GCS-100 has the potential to treat various forms of chronic kidney disease characterized by tissue fibrosis by mediating the activity of galectin-3.
La Jolla is currently enrolling a phase 2 study of GCS-100 (GCS-100-CS-4002). This Phase 2 study is designed to enroll approximately 117 subjects, at least 18 years of age, with Stage 3b or 4 CKD. Subjects will be randomly assigned 1:1:1 to treatment with placebo, 1.5 mg/m2 GCS-100 or 30 mg/m2 GCS-100. In addition, randomization will be stratified into two groups according to baseline renal function as defined by eGFR values of 15-29 and 30-44 mL/min/1.73m2, respectively. Once randomized, subjects will receive eight consecutive weekly doses of their assigned treatment with a follow-up four weeks after treatment.
La Jolla has completed a phase 1/2 Study of GCS-100 in patients with stage 3B and stage 4 chronic kidney disease (GCS-100-CS-4001). Data from this study is summarized in a recent corporate presentation found here: Corporate Presentation July 9, 2013
To see our retrospective analysis of GCS-100 and its effect on eGFR Click Here
Chronic kidney disease currently affects 14% of Americans or approximately 49 million people. The United States Renal Data System, 2012 Annual Data Report, states that in 2010, costs for CKD reached $41 billion for Medicare alone. Overall per person per year costs for CKD were estimated at $22,323 for Medicare patients of age 65 and older and $13,395 for patients of age 50-64. Patients with CKD may progress to end-stage renal disease ("ESRD"). According to the National Institute of Diabetes and Digestive and Kidney Diseases as of 2008, there were 547,982 individuals in the US under treatment for ESRD and 88,630 deaths per year from ESRD.