ExeGi Pharma Celebrates 25th Anniversary of Landmark De Simone Formulation

Rockville, Md. – ExeGi Pharma, a biotechnology company specializing in live biotherapeutics, today announced the 25th anniversary of the De Simone Formulation, a high potency probiotic blend that has transformed the landscape of gastrointestinal care. The formulation first gained clinical prominence in August 2000, when Professor Paolo Gionchetti and colleagues published a landmark study demonstrating that this probiotic benefits in a serious chronic inflammatory gastrointestinal disorder called pouchitis.¹ That 2000 study – a breakthrough for the probiotic industry – showed significant benefits vs placebo and underscored the formulation’s potential to alter the course of serious gastrointestinal conditions. It also marked one of the first times a probiotic therapy proved superior to placebo in a rigorous clinical trial which was published in one of the premier peer-reviewed medical journals. 

Over the past 25 years, the scientific and clinical impact of the De Simone Formulation has been profound. It has become one of the most extensively studied probiotic formulations in the world, serving as the subject of more than 100 clinical trials to date. These studies span a range of conditions, and the formulation’s benefits have led to its inclusion in international treatment guidelines for gastrointestinal disorders. Notably, professional societies such as the American Gastroenterological Association (AGA) and the European Crohn’s and Colitis Organisation (ECCO) have recognized the De Simone Formulation in their clinical guidelines for managing pouchitis and other inflammatory bowel conditions.^2,3 Today, this probiotic blend is used to aid in the dietary management of ulcerative colitis, pouchitis, and irritable bowel syndrome (IBS),  reflecting a broad impact on patients across multiple disorders.

“In 2000, our clinical team was excited – and a bit astonished – to observe such a dramatic therapeutic benefit from a probiotic preparation in patients with chronic severe pouchitis,” said Professor Paolo Gionchetti, Professor of Internal Medicine at the University of Bologna.

Professor Fernando Rizzello, a co-author of the original 2000 study, added: “At the time, the idea of using beneficial bacteria to maintain remission in a serious inflammatory condition was revolutionary. Twenty-five years later, it’s gratifying to see how the De Simone Formulation has not only validated that concept but also significantly influenced patient care. This formulation has provided physicians with an important tool for managing complex gastrointestinal disorders in a natural, well-tolerated way. Its success has paved the way for a new era of microbiome-based therapies, and, more importantly, it has made a tangible difference in the lives of patients who struggle with these chronic conditions.”

The De Simone Formulation was originally invented by Professor Claudio De Simone, MD, and was introduced commercially in the early 2000s. In 2016, ExeGi Pharma partnered with Professor De Simone to launch the formulation under the brand name Visbiome® in the United States. Since then, ExeGi has ensured that this rigorously studied probiotic blend remains available to patients and healthcare providers and continues to be produced with the same high-quality standards and composition used in the clinical trials. As the company commemorates 25 years since the formulation’s clinical debut, ExeGi Pharma reaffirms its commitment to advancing probiotic research and supporting patients with innovative microbiome-based solutions.

About ExeGi Pharma

ExeGi Pharma is a biotechnology company focused on the development and commercialization of live biotherapeutic and probiotic medicines. The company’s team leverages deep scientific expertise in microbiome research to deliver novel, clinically supported probiotic treatments for a variety of unmet medical needs in both people and pets. ExeGi Pharma is the exclusive U.S. licensee of the De Simone Formulation and markets it under the Visbiome® brand for the dietary management of conditions such as pouchitis, inflammatory bowel disease, and IBS. Headquartered in Rockville, Maryland, ExeGi Pharma continues to innovate in the field of gut health and is dedicated to improving patient outcomes through evidence-based probiotic therapies.

References

1.    Gionchetti P, et al. Gastroenterology. 2000;119(2):305–309.
2.    Barnes EL, et al. Gastroenterology. 2024;166(1):59-85.
3.    Margo F, et al. J Crohn’s Colitis. 2017;11(6):649-670