La Jolla Pharmaceutical Completes Dosing In Trial For Chronic Kidney Disease
By Cyndi Root
La Jolla Pharmaceutical Company announced in a press release that dosing is complete in a clinical trial of GCS-100 for chronic kidney disease. Investigators are analyzing the data for meeting the primary endpoint of a change in estimated glomerular filtration rate (eGFR). George Tidmarsh, MD, PhD, President and CEO at La Jolla, said, “We are pleased to have completed the Phase 2 study dosing and want to thank the patients and investigators who participated. We look forward to analyzing the data which we expect to release in March.”
Chronic Kidney Disease
Chronic kidney disease (CKD) is caused by high blood pressure or diabetes in two thirds of cases. These conditions and others hamper the kidneys’ ability to filter waste. When the waste product builds to unhealthy levels, patients feel ill and suffer from anemia, high blood pressure, nerve damage, and weak bones. Additionally, nutritional deficits cause further stress. With early treatment, patients can slow the progression. Untreated, people may need dialysis or a kidney transplant. An estimated 26 million people have CKD.
GCS-100
GCS-100 is a pectin, a high molecular weight polysaccharide. Pectins have natural sources like apples. GCS-100 is a modified pectin that binds to galectin-3 and blocks its effects. In diseases where galectin-3 figures prominently, GCS-100 has a unique ability to alter the outcome. Due to its high molecular weight, it stays in the appropriate domain for a considerable time, extending its galectin-3 binding ability.
GCS-100 Phase 2 Study
117 patients of the 121 enrolled in the study finished the assigned dosing. These patients with Stage 3b or 4 CKD either took a placebo or 1.5 or 30 mg/m2 of GCS-100. Investigators will consider the primary endpoint as met if the difference in eGFR between the groups is less than 10% (p-value of <0.1).
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company focuses on organ failure and cancer. The company discovers, develops, and markets therapeutics. GCS-100 is the leading drug in the pipeline. LJPC-501 is an agent for hepatorenal syndrome and LJPC-401 is a treatment for iron overload. The Food and Drug Administration (FDA) has granted La Jolla’s Investigational New Drug (IND) for LJPC-501 and a Phase I trial is underway.