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Trial Underway Testing Flesh-Eating Bacteria Drug

Streptococcus pyogenes bacteria

Streptococcus pyogenes bacteria (Centers for Disease Control and Prevention)

7 December 2015. A late-stage clinical trial began enrolling patients to test a new treatment for rare, but dangerous bacterial infections that destroy soft tissue and muscle. The trial is testing AB103, a biologic therapy developed by the biotechnology company Atox Bio in Ness Ziona, Israel.

AB103 is designed to treat necrotizing soft tissue infections, rare but severe infections from bacteria that release toxins destroying the skin and soft connecting tissue under the skin, including muscle. These infections can start with small cuts or scrapes that allow Streptococcus pyogenes and other types of bacteria to enter. The bacteria, also known as flesh-eating bacteria, colonize and grow, releasing their toxins that kill tissue cells and enter the blood stream, allowing toxins to spread through the body.

While the necrotizing soft tissue infections are rare — the company says between 25,000 and 29,000 cases are reported annually in the U.S. — the disease leads to death in 15 to 20 percent of cases. There are currently no treatments for the condition other than broad-spectrum antibiotics and surgical removal of diseased tissue.

Atox Bio is founded by molecular biologist Raymond Kaempfer and immunologist Gila Arad at Hebrew University in Jerusalem who study protein macromolecules serving as pathways that regulate inflammatory responses, including severe infections like those in necrotizing soft tissue infections. AB103 is Atox Bio’s lead product, which unlike traditional antibiotics designed to kill bacteria, aims to boost the immune system’s response to the infection. This approach, says the company, can cover a broad range of pathogens, yet still avoid the risk of drug resistance.

The clinical trial aims to recruit 290 patients with necrotizing soft tissue infections at 15 sites in the U.S. All participants will receive standard antibiotic, surgical, and organ dysfunction treatments, while patients will be randomly assigned to receive a single dose of AB103 or a placebo immediately after surgery to remove diseased tissue. The study is looking primarily for survival after 28 days, as well as amputations needed after surgical removal of diseased tissue, and standard assessment scores of organ failure after 14 and 28 days. The team is also tracking adverse events and other safety measures, as well as recovery from acute kidney injury, and amount of time in critical care units and hospitals overall.

Atox Bio says an intermediate-stage trial of AB103 shows patients receiving the drug experienced consistent and meaningful improvement. AB103 is designated as an orphan drug by European Medicines Agency and Food and Drug Administration in the U.S. FDA also granted AB103 fast track review status. In addition, the U.S. Biomedical Advanced Research and Development Authority, responsible for countermeasures for public health threats, supported development of AB103.

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