The FDA acknowledged a shortage of IVIg in 2019 as a result of growing IVIg demand and then the shortage worsened during the pandemic as plasma collections fell off. Every other country uses even less IVIg per capita than the United States because of product shortage, high costs, and avoidance of blood products. There is a clear need for a recombinant equivalent of IVIg
Researchers have increasingly realized that the active fraction of IVIg in the treatment of autoimmune diseases is the multimeric Fc found in low abundance in IVIg*. One implication of this finding is that the vast majority of IVIg protein infused may not be active in the treatment of autoimmune diseases.
IVIg remains among the top 5 selling drugs. GL-2045 aims to be at least as effective as IVIg in autoimmune conditions with an even safer profile and the convenience of at-home SC injections.
IVIg remains among the top 5 drugs in annual worldwide revenue, about 75 years after its commercial launch. Despite introduction of many single mechanism drugs that have one of IVIg’s many effects, IVIg continues to grow steadily in volume, year after year, as supply becomes available. IVIg has regulatory approval in seven autoimmune indications and proven efficacy in dozens of autoimmune indications.**
While IVIg is produced by pooling and purifying plasma from tens of thousands of human blood donors and is therefore never exactly the same from batch to batch, GL-2045 is recombinant (cell grown), so it can be produced in unlimited quantities that do not vary and does not carry the risk of blood-borne pathogen transmission.
Patients want a medicine that has IVIg efficacy with a safer and more convenient administration profile compared to that of IVIg. Because GL-2045 is designed to mimic only the active fraction of IVIg, it is expected to require significantly less drug than IVIg in the treatment of autoimmune diseases. Its increased potency may enable infusion of smaller volumes by subcutaneous injections, thereby potentially improving ease of administration and quality of life for these patients. Our goal is to demonstrate that GL-2045 meets or exceeds the efficacy of the pooled human blood product IVIg in treating autoimmune diseases with greater patient convenience and without exposure to blood products.
If successfully commercialized, GL-2045 will allow more of the IVIg products, currently used to treat both immunodeficiency disorders and autoimmune indications, to be available for individuals living with immunodeficiency disorders, thereby helping to address a chronic worldwide IVIg supply shortage.
* Augener, 1985; Bussel, 1991; Debré, 1993; Teeling, 2001; Kroez, 2003; Bazin, 2004; Siragam, 2005; Clynes, 2005; Bazin, 2006; Siragam, 2006