La Jolla reports additional Phase III data for LJPC-501 in catecholamine-resistant hypotension

In September, La Jolla Pharmaceutical Co. (NASDAQ:LJPC) reported additional data from the Phase III ATHOS-3 trial of LJPC-501 (angiotensin II) to treat hypotension in adults with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy. The data showed that continuous treatment with dose-titrated IV LJPC-501 for up to 7 days reduced the risk of mortality by 36% vs. placebo (HR=0.64, 95% CI: 0.41, 1, p=0.047). Data were presented at the European Society of Intensive Care Medicine meeting in Vienna.

Earlier this year, La Jolla reported that LJPC-501 met ATHOS-3's primary endpoint of improving the rate of blood pressure response vs. placebo (69.9% vs. 23.4%, p<0.00001) and the secondary endpoint of improving Sequential Organ Failure Assessment (SOFA) cardiovascular scores from baseline to 48 hours vs. placebo (1.75 vs. 1.28 points, p=0.01) (see BioCentury, March 2 & May 26). The double-blind, international trial enrolled 321 evaluable critically ill patients with catecholamine-resistant hypotension on a background of standard of care (SOC) vasopressors...