La Jolla Pharmaceuticals (LJPC) - Get La Jolla Pharmaceutical Company Report said Monday that significantly more shock patients with critically low blood pressure responded to treatment with its experimental drug LJPC-501 compared to placebo, achieving the main goal of a phase III clinical trial.
The company intends to submit a marketing application for LJPC-501 to the U.S. Food and Drug Administration in the second half of the year, pending the outcome of a meeting with regulators to discuss the study results.
La Jolla's stock price rose 38% to $27.50 in Monday pre-marketing trading. The stock closed Friday at $19.87.
LJPC-501 is a proprietary formulation of a protein that helps to regulate blood pressure. The drug is being developed as a new treatment for patients in distributive shock, a life-threatening, low-blood pressure condition in which the heart is functioning normally but blood does not flow to vital organs.
In the phase III study, 70% of distributive shock patients treated with LJPC-501 on top of standard blood pressure medicines achieved a pre-specified target blood pressure increase compared to 23% of patients treated with a placebo plus standard of care. The benefit of LJPC-501 was statistically significant.
LJPC-501 did not help patients live longer than placebo by a statistically significant margin in the study, although prolonged survival did trend in the drug's direction with a 22% reduction in the risk of mortality.
La Jolla disclosed nothing in Monday's announcement about another important, secondary efficacy endpoint of the study -- a comparison between LJPC-501 and placebo in the ability to reduce organ failure.
On safety, 87% of LJPC-501 patients experienced at least one adverse event compared to 92% of placebo patients. More placebo patients dropped out of the study due to an adverse event compared to LJPC-501, the company said.
Prior to Monday's study results, Jefferies analyst Eun Yang forecast peak LJPC-501 sales of $260-520 million, which was depending on a wide range of pricing scenarios tied to the drug's overall benefit.
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