SAN DIEGO, CA--(Marketwired - December 16, 2013) - La Jolla Pharmaceutical Company (OTCBB: LJPC) (the "Company" or "La Jolla"), a leader in the development of therapeutics targeting significant unmet life-threatening diseases, today announced that it has completed enrollment of its placebo-controlled, randomized Phase 2 clinical trial of GCS-100 in patients with chronic kidney disease ("CKD"). A total of 121 patients with Stage 3b or 4 CKD were enrolled in the study. The Company expects to announce data on the primary endpoint in April 2014 and the full data package before the end of the second quarter 2014.
"We would like to gratefully thank the patients and Investigators for their participation in our Phase 2 study, and we look forward to analyzing the data," said George F. Tidmarsh, M.D., Ph.D., President and CEO of La Jolla. "We plan to make all data available to the public as soon as possible."
This Phase 2 study was designed to enroll approximately 117 subjects, at least 18 years of age, with Stage 3b or 4 CKD. 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 receive eight consecutive weekly doses of their assigned treatment with a follow-up four weeks after treatment.
The primary objective of this study is to compare the change in eGFR from baseline to the end of treatment between placebo and GCS-100 treatment. The secondary objective is to determine the safety and tolerability of GCS-100 administered for 8 weeks relative to placebo. In addition, the study measures the effect of GCS-100 on circulating galectin-3 and other markers of disease activity.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapeutics for chronic organ failure and cancer. GCS-100, the Company's lead product candidate, is a first-in-class inhibitor of galectin-3, a novel molecular target implicated in chronic organ failure and cancer. LJPC-501, the Company's second product candidate, is a natural peptide for the treatment of hepatorenal syndrome. For more information on the Company please visit http://www.ljpc.com.
Forward Looking Statement Safe Harbor
This document contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to future events or our future results of operations. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause actual results to be materially different from these forward-looking statements. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties, and other factors are described in greater detail in the Company's filings with the U.S. Securities and Exchange Commission ("SEC"), all of which are available free of charge on the SEC's web site http://www.sec.gov. These risks include, but are not limited to, risks relating to the development of GCS-100 and LJPC-501, the success and timing of future preclinical and clinical studies of these compounds, and potential indications for which GCS-100 and LJPC-501 may be developed. Subsequent written and oral forward-looking statements attributable to the Company or to persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth in the Company's reports filed with the SEC. The Company expressly disclaims any intent to update any forward-looking statements.