La Jolla Licenses LJPC-501 To Washington University
La Jolla Pharmaceuticals announced that it has entered into an exclusive global license agreement with the George Washington University concerning intellectual property rights of its drug LJPC-501 as a treatment for hypotension and shock.
LJPC-501 is the company’s proprietary formulation of angiotensin II in development as treatment of catecholamine-resistant hypotension (CRH). CRH is an acute, deadly condition wherein blood pressure can plunge to low levels and become life threatening. The drug is a peptide agonist of the rennin-angiotensin system designed to stabilize blood pressure. Placebo-controlled clinical trials of LJPC-501 show that the drug was able to raise blood pressure in CRH, as well as animal models of hypotension. The company has filed for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) for LJPC-501 in CRH. A Phase 1/2 trial of LJPC-501 as treatment for type 1 and type 2 hepatorenal syndrome (HRS) is currently ongoing.
Dr. George F. Tidmarsh, President and CEO of La Jolla, said, “We are very pleased to gain access to this additional intellectual property covering LJPC-501. The prognosis for patients suffering from CRH is very poor, with less than 50 percent of these patients surviving one month from diagnosis. We believe that LJPC-501 has the potential to reverse hypotension and, therefore, can provide a significant benefit to these patients.”
La Jolla said it plans to launch a Phase 3 trial of LJPC-501 in the first quarter of 2015. Based on a meeting the company had with the FDA, La Jolla said the trial’s primary endpoint for approval will be measure of blood pressure in CRH.
“Moving this important innovation from GW's School of Medicine directly to a Phase 3 clinical trial means that doctors treating hypotension and shock could have better options relatively soon. La Jolla's expertise with LJPC-501 makes this partnership well-positioned for success,” said Steven Kubisen, Director of the GW Office of Technology Transfer.