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La Jolla plans filing on back of blood pressure trial data

Almost three-quarters of CRH patients met threshold for blood pressure response

La JollaUS biotech La Jolla Pharmaceutical added 76% to the value of its shares yesterday after it reported data from a phase III trial showing its drug for low blood pressure.

The ATHOS-3 study found that LJPC-501, a synthetic formulation of natural peptide called angiotensin II that regulates blood pressure, hit its primary endpoint of raising blood pressure in patients with catecholamine-resistant hypotension (CRH), setting up a regulatory filing later this year.

CRH is a life-threatening syndrome resulting from an underlying cause such as septic shock, trauma, or severe drug reactions, which can cause a phenomenon known as distributive shock. Approximately, 6-7% of patients will require excessive doses of vasopressors and are considered resistant to treatment.

All told, 70% of the LJPC-501-treated group in ATHOS-23 met the threshold for a clinically-relevant blood pressure response, compared to only 23% of those on placebo. La Jolla also pointed to a trend towards improved survival, with a 22% reduction in mortality risk through day 28 with the active drug, although it stressed this was not statistically significant.

All patients in the trial were given standard background treatment for hypotension using vasopressor drugs (catecholamine drugs such as epinephrine and/or vasopressin).

La Jolla estimates that there are around half a million distributive shock cases in the US each year, with 200,000 patients going on to develop CRH. More than 50% of CRH patients die within 30 days, it says.

That adds up to a sizeable target population for LJPC-501 if approved, and Cowen analyst Phil Nadeau reckons the drug could achieve sales of $280m in 2021 "driving La Jolla to profitability”.

"These study results support that angiotensin II … improves outcomes in distributive shock patients requiring high-dose catecholamines," said Daniel Sessler, chair of the Department of Outcomes Research at Cleveland Clinic where angiotensin II was first synthesized.

"Given the high mortality from this condition, it is important to offer physicians another potential treatment option,” he added.

Article by
Phil Taylor

28th February 2017

From: Research



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