Categories ArchivesClinical Studies

Rockville, MD – January 26th, 2023 ExeGi Pharma LLC, a leader in the development of live biotherapeutic drugs and probiotics, announced today that the FDA has cleared its Investigational New Drug (IND) application for its biologic drug candidate, EXE-346. This clearance allows the company to initiate a clinical trial for patients with an ileal pouch-anal anastomosis (IPAA or “J-Pouch”) who experience excessive stool frequency. “Excessive stool frequency is a significant challenge for many patients with a J-Pouch, and we are pleased to have the opportunity to investigate the potential benefits of EXE-346,” commented Dr. Hans Herfarth, MD, Ph.D., of the University of North Carolina Inflammatory Bowel Disease Center. And “We believe that the live biotherapeutic approach has the potential to ...

http://www.businesswire.com/news/home/20170502006014/en/Multi-Strain-Probiotic-Play-Role-Recovery-Critical-Gastrointestinal ROCKVILLE, Md.–(BUSINESS WIRE)–A newly released study published in the Journal ofImmunity, Inflammation and Disease and conducted by the Sapienza University of Rome, Italy, found a multi-strain, high concentration, probiotic formulation that helped reconstitute the physical and immunological integrity of the gastrointestinal lining in HIV-1-positive patients on antiretroviral therapy (ART). The human gastrointestinal (GI) tract is home to trillions of organisms which form a complex bacterial community, commonly referred to as the “gut microbiome.” A key function of the GI tract is to separate these bacteria from internal organs with a single layer of intestinal cells, called epithelial cells. The epithelial cells form a physical and immunological barrier to prevent entry of gut bacteria into the bloodstream. When this barrier breaks ...

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 ...