La Jolla Pharmaceutical Co. (NASDAQ: LJPC) saw its shares skyrocket on Monday after top-line results from its late-stage study of LJPC-501 in patients with catecholamine resistant hypotension. Ultimately, LJPC-501 posted a statistically significant response to the trial that met the primary endpoint.
Excluding Monday’s move, the stock was up 13% year to date. Over the past 52 weeks, it is actually up 29%. The stock hit a multiyear high not seen since 2015.
Specifically, the analysis of the primary efficacy endpoint 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. In addition, a trend toward longer survival was observed: 22% reduction in mortality risk through day 28 for LJPC-501-treated patients.
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 this critically ill patient population, 92% of placebo-treated patients compared to 87% of LJPC-501-treated patients experienced at least one adverse event, and 22% of placebo-treated patients compared to 14% of LJPC-501-treated patients discontinued treatment due to an adverse event.
Daniel Sessler, M.D., the Michael Cudahy Professor and Chair of the Department of Outcomes Research at Cleveland Clinic, commented:
These study results support that angiotensin II, a molecule first synthesized by Dr. Irvine Page at the Cleveland Clinic, improves outcomes in distributive shock patients requiring high-dose catecholamines. Given the high mortality from this condition, it is important to offer physicians another potential treatment option.
In collaboration with the investigators, La Jolla plans to present and publish detailed results from the ATHOS-3 study later this year.
George F. Tidmarsh, M.D., Ph.D., president and CEO of La Jolla, finished the report by saying:
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.
Shares of La Jolla were last seen up 73% at $34.48 on Monday, with a consensus analyst price target of $45.50 and a 52-week trading range of $14.24 to $36.00.