La Jolla Pharmaceutical Co. (LJPC) said its LJPC-501 (angiotensin II) drug for treating low blood pressure achieved the primary objective in a late-stage study. (See also, Capricor Ends Cenderitide Heart Drug Program.)
Following the news, La Jolla Pharmaceutical's stock price spiked 81%, trading at $36.15 per share, up $16.28, on Monday afternoon. (See also, Boston Scientific Recalls Lotus Heart Devices.)
In the placebo-compared Phase 3 study of LJPC-501, the drug demonstrated a statistically significant improvement in increasing blood pressure than a placebo in treating patients with catecholamine resistant hypotension (CRH). A placebo is a substance that has no therapeutic effect, and is used as a control in testing new drugs.
The study results showed that 70% of the 163 LJPC-501-treated patients had a blood pressure response, compared to 23% of the 158 placebo-treated patients. The drug also resulted in a 22% decrease in mortality risk through day 28.
Catecholamine resistant hypotension (CRH) is a life-threatening disorder of abnormally low blood pressure in patients with distributive shock, a state in which the heart performs its blood pumping function properly but the blood distribution remains problematic leading to dangerously low blood pressure condition.
LJPC-501 is intended as a treatment for such CRH patients with distributive shock who have not adequately responded to existing treatments like vasopressors, a drug or other agent which causes the constriction of blood vessels. The drug works by serving as one of the body’s central regulators of blood pressure, and is the first synthetic human angiotensin II product candidate to be tested in a Phase 3 study.
Around half a million distributive shock cases are reported in the United States each year, of which around 200,000 develop CRH. Around half of the CRH patients die within 30 days due to the devastating nature of the disease, and the average cost of each patient comes to $100,000.