|GC Pharma's headquarters building in Yongin, Gyeonggi Province (GC Pharma)|
GC Pharma on Thursday reported positive top-line results from the phase 3 clinical trial of its immunoglobulin product GC5107.
The clinical study results have been published in the peer-reviewed journal Frontiers in Immunology, the company said.
The phase 3 study was conducted on 49 patients who were diagnosed with primary immunodeficiency. The patients aged between 3-70 received infusions of GC5107 doses every 21 or 28 days for 12 months at 17 medical institutions in the US and Canada.
The study results showed GC5107 met the US Food and Drug Administration’s efficacy and safety requirements, GC Pharma said.
Only one acute bacterial infection occurred among the patients during the one-year study, resulting in a significantly lower incidence rate compared with the efficacy requirement suggested by the US FDA.
The proportion of patients who showed temporally associated adverse events within 72 hours after GC5107 infusion was 24 percent, also lower than the FDA safety requirement of 40 percent, according to GC Pharma.
Based on the clinical trial results, GC Pharma submitted a Biologics License Application to the US FDA in February. The FDA will review the application and aim to finish the evaluation by February next year.