OligoGÂ is a sodium alginate oligosaccharide inhaled dry powder that decreases the thickness of mucus in the lungs of people with cystic fibrosis (CF), and may help them clear mucus more easily. It may also help to improve the effectiveness of some antibiotics.
It is designed to be used with a dry powder inhaler or a liquid for use with a nebulizer.
OligoG Studies
Pre-clinical models and studies on samples from people with CF have shown that OligoG reduces the viscosity of mucus, potentially reduces the amount of bacteria and the need for physical therapy, and improving the effectiveness of antibiotics. As it improves the antibiotic effect on the treatment, it may also increase the effectiveness of removing the bacteria that cause respiratory infections.
Phase 1, 2a and drug deposition studies have shown that OligoG is safe and well tolerated.
A Phase 2b study (NCT02157922), which aims to assess the effectiveness and safety of OligoG as a dry powder formulation in people with CF, is almost finished in five European countries. The expected completion date is January 2017.
The study’s primary objective is to demonstrate inhaled OligoG’s effectiveness measured by forced expiratory volume in one second (FEV1). Secondary objectives include mucociliary clearance, rheology, microbiology, and quality of life.
OligoG has been granted Orphan Drug status from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of CF.
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