Xeragenx ProcessXGX-001 is being developed as a new drug for various indications relating to the maintenance, restoration, and supplementation of vitamin B12. The product delivers a receptor-targeted oral form of vitamin B12 for absorption via the body’s natural and intended physiologic pathway.

XGX-001 is formulated as an enteric coated tablet with vitamin B12 as hydroxocobalamin (OHCbl) pre-bound to its natural binding protein, intrinsic factor. The source of human IF is a recombinant form (rhIF) that has been transgenically expressed in the plant Arabidopsis thaliana.[5] The Xeragenx rhIF protein has been shown to bind B12 correctly and in turn bind to the cubilin receptor with as good or better affinity than human IF.[5]

The enteric coating of XGX-001 is designed to degrade upon entering the duodenum at a pH range of 4.5–5.5, releasing the bound OHCbl-rhIF complex to continue uninterrupted to the terminal ileum where it binds to the cubilin receptor. The rhIF is subsequently degraded in enterocyte lysosomes, and the vitamin B12 (OHCbl) is released into plasma where it is partially bound to transcobalamin and transported for intracellular absorption.

A receptor-targeted oral B12™ pre-bound to rhIF can overcome the number of obstacles that prevent the vitamin from being properly bound, transported, absorbed, and utilized. XGX-001 will deliver a highly absorbable oral B12 at the body’s intended physiologic dose and avoid the consequences associated with ingesting B12 in mega dose quantities, which are often a thousand times greater than the physiologic receptor capacity.