Promising Phase 3 Study Results for Catecholamine Resistant Hypotension Mean Arterial Pressure
A positive phase 3 study showed that patients treated with LJPC-501 were likely to achieve pre-specified blood pressure targets vs placebo.
La Jolla announced positive data from the ATHOS-3 study which evaluated LJPC-501 (angiotensin II) for the treatment of catecholamine resistant hypotension (CRH), a life-threatening syndrome in patients with distributive shock who failed to achieve target mean arterial pressure (MAP) despite adequate fluid resuscitation and vasopressor use.
ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) was a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial evaluating LJPC-501 vs. placebo in 344 patients with CRH on a background of standard-of-care vasopressors. The primary efficacy endpoint was the percentage of patients with MAP ≥75mmHg or a 10mmHg increase from baseline MAP at 3 hours post treatment initiation without an increase in standard-of-care vasopressors. The study was conducted under a Special Protocol Assessment with the FDA, where both the agency and the company agreed on the study design, study endpoints and study analyses.
Analysis of the data showed that a significantly higher percentage of patients treated with LJPC-501 (70%) achieved the pre-specified target blood pressure response compared to placebo (23%) [P<0.00001]. Additionally, a trend toward longer survival was observed in LJPC-501-treated patients, with a 22% reduction in mortality risk through day 28 [HR=0.78 (0.57-1.07), P=0.12]. Safety outcomes were measured throughout the study which showed that 92% vs. 87% of patients treated with placebo and LJPC-501, respectively, experienced at least 1 adverse event. Detailed results of the ATHOS-3 study will be presented and submitted for publication later this year.
LJPC-501 is the first synthetic human angiotensin II drug candidate investigated in a Phase 3 study.
La Jolla Pharmaceutical Company announces positive top-line results from ATHOS-3 phase 3 study of LJPC-501 [news release]. San Diego, CA: La Jolla Pharmaceutical Company. Published February 27, 2017. Accessed March 1, 2017.