Researchers will explore potential role of probiotics in immune activation

GAITHERSBURG, Md., Aug. 18, 2015 /PRNewswire-USNewswire/ — ExeGi Pharma has announced participation in a clinical trial funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to study the probiotic Visbiome™ in people living with HIV. Conducted by the NIH-funded AIDS Clinical Trials Group (ACTG), the study will evaluate the safety, tolerability and effect of probiotics on the gut microbiome and immune activation markers in people living with HIV who are currently on suppressive antiretroviral therapy (ART). In early stages of HIV infection, both the immune function of the gastrointestinal tract and its microbiome are altered and fail to normalize, even when patients are treated with ART over many years.

In this study, researchers will examine whether alterations to the intestinal microbial environment can affect key markers of disease progression.
The study is a 9-month-long, prospective, randomized, placebo-controlled clinical trial. ACTG sites throughout the United States will recruit study participants. The ACTG network is one of the largest international cooperative groups focused on HIV research, with over 59 research sites around the world. The ACTG, established in 1987, has played a key role in the development and optimization of treatment for HIV infection.

“We are pleased to support this research effort by the NIH/NIAID and the ACTG,” said Marc Tewey, chief executive officer of ExeGi. “The probiotic formulation that makes up Visbiome™ has been extensively studied in numerous gastrointestinal disorders, and this investigation of its potential impact for people living with HIV reflects our growing scientific understanding of the relationship between the gut microbiome and human health.”

“This study builds on previous research in which the immune defects of HIV are related to effects of the virus on the lymphoid tissue in the gastrointestinal tract and the subsequent alterations in the intestinal microbiome,” said Adriana Andrade MD, MPH, FACP, Associate Professor of Medicine at Johns Hopkins Hospital. “The results of this study will provide novel insights about the potential for probiotics to improve immune function and decrease intestinal and systemic inflammation, important drivers for disease in people living with HIV,” added fellow investigator, Edgar Turner Overton MD, Associate Professor of Medicine at the University of Alabama at Birmingham.

About ExeGi Pharma
ExeGi Pharma LLC, is a biotechnology company focused on the development and commercialization of live biotherapeutic and probiotic medicines. ExeGi’s team leverages scientific expertise in the field of microbiome science to deliver novel, clinically-supported live biotherapeutic and probiotic treatments for a variety of unmet medical needs. ExeGi is headquartered in Gaithersburg, MD.

About the ACTG
The AIDS Clinical Trials Group (ACTG) is an international collaboration of clinical investigators with the mission of conducting translational research and therapeutic clinical trials to evaluate novel therapeutic agents and the most effective approaches to treat HIV-1 infection. The ACTG conducts all phases of clinical trials, from evaluating safety through testing for efficacy. Support for the ACTG is provided through a cooperative agreement from the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). The Network’s HIV Clinical Trial Units are located at leading research institutions in 47 cities on four continents. Internationally recognized HIV researchers lead the units.