La Jolla Pharmaceutical Company Announces Initiation of Phase 3 Clinical Trial of LJPC-501 in Catecholamine-Resistant Hypotension

La Jolla Pharmaceutical Company

(the Company or La Jolla), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced that it has initiated its ATHOS (Angiotensin II for the Treatment of High-Output Shock) 3 trial, a Phase 3 clinical trial of LJPC-501 for the treatment of catecholamine-resistant hypotension (CRH). In February 2015, La Jolla reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA), in which it was agreed that the primary efficacy endpoint for the trial would be increase in blood pressure. CRH is an acute, life-threatening condition in which blood pressure drops to dangerously low levels in patients who respond poorly to current treatments. In accordance with the SPA, the ATHOS 3 trial is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical trial of LJPC-501 in patients with CRH. The ATHOS 3 trial is designed to enroll approximately 315 patients. Patients will be randomized 1:1 to receive either LJPC-501 plus standard-of-care vasopressors or placebo plus standard-of-care vasopressors. Randomized patients will receive their assigned treatment via continuous IV infusion for up to 7 days. The primary efficacy endpoint of the ATHOS 3 trial is to compare the change in mean arterial pressure between the two groups in the trial. Secondary endpoints include comparison of changes in Sequential Organ Failure Assessment scores and the safety and tolerability of LJPC-501 in patients with CRH. La Jolla has reached agreement with the FDA that an adequately sized Phase 3 trial comprised of 200-300 patients would provide a sufficient safety database to support FDA review and consideration for marketing approval. "The prognosis for patients suffering from CRH is very poor, and current treatment options are limited. We believe that LJPC-501 has the potential to reverse hypotension and, therefore, provide a significant benefit to these difficult-to-treat patients," said Lakhmir Chawla, M.D., Associate Professor of Medicine, Department of Anesthesiology and Critical Care Medicine, George Washington University. "We are pleased to have advanced LJPC-501 into a Phase 3 registration clinical trial," said George F. Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. "We would like to thank the FDA and our clinical collaborators for helping us to advance this medically important program so expeditiously."