBE). ARINA-1 is a novel nebulized therapy in development for reducing mucus symptoms in individuals with NCFBE, chronic bronchitis, lung transplant, and other respiratory diseases with chronic mucus symptom...

First Patient Enrolled in Phase 3 Clinical Trial Evaluating ARINA-1 in Lung Transplant

CHAPEL HILL, N.C.--(BUSINESS WIRE)--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...

Renovion Receives FDA Fast Track Designation for ARINA-1 for the Prevention of BOS Progression in Lung Transplant Patients

CHAPEL HILL, N.C.--(BUSINESS WIRE)--Renovion, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ARINA-1 for the prevention of bronchiolitis obliterans syndrome (BOS) progression in adults with a bilateral lung transplant. The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need. It allows for rolling submission of regulatory documen...
Back to Newsroom