In the phase 3 trial dubbed ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) in 344 catecholamine resistant hypotension patients, LJPC-501 demonstrated positive top-line results.
The percentage of patients whose blood pressure response achieved a pre-specified target following treatment with LJPC-501 was statistically significant.
La Jolla Pharmaceutical president and CEO George Tidmarsh said: “We are grateful to the patients, their families and the dedicated medical teams who contributed to this successful study.
“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.”
As per the trial findings, 70% of the 163 patients who were treated with LJPC-501 achieved the desired results in comparison to the 23% of the 158 placebo-treated patients who achieved the pre-specified target blood pressure response.
Apart from that, LJPC-501 demonstrated a trend towards prolonged survival with mortality risk reduced to 22% till day 28. The phase 3 trial was observed by an independent Data Safety Monitoring Board (DSMB) which has recommended it to continue as originally planned.
In the severely ill patient group, 92% of patients treated with placebo against 87% of patients treated with LJPC-501 had at least one adverse event. The patient percentage which stopped treatment owing to an adverse event was 14% in the LJPC-501 group in comparison to 22% in the placebo group.
Michael Cudahy professor and Outcomes Research at Cleveland Clinic chair of the department Daniel Sessler said: “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.”
La Jolla is planning to submit the new drug application for LJPC-501 in the second half of this year.