ViroStatics, a private Italian/American biopharmaceutical company developing novel therapeutics for viral and other chronic diseases, announced that a review of the first human clinical trial to test a new class of anti-HIV medications known as AntiViral-HyperActivation Limiting Therapeutics (AV-HALTs) has been published in the peer-reviewed journal PLoS ONE. The Phase 2a study demonstrated that markers of immune system hyperactivation driving HIV disease progression can be rapidly and effectively reduced by AV-HALTs, resulting in a proportional restoration of immune system damage.
“It has been more than thirty years since the first AIDS cases were reported”
"It has been more than thirty years since the first AIDS cases were reported," said Franco Lori, MD and CEO of ViroStatics. "Since these first reports, the field has made great advances against HIV. Yet, an unmet medical need remains - how to directly reduce the immune system's excessive response to the virus, a response that paradoxically becomes harmful over time."
"To test the AV-HALT concept in HIV, we developed VS411 as a two-drug combination product designed to accomplish two distinctive goals," Dr. Lori explained. "First, to reduce circulating virus as the currently approved HIV/AIDS medications do. Secondly, VS411 is the first of a new class of HIV antivirals that also directly target the inappropriately elevated level of immune system activation experienced by HIV-infected people. This excessive hyperactivation begins within the first weeks of HIV infection, lasts throughout the disease, and is now recognized as the driver behind immune system exhaustion, the loss of CD4+ T cells, non-AIDS events, and the onset of AIDS."
This second mechanism is so unique that drugs effectively accomplishing both goals are now known as a new class that ViroStatics has pioneered and named Antiviral-HyperActivation Limiting Therapeutics (AV-HALTs). To test the proof-of-concept that VS411, an AV-HALT containing both an antiviral and an anti-proliferative drug, could both inhibit viral replication and directly reduce markers of excessive immune system activation, a 28-day Phase 2a study followed traditional safety and efficacy parameters as well as measurements of four accepted markers of immune system hyperactivation - PD-1 (exhaustion), Ki-67 (proliferation), CD38 (activation), and HLA-DR (activation).