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LCTG-001 is a mucosal antibody replacement therapy comprised of polyclonal secretory Immunoglobulin A (sIgA), developed for nasal administration. It is designed as a first-in-class, mucosally targeted replacement therapy to address primary immunodeficiency diseases, particularly Common Variable Immunodeficiency (CVID). The drug leverages sIgA’s natural role in coating mucosal surfaces to neutralize pathogens, modulate inflammation, and maintain microbiome balance. Patients with CVID and similar conditions lack this critical immunological barrier, making them highly susceptible to chronic infections and inflammatory complications. LCTG-001 is derived from human breast milk antibodies using proprietary technology and represents an innovative approach by targeting the immune system at the point of pathogen entry rather than systemic delivery. The product has received Orphan Drug Designation and Rare Pediatric Disease Designation from the US FDA for CVID[1][2][4][5].
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