Arrowhead Pharmaceuticals Files for Regulatory Clearance to Begin Phase 1/2a Study of ARO-ENaC for Treatment of Cystic Fibrosis
Pending clearance, Arrowhead intends to proceed with AROENaC1001, a Phase 1/2a dose-escalating study to evaluate the safety, tolerability, and pharmacokinetic effects of ARO-ENaC in normal healthy volunteers and to evaluate the safety, tolerability, and efficacy in patients with CF. Exploratory objectives in patients with CF include assessing the effects of ARO-ENaC on changes in lung clearance index (LCI) and evaluating changes in forced expiratory volume (FEV1)
The application for approval of the clinical trial is being submitted to a local Ethics Committee and to the
ARO-ENaC is designed to reduce activity of the epithelial sodium channel alpha subunit (αENaC) in the airways of the lung. In patients with CF, CFTR dysfunction causes increased ENaC activity which contributes to airway dehydration and reduced mucociliary transport. This predisposes patients to persistent lung infections, structural damage, and progressive loss of pulmonary function. ENaC has been extensively explored as a potential therapeutic target for CF, but the development of inhaled small molecule ENaC inhibitors has been limited by on-target renal toxicity and short duration of action in the lung.
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