The ALYGLO pivotal phase 3 clinical study followed FDA guidance for the treatment of patients with PI. The clinical trial (NCT02783482) GC5107B was a prospective, open-label, single-arm, historically controlled, multicenter phase 3 study to assess the efficacy and safety of GC5107B in patients with a confirmed diagnosis of PI. The studies were conducted in the United States and Canada. Key findings from the phase 3 clinical trial for patients aged 17 years and older include the following:

1. A primary efficacy end point of 0.03 acute serious bacterial infections (aSBIs) per patient-year, which met the FDA efficacy requirement of less than one aSBI per patient-year.
2. The proportion of infusions with temporally associated adverse events occurring during or within 72 hours after infusion was 0.22 (95% one-sided upper confidence bound: 30%), which met the FDA-required prespecified end point of less than 0.40.
3. Secondary analyses were annual rate or days of other infections, antibiotic use, days out of work/school/day care or unable to perform normal activities due to infection, and days of hospitalization due to infection.

­­The results of the phase 3 trial by GC Biopharma are published in Frontiers in Immunology (2021).  Dr. Elena Perez, MD., Allergy Immunologist from Allergy Associates of the Palm Beaches, and lead study investigator, said, "Alyglo will significantly impact clinical practice in the U.S. due to its strong safety and efficacy profile.  It is an important treatment option for primary immune-deficient patients. This product provides additional confidence in treatment options for this important patient population."

In addition, ALYGLO uses its novel Cation Exchange Chromatography (CEX) in the manufacturing process for removing coagulation factor XIa (FXIa) to undetectable levels. The presence of residual activated FXIa in some commercial IGIV products has been identified as the root cause of a small number of thromboembolic events in patients receiving immunoglobulin infusions. A recent study published in Frontiers in Cardiovascular Medicine details the extensive testing of ALYGLO and its results of the GC Biopharma manufacturing process. GC Biopharma is committed to evaluating how this new manufacturing process serves to further improve product safety.

Dr. Eun-chul Huh, President and CEO of GC Biopharma, said, "The approval of ALYGLO by the US FDA is a significant milestone for GC Biopharma and patients with primary immunodeficiency disease. It reinforces GC Biopharma's commitment to patients and health care professionals by expanding our product portfolio globally to serve individuals with rare diseases. We are pleased to offer patients another important treatment option in the coming months that is both safe and effective."