La Jolla reports organ failure data in Phase III ATHOS-3 trial

La Jolla Pharmaceutical Co. (NASDAQ:LJPC) reported additional data from the Phase III ATHOS-3 trial to treat catecholamine-resistant hypotension showing that continuous treatment with dose-titrated IV LJPC-501 for up to 7 days met 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). LJPC-501 missed the secondary endpoint of improving SOFA total score vs. placebo (p=0.49). The double-blind, international trial enrolled 321 evaluable critically ill patients with catecholamine-resistant hypotension on a background of standard of care (SOC) vasopressors. Data were published in the New England Journal of Medicine.

Doctors interviewed by BioCentury earlier this year said they saw little reason to use LJPC-501 to treat distributive shock unless it can significantly reduce organ failure and/or mortality. In distributive shock, blood pressure plummets despite adequate cardiac function...