La Jolla Blood Pressure Drug Did Well In Study (LJPC)
- Author: Zachary Reyes Фев 27, 2017,
Фев 27, 2017, 22:10
The company says it will present and publish more detailed results from the trial later this year. This trial was created to test the company's lead compound - LJPC-501 - as a potential treatment for catecholamine-resistant hypotension, or CRH.
The primary efficacy result was statistically significant: 70% of 163 patients treated with LJPC-501 showed a blood pressure response compared with 23% of 158 placebo-treated patients (P 0.00001). La Jolla developed its drug to treat patients who don't respond to blood pressure regulating drugs now administered in the standard of care.
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 p-value of the data was less than 0.00001, which was strong enough to demonstrate statistical significance.
The company said the study data also showed a trend towards longer survival in patients treated with LJPC-501. (LJPC) said its LJPC-501 (angiotensin II) drug for treating low blood pressure achieved the primary objective in a late-stage study.
La Jolla's stock jumped 51 percent to $29.99 in low volumes in premarket trading.
Around half a million distributive shock cases are reported in the United States each year, of which around 200,000 develop CRH. "We also are very appreciative of the FDA's advice and contributions in the development of LJPC-501 and look forward to meeting with the FDA to discuss our NDA submission planned for the second half of this year". That's one reason that the mortality rate of this condition exceeds 50%, which is telling about the huge unmet medical need for new treatment options.
The company plans to submit a marketing application in the U.S.in H2.
However, it is worth noting that the company's press release did not mention any information about ATHOS-3's secondary endpoint, which was to compare LJPC-501 ability to reduce organ failure to placebo. If all goes well, then LJPC-501 could be on the market by 2018.