HHS funds drug development for cytokine storm

The US Department of Health and Human Services announced a $4.4 million contract with an Israeli biotechnology company to develop an investigational drug, AB103, to treat a life-threatening complication from severe infection known as cytokine storm.

Also known as hypercytokinemia, cytokine storm is a potentially fatal condition in which cells release excessive levels of cytokines — chemicals that modulate inflammatory and immune responses to severe infections, such as skin and soft tissue infections caused by Streptococcus pyogenes. The condition can result in tissue and organ damage and cause severe systemic inflammatory response associated with high mortality.

According to HHS, AB103 modulates the body’s cytokine response without repressing normal immune function, and could be used to reduce inflammation. Because the drug targets the immune system and not bacteria, it would be unaffected by drug resistance.

The 18-month contract with Atox Bio of Israel is supported by the initial $4.4 million from HHS, but it could be extended by another 3 years, totaling $23.9 million. The Biomedical Advanced Research and Development Authority (BARDA), within the HHS Office of the Assistant Secretary for Preparedness and Response, would oversee AB103’s development.

“Novel, host directed therapies like AB103 that target the immune system can help us address unmet medical needs such as necrotizing fasciitis, a severe skin and soft tissue infection,” BARDA Director Robin Robinson, PhD, said in a press release. “AB103 illustrates one of several approaches that BARDA is supporting as part of President Obama’s new initiative to combat antimicrobial resistance.”

Atox Bio also will conduct clinical trials to demonstrate the treatment’s efficacy in patients with severe skin or soft tissue infections. In addition, BARDA is interested in evaluating the drug against a range of bioterrorism threats, including tularemia and plague.