DAVIS, California, March 11, 2021 / PRNewswire / – Evolve BioSystems, Inc. today announced that its B. infantis EVC001 activated product has been used in one of the largest international clinical trials for the prevention of type 1 diabetes (T1D) in genetically predisposed children. The randomized, controlled, double-blind, multicenter study is being carried out in eight major research centers in five European countries.
The Leona M. and Harry B. Helmsley Charitable Trust are funding the study and the continuation of the established newborn screening with more than $ 30 million.
The SINT1A study (supplemented with B. infantis to reduce type 1 diabetes autoimmunity) is intended to show that daily administration of activated B. infantis EVC001 over the first year of life to children who are genetically predisposed to T1D promotes development significantly reduced by beta. Cell autoantibodies in the blood. Beta cell autoantibodies are produced by the immune system as part of the process that destroys insulin-producing cells in the pancreas, leading to an early onset of T1D.
“The prevalence of T1D has risen dramatically over the past 60 years. The results of this study could therefore have a huge public health impact if the increasing incidence of T1D and its physical, emotional and financial consequences could be reversed.” said Dr. David Kyle, Chief Scientific Officer, Evolve BioSystems, Inc. “We hope to show that simple intervention of activated B. infantis EVC001 can be life-changing from infancy to reduce the prevalence of this autoimmune disease that would have far-reaching economic and societal benefits . ”
T1D, also known as juvenile diabetes or autoimmune diabetes, can develop in the first few years of life and today affects 1.6 million Americans. It is a lifelong disease with no cure or prevention and requires multiple daily injections of insulin to treat.
Intestinal inflammation is often caused by an imbalance in the infant’s intestinal microbiota in the first few months of life due to a lack of the major intestinal bacteria Bifidobacterium infantis (B. infantis). A multitude of evidence has linked intestinal inflammation to defective immune programming and the subsequent development of autoimmune diseases such as T1D, eczema, food allergies, and asthma. A randomized controlled trial in Finland, previously announced in March 2020 by Evolve and in partnership with Janssen Research & Development, LLC1, one of Johnson & Johnson’s Janssen Pharmaceutical Companies, is currently investigating how activated B. infantis EVC001 will inhibit the onset of atopic dermatitis in the first year of life.
Details on the SINT1A study
SINT1A is a researcher-initiated, randomized, placebo-controlled, double-blind, multicenter intervention study at eight study sites in Belgium, Germany, Poland, Swedenand the UK. The research teams will work under the direction of a renowned T1D researcher Anette-G. Ziegler, Director of the Institute for Diabetes Research at the Helmholtz Zentrum München and founding member of the GPPAD.
“There is ample evidence of the importance of having a healthy gut microbiome in early childhood to prevent immune-mediated diseases such as type 1 diabetes,” said Dr. Ziegler. “By identifying children who are genetically predisposed to type 1 diabetes early and treating their bowel disorders, we can potentially protect them from developing this dangerous and costly disease.”
The study, one of the largest T1D studies to date, will screen approximately 300,000 newborns for a high genetic predisposition to T1D. Researchers will enroll 1,144 participants. Within the first six weeks of life up to the age of 12 months, half of the study participants received the dietary intervention of activated B. infantis EVC001 and the other half received a placebo. The intervention phase is followed by an observational examination every six months up to a maximum age of 6.5 years to assess the presence of autoantibodies associated with T1D in the blood. The study plans to enroll the first patients April 2021.
About Evolve BioSystems, Inc.
Evolve BioSystems, Inc. is a privately held microbiome company engaged in research into solutions to establish, restore, and maintain a healthy gut microbiome. Evolve is a portfolio company of Cargill, Manna Tree, the Bill & Melinda Gates Foundation, and Horizons Ventures, the venture division of the Li Ka Shing Foundation. Evolve is a spin-off from the Foods for Health Institute (FFHI) on University of California, Davis and builds on more than a decade of research to understand the unique partnership of the gut microbiome and breast milk components. Together with clinical research partners around the world, Evolve has developed a new understanding of the microbiome, biochemistry, and physiology of the infant intestine, which has been documented in numerous peer-reviewed publications.
1 The legal entity of the agreement with Evolve is Johnson & Johnson Consumer Inc.
SOURCE Evolve BioSystems
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