La Jolla finds potential jewel in successful Phase 3 trial

pharmafile | February 27, 2017 | News story | Manufacturing and Production, Research and Development La Jolla pharmaceutical 

La Jolla Pharmaceutical, a biotech company based in San Diego, US, received a boost to both its shares and its potential pipeline as it revealed it had met its primary endpoint in a Phase 3 trial. The trial was testing LJPC-501, a formulation of a natural peptide that regulates blood pressure.

The study found that the agent hit its primary endpoint of a specified target blood pressure response, with 70% of those treated hitting the response level and only 23% of those on placebo treatment managing the same. The results were enough to be deemed statistically significant.

In addition to reaching the primary endpoint, LJPC-501 also managed to exhibit a 22% drop in mortality, though this wasn’t at a level where it could be considered statistically significant.

LJPC-501 is aimed at those patients with distributive shock that had not responded to existing treatments. Distributive shock is a condition that sees the heart pumping at normal levels but without blood reaching vital organs correctly, with this resulting in catecholamine resistant hypotension.

“We are grateful to the patients, their families and the dedicated medical teams who contributed to this successful study,” said George F. Tidmarsh, 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.”

As mentioned by Tidmarsh, the results placed La Jolla in a good position to apply for an NDA later in the year. The results saw shares in La Jolla increase by 52% in price after the release of the news, even though data provided was only the top-line data – the full details of the trial are expected to be released in due course.

Ben Hargreaves

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