GC Publishes the Results of GC5107 in P-III Trial for the Treatment of Primary Immunodeficiency in Frontiers in Immunology

August 12, 2021 Auto Bot Clinical Trials 0

Shots:

  • The P-III trial evaluates the efficacy and safety of GC5107 (IV, every 21 or 28 days for 12 mos.) in 49 patients aged 3-70yrs. with PI. The trial was conducted at 17 study sites (10 in the US & 7 in Canada)
  • The trial met its1EP & 2EPs i.e., <1 aSBI occurred among the patients during 1yr., <40% showed temporally associated AEs within 72hrs. after infusion, >98% of the infusions were completed without discontinuation. GC5107 (10% IgG formulation) is safe, effective, and well-tolerated in adolescent and adult patients
  • In Feb’21, the company had submitted a BLA to the US FDA based on the clinical trial results. The anticipated PDUFA date for FDA’s decision on the application is Feb’22

Click here to­ read full press release/ article | Ref: Businesswire | Image: Linkedin

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