According to a July 13 news release, biopharmaceutical company Kedrion Biopharma (“Kedrion”) recently treated its first pediatric patient within the Phase 3 KIDCARES10 clinical trial. Within the trial, Kedrion is evaluating the safety, efficacy, tolerability, and pharmacokinetic profile of KIG10, a 10% intravenous immunoglobulin (IVIG), for pediatric patients (under 18) with primary immunodeficiency (PI).
KIG10, an IVIG Therapy
Altogether, 30 patients will enroll in KIDCARES10. Patients will come from Italy, Russia, the Slovak Republic, Portugal, and Hungary, although data will later be submitted to the United States’ FDA. During the trial, researchers will evaluate KIG10, an IVIG therapy, for patients with PI. As PI becomes more well-known, incidences and diagnoses are rising. Thus, there is an immediate need for more effective and available treatment options.
According to the American College of Rheumatology (ACR), intravenous immunoglobulin (IVIG) is:
a therapy treatment for patients with antibody deficiencies…prepared from a pool of immunoglobulins (antibodies) from the plasma of thousands of healthy donors. Immunoglobulins are made by the immune system of healthy people for the purpose of fighting infections.
Now, the first patient within the KIDCARES10 trial has received their first treatment. During the course of the trial, patients will be treated over a 12-month (1-year) period. Researchers hope to understand:
- The overall safety of this IVIG therapy
- Whether KIG10 can reduce the amount of serious bacterial infections (such as bacterial pneumonia, osteomyelitis, or bacterial meningitis) faced by patients over the yearlong period
- How KIG10 is distributed, metabolized, and eliminated from the body
- In what ways this treatment improves vital signs and laboratory measures
Primary Immunodeficiency (PI)
There are over 350 types of primary immunodeficiency (PI) diseases, or inherited immune system disorders which prevent the body from adequately fighting infections. PI is typically caused by gene mutations. For example, over 10 separate gene mutations are associated with common variable immunodeficiency disease (CVID). Patients with CVID often experience ear, sinus, and lung infections. However, they are also at an increased risk of autoimmune diseases or cancers like stomach cancer. Alternately, about 45% of patients with severe combined immunodeficiency disease (SCID) have an X chromosome mutation which affects the T-cell growth factor receptor. Patients with SCID have an abnormal and almost completely missing immune system.
Regardless of the type of PI, patients experience non-functioning or low-functioning immune systems, increasing the risk of dangerous infections.