La Jolla Pharmaceutical Co. announced that it has administered the first dose for its Phase 1/2 clinical trial of GCS-100 in patients with chronic kidney disease. The study is an open-label, multi-center test of GCS-100 in patients with Stage 3b and 4 CKD.

The primary objectives of the study include evaluating the safety of a single dose (Part A) and repeat doses (Part B) of GCS-100. Secondary study objectives include evaluating galectin-3 serum levels, renal function and other markers of disease activity in CKD. The study is open to patients at least 18 years of age with moderately severe to severe renal impairment.

While not currently anticipated, the study design may be amended from time-to-time to comply with requests from the FDA, the governing Institutional Review Board, study investigators or at the discretion of the company. GCS-100 is a complex polysaccharide that has the ability to bind to and block the effects of galectin-3. Galectin-3 is a soluble protein, over-expression of which has been implicated in a number of human diseases including cancer and chronic organ failure. The unique ability of GCS-100 to bind and sequester galectin-3 makes it an ideal candidate to prevent and treat diseases in which galectin-3 plays an important role.