La Jolla Pharmaceutical Company (Nasdaq: LJPC) (La Jolla), today announced positive top-line results from the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) Phase 3 study of LJPC-501 (angiotensin II) in patients with catecholamine resistant hypotension (CRH).
The analysis of the primary efficacy endpoint, defined as 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 (p<0.00001). In addition, a trend toward longer survival was observed: 22% reduction in mortality risk through day 28 [hazard ratio=0.78 (0.57-1.07), p=0.12] 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. In collaboration with the investigators, La Jolla plans to present and publish detailed results from the ATHOS-3 study later this year.
ATHOS-3 was conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA), in which the company and FDA agreed on the study design, study endpoints and study analyses.
“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,” said Daniel Sessler, M.D., the Michael Cudahy Professor and Chair of the Department of Outcomes Research at Cleveland Clinic.
“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.”
Filed Under: Drug Discovery