Blog Coverage La Jolla's Lead Product Candidate LJPC-501 Posts Positive Phase-III Trial Results
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LONDON, UK / ACCESSWIRE / February 28, 2017 / Active Wall St. blog coverage looks at the headline from La Jolla Pharmaceutical Co. (NASDAQ: LJPC) as the Company announced on February 27, 2017, positive results from the Phase-3 study of LJPC-501 in patients with catecholamine resistant hypotension (CRH). Register with us now for your free membership and blog access at:
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One of La Jolla Pharma's competitors within the Biotechnology space, Sage Therapeutics, Inc. (NASDAQ: SAGE), reported on February 23, 2017, its business highlights and financial results for Q4 and full year ended December 31, 2016. AWS will be initiating a research report on Sage Therapeutics in the coming days.
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ATHOS-3 Study
The ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) trial was designed as a multicenter, randomized, double-blind, placebo-controlled, Phase-3 clinical study to test La Jolla's lead product LJPC-501 in patients with CRH. A total of 344 patients were randomized across nine countries, 321 of whom received study treatment. Patients were randomized 1:1 to receive either LJPC-501 or placebo on a background of standard-of-care vasopressors selected by the investigators. Randomized patients received their assigned treatment via continuous intravenous infusion.
The primary efficacy endpoint was the percentage of patients with a mean arterial pressure (MAP) ≥ 75 mmHg or a 10 mmHg increase from baseline MAP at 3 hours following the initiation of study treatment without an increase in standard-of-care vasopressors. ATHOS-3 was conducted under a Special Protocol Assessment (SPA) agreed with the US Food and Drug Administration (FDA) in 2015. The SPA stipulates that a study of this size and design could provide sufficient safety and efficacy signals and an adequate evaluation of the risk/benefit to the patients to support FDA review and consideration for marketing approval.
Data from the ATHOS- 3 study demonstrated that the percentage of patients achieving a pre-specified target blood pressure response was highly statistically significant: 23% of the 158 placebo-treated patients had a blood pressure response compared to 70% of the 163 LJPC-501-treated patients. On the downside, LJPC-501 treated patients showed a 22% reduction in mortality risk through day 28.
Throughout the study, safety outcomes were followed by an independent Data Safety Monitoring Board (DSMB). The DSMB recommended that the study continue as originally planned. In collaboration with the investigators, La Jolla plans to present and publish detailed results from the ATHOS-3 study later this year.
"We are grateful to the patients, their families, and the dedicated medical teams who contributed to this successful study," said George F. Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla, "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."
About LJPC-501
LJPC-501 is La Jolla's proprietary formulation of synthetic human angiotensin II. Angiotensin II, the major bioactive component of the renin-angiotensin system, serves as one of the body's central regulators of blood pressure. LJPC-501 is being developed for the treatment of patients with catecholamine resistant hypotension (CRH). LJPC-501 is the first synthetic human angiotensin II product candidate to be tested in a Phase-3 study.
What is Catecholamine Resistant Hypotension?
CRH is a life-threatening condition in patients with distributive shock (dangerously low blood pressure with adequate cardiac function) in which blood does not properly flow to vital organs. As per the press release, there are approximately 500,000 distributive shock cases in the United States per year, an estimated 200,000 of which develop CRH. More than 50% of CRH patients die within 30 days.
Stock Performance
At the closing bell, on Monday, February 27, 2017, following the announcement, La Jolla Pharma's stock skyrocketed 76.75%, ending the trading session at $35.12. A total volume of 18.28 million shares were traded at the end of the day, which was higher than the 3-month average volume of 146.21 thousand shares. In the last six months and previous twelve months, shares of the Company have rallied 106.10% and 121.30%, respectively. Moreover, the stock soared 100.34% since the start of the year. The stock currently has a market cap of $604.45 million.
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