Alginate products with high G-content derived from seaweed harvesting are unable to meet current market demands. Global demand is already outstripping supply of food grade alginates, and there is increasing demand resulting from new applications within the food, pharmaceuticals, biotechnology and cosmetics industries. Existing harvesting methods have high production costs, are labour-intensive, and have low extraction yields (especially for low molecular weight G-rich alginates, where 75% of product is wasted). The global alginate market is projected to grow significantly and reach approximately €1 billion by 2028. AlgiPharma has been approached by several major pharmaceutical, biomedical, cosmetic and food clients who are eager for more sustainable and precisely defined alginate products, for their functionality, and in one case to replace components derived from petrochemicals. AlgiPharma has developed a land-based fermentation process but need to scale up this process to serve the global market. This is expected to create significant European competitive advantage in the global production of alginates. AlgiPharma has partnered with a consortium of industrial European partners to establish a unique European manufacturing base to supply these well-defined alginates. AlgiPharma's innovative approach is a sustainable land-based production method, providing a sustainable, scalable and cost-efficient production of highly sought after products. This new method also offers significant environmental and social benefits, providing an environmentally friendly and cost-effective alternative to traditional seaweed harvesting. EIC funding is essential to meet the high initial costs, de-risking the project for future investment, and will enable AlgiPharma to accelerate the scale-up process to promptly meet market demand for large scale production.

The objective of the current proposal is to advance the orphan drug OligoG CF-5/20 (OligoG) through a pivotal phase IIb clinical trial, to enable a new and improved therapeutic approach for the orphan disease cystic fibrosis by 2024. The study drug is an alginate oligosaccharide derived from seaweed. Several properties relevant to the treatment of CF have been demonstrated using in vitro and ex vivo model systems including release of stagnant mucus, disruption of bacterial biofilm and increased bacterial susceptibility to antibiotics. OligoG received an EU Orphan Drug Medicinal Product Designation in 2007 and an FDA Orphan Drug Designation February 2016, for the treatment of cystic fibrosis. The planned clinical trial will include approx 200 CF patients from approx. 35 European sites in coordination with the European Clinical Trial Network. The final study design, selection criteria, procedures and endpoints will be based on results from a recently finalized phase II study and will follow scientific advice and protocol assistance sought at the European Medicines Agency (EMA). A set of clinical and exploratory endpoints will be defined to assess the various effects of OligoG, comprising lung function assessed by spirometry and Lung Clearance Index (LCI) measurements, infection status assessed by frequency of pulmonary exacerbations and non-culture-dependent microbiology, and patient reported outcomes assessed by questionnaires, including standardised CF questionnaires (CFQ-R). A successful trial will enable preparation of international applications for conditional marketing authorisation (cMAA) throughout Europe and a New Drug Application (NDA) in the US, for the treatment of cystic fibrosis lung disease. In accordance with the work programme, a successful project will thus imply a new and improved therapeutic approach within cystic fibrosis available for CF patients by 2024.