Renovion has announced the completion of adult patient enrolment for its Phase II CLIMB study, which is designed to assess the therapeutic ARINA-1 in individuals with non-CF bronchiectasis.
The US-based, randomised, double-blind, placebo-controlled trial will evaluate the therapy’s safety, tolerability and efficacy.
The CLIMB study aims to determine the impact of ARINA-1 on quality of life, sputum rheological markers, blood inflammatory markers and other exploratory clinical markers in bronchiectasis patients, as efficacy endpoints.
Renovion's ARINA-1 is designed to disrupt the cycle of mucus, inflammation and infection prevalent in chronic inflammatory lung diseases by delivering the therapy directly to the lungs.
It is expected to hold the potential to become a first-line treatment for patients requiring rapid onset of action coupled with a favourable safety profile.
Renovion CEO Dan Copeland said: “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.
“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.”
In April 2023, Renovion enrolled the first patient in a Phase III trial of ARINA-1, which is intended to help prevent the progression of bronchiolitis obliterans syndrome in patients with a bilateral lung transplant.