La Jolla Pharmaceutical obtained an exclusive worldwide license to George Washington (GW) University’s intellectual property rights related to the use of angiotensin II to treat patients with hypotension and shock. A Phase III registration program of LJPC-501, La Jolla’s formulation of angiotensin II, in catecholamine-resistant hypotension (CRH) is expected to launch early next year.
Angiotensin II, the major bioactive product of the renin-angiotensin system, serves as one of the body’s central regulators of blood pressure. La Jolla is developing LJPC-501 for the treatment of catecholamine-resistant hypotension, or CRH, which is an acute, life-threatening condition in which blood pressure drops to dangerously low levels. Angiotensin II has been shown to raise blood pressure in a randomized, placebo-controlled clinical trial in CRH, as well as animal models of hypotension.
This is an expansion of an existing deal. La Jolla signed an option agreement in February that initiated this relationship.
“We are very pleased to gain access to this additional intellectual property covering LJPC-501,” said George F. Tidmarsh, M.D., Ph.D., president and CEO of La Jolla. “The prognosis for patients suffering from CRH is very poor, with less than 50% 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.”
In July, La Jolla submitted an Orphan Drug Designation application to FDA for LJPC-501 in the treatment of CRH. The California-based pharma is also developing LJPC-501 for hepatorenal syndrome (HRS), a form of progressive renal failure in patients with liver cirrhosis or fulminant liver failure. It is currently conducting a Phase I/II clinical trial.