GC Biopharma said on Monday that its I.V.-Globulin SN inj. 10% (ingredient: human immunoglobulin-G) for treating autoimmune encephalitis patients demonstrated safety and efficacy in prospective clinical trials.
Autoimmune encephalitis is a disease that causes neurological deficits through autoimmune mechanisms, and the incidence rate is gradually increasing. Autoimmune encephalitis can cause various neurological abnormalities such as memory loss, consciousness level disorder, convulsions, motor dysfunction, and in severe cases, death during treatment.
In this study, I.V.-Globulin SN inj. 10% was administered to patients diagnosed with autoimmune encephalitis for five days, and all five neurological indicators, including the modified Rankin Scale (mRS), showed statistically significant symptom improvement effects from day 3 until day 29. The side effects were confirmed to be only temporary minor symptoms that appeared during intravenous administration, confirming the safety of I.V. Globulin SN inj once again.
In this study, patients diagnosed with autoimmune encephalitis were given I.V.-Globulin SN inj. 10% for five days and showed statistically significant symptom improvement in all five neurological indicators, including the modified Rankin Scale (mRS), after three days, and the effect lasted up to 29 days. There were only temporary mild symptoms due to intravenous administration, confirming its safety and providing substantial clinical evidence for an immunoglobulin-G prescription.
The clinical results were published in the Annals of Clinical and Translational Neurology.
It is the first prospective clinical study in Korea and the second in the world to confirm the effectiveness of immunoglobulin-G in treating autoimmune encephalitis. Previous studies confirmed the reduction of seizure frequency with immunoglobulin-G administration but only in seropositive autoimmune encephalitis.
However, the prospective clinical result can be applied to both antibody-negative patients as well as seropositive autoimmune encephalitis.
"Through this prospective clinical trial, we have demonstrated the practical therapeutic effect of immunoglobulin-G therapy, which can be actively reflected in future treatment guidelines," said Professor Lee Soon-tae of Seoul National University Hospital.