IVIG (Primary Immunodeficiency Diseases):
Intravenous immunoglobulin (IVIG) is a blood product administered intravenously. It contains the pooled, polyvalent, IgG antibodies extracted from the plasma of over one thousand blood donors. IVIG’s effects last between 2 weeks and 3 months. It is mainly used as treatment in four major disease categories: 1- Primary Immune deficiencies such as X-linked agammaglobulinemia (XLA), Common variable immunodeficiency (CVID) and hypogammaglobulinemia, 2-Acquired compromised immunity conditions (secondary immune deficiencies) featuring low antibody levels, 3- Autoimmune diseases, e.g. immune thrombocytopenia, inflammatory diseases, Kawasaki disease, and Guillain-Barre SyndromeAND 4- Acute infections.
Our upper estimates suggest that six million people may be living with a PID worldwide, whereas only 27,000-60,000 have been identified to date.
Prometic has completed the enrolment of the adult patient population (50 adult patients) in its pivotal IVIG phase III clinical trial for the treatment of primary immunodeficiency diseases (“PIDD”).
The ongoing pivotal Phase III clinical trial is an open label, single arm, two-cohort multicenter study investigating the safety, tolerability, efficacy and pharmacokinetics of Prometic’s plasma derived IVIG in a total of 75 patients suffering from PIDD, including 50 adults (cohort 1) and 25 children (cohort 2). Prometic anticipates the completion of enrollment of cohort 2 to rapidly follow having now completed the enrolment of adult patients.