La Jolla, George Washington University Partner On Angiotensin II For Hypotension, Shock
By Cyndi Root
La Jolla Pharmaceutical Company and George Washington University (GW) have partnered to develop La Jolla’s angiotensin II products. La Jolla announced the deal in a press release, stating that it is starting a Phase 3 program in the first quarter of 2015 for its angiotension agent (LJPC-501) in catecholamine-resistant hypotension (CRH). The deal covers GW’s intellectual property (IP) on angiotension II. George F. Tidmarsh, M.D., Ph.D., 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, provide a significant benefit to these patients.”
La Jolla and GW Agreement
Steven Kubisen, Director of the GW Office of Technology Transfer, stated that La Jolla’s expertise with LJPC-501 bodes well for the new partnership. The new deal makes it possible to take GW’s discoveries out of the lab and into a Phase 3 trial. La Jolla and GW did not disclose further details about the partnership or offer financial details.
LJPC-501
LJPC-501 is a proprietary formulation of angiotensin II, a regulator of blood pressure. La Jolla developed LJPC-501 for catecholamine-resistant hypotension, a life-threatening drop in blood pressure. In animal models of hypotension and in placebo-controlled trials, angiotensin II demonstrated blood pressure-raising abilities. The Food and Drug Administration (FDA) agreed to make improved blood pressure the primary endpoint for approval in the CRH indication. La Jolla intends to proceed with this trial in the first quarter of 2015. The company has also submitted an Orphan Drug application to the FDA for the treatment of CRH.
In addition to developing LJPC-501 for CRH, La Jolla is also investigating the agent in hepatorenal syndrome (HRS). This condition features progressive renal failure in patients with liver cirrhosis or fulminant liver failure. The diseased liver secretes nitric oxide and prostaglandins into the bloodstream, causing under-filling of blood vessels and a reduction in kidney blood flow. La Jolla is running Phase 1/2 studies of LJPC-501 in HRS and enrolled the first patient in August 2014.