Our lead product is a rationally selected bacterial strain (FX856) with anti-inflammatory properties demonstrated in standard gastrointestinal disease models. FX856 is functional during active disease, has an excellent safety profile, and a scalable manufacturing process. FX856 benefits from regulatory exemptions (GRAS in USA, QPS in Europe) meaning it has a shortened development pathway; independent regulatory advice indicates no requirement for preclinical safety testing or healthy volunteer trials for development as a therapeutic.
Our food supplement is classified as Generally Regarded as Safe (GRAS) by the FDA and therefore does not require additional safety and tolerance studies allowing immediate access to the food supplement market.
FX856 is manufactured through an identified contract manufacturer and will be supplied in blister packs of 30 capsules (one month's supply).
Our products have three unique key attributes:
• Capable of surviving and thriving in the actively inflamed gut
• Demonstrated mucosal healing
• Excellent safety profile
FX856 is well placed to be used as a cost-effective single or adjunctive early therapy in efforts to initiate or prolong remission.
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