Pfizer and Gliknik entered into an exclusive worldwide license agreement to allow Pfizer to develop and, if approved by applicable regulatory authorities, commercialize GL-2045/PF-06755347. The U.S. Food and Drug Administration granted Orphan Drug designation to GL-2045/PF-06755347 for the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
Pfizer has advanced GL-2045/PF-06755347 in a Phase 1 trial to evaluate multiple single dose cohorts, including both intravenous and subcutaneous administration, with enrollment eligibility for healthy participants as well as patients with idiopathic thrombocytopenic purpura (ITP).
There are numerous marketed brands of IVIG with some products approved for use in the autoimmune indications including CIDP, multifocal motor neuropathy (MMN), and ITP. Patients want a medicine that has a safer and more convenient administration profile compared to that of IVIG. While IVIG is produced by pooling and purifying plasma from tens of thousands of human blood donors, GL-2045/PF-06755347 is recombinant, so it does not carry the risk of blood-borne pathogen transmission. Its increased potency may enable infusion of smaller volumes over shorter infusion periods or subcutaneous injections, thereby potentially improving ease of administration and quality of life for these patients. We hope that GL-2045/PF-06755347 will meet or exceed the efficacy of the blood product IVIG in treating autoimmune diseases.
IVIG is also approved for treating immunodeficiency disorders, acting primarily through the Fab portion of IgG1. GL-2045/PF-06755347 does not contain an Fab and was not designed to treat these patients. Since GL-2045/PF-06755347 is a recombinant product, it can be produced in limitless quantities. If successfully commercialized, GL-2045/PF-06755347 might 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.