La Jolla Pharmaceutical Co., a developer of therapeutics that target galectin-3, announced that the FDA Division of Cardiovascular and Renal Products approved the company's investigational new drug application (IND) for GCS-100.
La Jolla will start a Phase 1/2 clinical trial of GCS-100 in patients with chronic kidney disease (CKD). Chronic kidney disease currently affects 14 percent of Americans, or approximately 49 million people in the U.S.
The study will be an open-label, multicenter test of weekly doses of GCS-100 in patients with Stage 3b and 4 CKD. The primary objectives of the study include evaluations of the safety of a single dose of GCS-100 (Part A) and repeat doses of GCS-100 (Part B). Secondary study objectives will include evaluating renal function and other markers of activity in CKD.
The study will be open to patients at least 18 years of age with moderately severe to severe renal impairment. The company anticipates screening of patients will start this month and the first patient will enter the study in January of next year. The trial will be conducted at centers in the United States and include some of the top investigators in the field of CKD. While it is 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.