La Jolla Completes Dosing Of Phase 2 Trial Of GCS-100 For Chronic Kidney Disease

(RTTNews) - La Jolla Pharmaceutical Co. (LJPC) reported the completion of dosing of its Phase 2 trial of GCS-100 for chronic kidney disease treatment and has collected the final data for evaluation of the primary endpoint.

The primary efficacy endpoint is the change in estimated glomerular filtration rate or eGFR from baseline to the average at Day 50 and 57 in each GCS-100 dose group compared to placebo. This would be reached provided the difference in eGFR between either GCS-100 dose group and placebo has a significance of less than 10%, the company said.

The company is looking forward to analyze the data, which it expects to release in March. Of the 121 subjects with Stage 3b or 4 CKD enrolled, 117 subjects completed the study with no discontinuation due to an adverse event.

GCS-100, the company's lead product candidate, is a modified pectin and is now being tested in a Phase 2 study and extension study in patients with chronic kidney disease.