Clinical Trial to Test Engineered Enzyme with Kidney Failure

Cross-section of kidney (National Library of Medicine)

AM-Pharma, a biopharmaceutical company in Bunnik, the Netherlands, began recruiting volunteers to test an engineered form of the human enzyme alkaline phosphatase to treat acute kidney injury. The clinical trial will test the safety and tolerability of the human recombinant alkaline phosphatase as well as its enzyme-chemical activity in blood serum, an indicator of treatment potential.

Acute kidney injury, also known as kidney failure, occurs when the kidneys stop their filtering function, allowing dangerous levels of wastes to build up in the blood. The disorder usually develops quickly, sometimes in a few hours, and most often affects people already hospitalized for other critical conditions.

The company says acute kidney injury acquired in health care facilities affects some 2 million patients a year in the U.S., Europe, and Japan, causing 700,000 deaths. There are currently no drugs to treat the condition, with care options targeting underlying causes of kidney failure, treatments for complications, and dialysis.

AM-Pharma is developing therapies based on the anti-inflammatory properties of alkaline phosphatase, which is found naturally in the internal membranes of the gastrointestinal tract, kidney, liver, and lungs. The enzyme has the ability to protect organs against inflammation and tissue damage, and at reduced levels is associated with acute kidney injury and ulcerative colitis, a type of inflammatory bowel disease.

The company tested the concept of treating patients with alkaline phosphatase in a form derived from cattle — bovine alkaline phosphatase. The clinical trial, held in 2008-2009, tested bovine alkaline phosphatase against a placebo with 36 sepsis patients suffering from acute kidney injury.

That trial measured levels of creatinine, a waste chemical generated by muscles that is usually cleared by healthy kidneys, as an indicator of the bovine alkaline phosphatase at work. The results showed those who took the bovine alkaline phosphatase had improved kidney functions compared to those receiving the placebo, in addition to the treatments being safe and well tolerated.

The new trial will test the human recombinant alkaline phosphatase with 50 healthy volunteers, verifying its safety and measuring the candidate therapeutic’s enzymatic activity. AM-Pharma plans to continue recruitment of test subjects into December 2013, results reported in 2014.

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