LJPC-501 is La Jolla’s proprietary formulation of angiotensin II. Angiotensin II, the major bioactive component of the renin-angiotensin system, serves as one of the body’s central regulators of blood pressure.
LJPC-501 for Catecholamine-Resistant Hypotension (CRH)
La Jolla is developing LJPC-501 for the treatment of catecholamine-resistant hypotension (CRH), which is an acute, life-threatening condition in which blood pressure drops to dangerously low levels in patients who respond poorly to current treatments. Angiotensin II has been shown to raise blood pressure in a randomized, placebo-controlled clinical trial in CRH, which was recently published in the journal Critical Care, as well as in animal models of hypotension. Preclinical pharmacology studies conducted by La Jolla have demonstrated that catecholamine resistance may be in part a result of reduced endogenous production of angiotensin II. La Jolla is currently enrolling patients into its ATHOS (Angiotensin II for the Treatment of High-Output Shock) 3 trial, which is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical trial of LJPC-501 in patients with CRH. The ATHOS 3 trial is being conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration in which it was agreed that the primary efficacy endpoint is increase in blood pressure. Results from ATHOS 3 are expected by the end of 2016.