La Jolla Pharmaceutical Company (NASDAQ: LJPC) (the "Company" or "La Jolla"), a biotechnology company developing therapeutics targeting significant unmet, life-threatening diseases today announced that it has completed dosing of its Phase 2 clinical trial of GCS-100 for the treatment of chronic kidney disease ("CKD") and has collected the final data for evaluation of the primary endpoint. The primary efficacy endpoint is the change in estimated glomerular filtration rate ("eGFR") from baseline to the average at Day 50 and 57 in each GCS-100 dose group compared to placebo. The primary endpoint will be reached if the difference in eGFR between either GCS-100 dose group and placebo has a significance of less than 10% (p-value of <0.1).
The protocol for the Phase 2 study (GCS-100-CS-4002) and the ongoing Phase 2 extension study (GCS-100-CS-4003) have been posted on the company's website www.ljpc.com.
"We are pleased to have completed the Phase 2 study dosing and want to thank the patients and investigators who participated," said George Tidmarsh, MD, PhD, President and CEO at La Jolla. "We look forward to analyzing the data which we expect 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. Subjects were randomly assigned 1:1:1 to treatment with placebo, 1.5 or 30 mg/m2 of GCS-100. In addition, randomization was stratified by baseline renal function, defined by eGFR values of 15-29 and 30-44 mL/min/1.73m2. Once randomized, subjects received eight consecutive weekly doses of their assigned treatment with a follow-up four weeks after treatment.
La Jolla Pharmaceutical Company