La Jolla Pharmaceutical Company has enrolled its first patient on its Phase I/II clinical trial of LJPC-501, a proprietary formulation of angiotensin II, to treat type 1 and type 2 hepatorenal syndrome (HRS).
HRS is a life-threatening form of progressive renal failure in people with liver cirrhosis or fulminant liver failure.
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Around 15 patients with type 1 or type 2 HRS are expected to be enrolled in the open-label, multi-centre clinical trial.
LJPC-501 is a peptide agonist of the renin-angiotensin system that acts to stabilise blood pressure.
La Jolla president and chief executive officer George Tidmarsh said: "We believe that LJPC-501, which helps the kidneys balance body fluids and electrolytes, may improve kidney function in patients with HRS.
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"For many patients with HRS, reduced kidney function is the major debilitating aspect of their illness."
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By GlobalDataSafety and tolerability are the primary endpoints of the trial, while secondary endpoints include determining the maximum tolerated dose and the effects of LJPC-501 on serum creatinine through five days of treatment.
During the trial, patients will be given LJPC-501 at titrated doses, with a starting range of one to 100ng/kg/min by continuous infusion on days one through five.
Dose titrations will occur every four hours until a mean arterial pressure of 110mmHg is reached and a maximum urine output is achieved, or a dose of 100ng/kg/min is achieved.
The company said that dosing will then continue at this maximum dose through day five.
LJPC-501 is being developed by the company to treat catecholamine-resistant hypotension (CRH), an acute, life-threatening condition in which blood pressure drops to dangerously low levels and is poorly responsive to current treatments.
In a randomised, placebo-controlled clinical trial, LJPC-501 has been shown to increase blood pressure and animal models of hypotension.
At a recent meeting with the US Food and Drug Administration (FDA), the company entered into an agreement that blood pressure could serve as an appropriate primary endpoint for approval.
After securing the FDA approval, the company intends to start a Phase III registration programme with LJPC-501 in the treatment of CRH.
The company has also filed an application to the FDA seeking orphan drug designation for LJPC-501, due to the estimated size of the patient population in the US for this indication.
Image: High magnification micrograph of a liver with cirrhosis. Photo: courtesy of Nephron.
