The Phase II clinical trial of our investigational treatment for cystic fibrosis, SPX-101 Inhalation Solution, has completed enrollment.
A randomized, double-blind, placebo-controlled phase II study to evaluate the efficacy and safety of SPX-101 Inhalation Solution in subjects with cystic fibrosis took place in Canada, the United Kingdom, France, Portugal, and Italy.
This study evaluates the efficacy, safety, and tolerability of SPX-101 Inhalation Solution for 28 days in adults 18 – 50 years of age who have a confirmed diagnosis of cystic fibrosis. All CFTR mutations were eligible for this study.
• Placebo inhalation solution twice daily for 28 days
• SPX-101 Inhalation Solution (High Dose) twice daily for 28 days
Participants met the inclusion and exclusion criteria detailed below:
– Dr. Tim Lee, Director of the Clinical Trials Network (CTN) of the European Cystic Fibrosis Society
SPX-101 is a therapeutic peptide that binds to epithelial sodium channels (ENaC) on the airway surface, causing a decrease in channel density by cellular internalization. This novel mechanism durably reduces absorption so that fluid is retained on the airway surface. Enhancing fluid levels restores hydration to the resident mucus and promotes its clearance by airway cilia, a process called mucociliary clearance. SPX-101 is in clinical development to treat CF-related lung disease for all people with this disease, regardless of their specific CFTR mutation.
CF is a genetic disease that impacts the body’s ability to regulate the flow of salt and water across epithelial membranes, resulting in loss of fluid volume. The respiratory tract is one of the most profoundly affected, causing dehydration-induced lung disease that begins with depleted airway surface liquid and accumulations of dry, sticky mucus and leads to chronic inflammation, recurrent infections, and reduced ability to breathe.