Researchers will conduct a trial to study the efficacy of ARO-MMP7 inhalation solution in both healthy subjects and patients with idiopathic pulmonary fibrosis (IPF).
The sponsor of this study is Arrowhead Pharmaceuticals. ARO-MMP7 is the company’s experimental RNA interference treatment that is designed to lower the expression of matrix metalloproteinase 7 (MMP7). MMP7 is a predictive biomarker of disease progression in patients with IPF.
The purpose of this study is to assess the pharmacokinetics and pharmacodynamics of ARO-MMP7 in both healthy individuals and patients with IPF. In addition, this study aims to understand the safety and tolerability of the investigational therapy. The dose level and interval will be selected by Arrowhead based on available pharmacodynamics and safety data.
The phase 1/2a study plans to recruit 77 participants and is estimated to start in November 2022 and end in August 2024. Participants with IPF must be 45 years of age or older at screening and have a clinical diagnosis consistent with IPF upon review of high-resolution computer tomography and lung biopsy results. In addition, participants with IPF must have stable disease and be able to safely undergo bronchoscopy.
Read more about IPF etiology
This study is quadruple masked (investigator, outcome assessor, participant, and care provider), and participants will be randomized to receive a placebo or the experimental treatment. Both the placebo and ARO-MMP7 will be administered via inhalation of nebulized solution. The placebo will consist of calculated volumes of normal saline to match the active treatment.
The primary outcome measure of this study is the number of participants with treatment-emergent adverse effects over time. Secondary outcome measures include changes in lung function parameters from baseline, as well as a number of parameters regarding the pharmacokinetics of the potential therapy.
Study of ARO-MMP7 inhalation solution in healthy subjects and patients with idiopathic pulmonary fibrosis. ClinicalTrials.gov. September 13, 2022. Accessed September 26, 2022.