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Evolve BioSystems, Inc. Announces the Use of Activated B. infantis EVC001 by International Consortium to Study the Prevention of Type 1 Diabetes in Children

Major T1D Primary Prevention Trial Will Contribute to Global Evidence Supporting Healthy Infant Gut Microbiome to Address Autoimmune Disorders

Study is led by the Institute for Diabetes Research at Helmholtz Zentrum München and conducted by the Global Platform for the Prevention of Autoimmune Diabetes

DAVIS, Calif., March 11, 2021-- Evolve BioSystems, Inc. today announces that its product, activated B. infantis EVC001, will be used in one of the largest international clinical studies on preventing type 1 diabetes (T1D) in genetically predisposed children.  The randomized, controlled, double-blind, multicenter trial will be conducted across eight major research centers in five European countries.

The Leona M. and Harry B. Helmsley Charitable Trust is funding the study and the continuation of the established newborn screening with more than $30 million.

The SINT1A study (Supplementation with B. infantis for Mitigation of Type 1 Diabetes Autoimmunity) aims to show that the daily administration of activated B. infantis EVC001 through the first year of life to children genetically predisposed to T1D will significantly reduce the development of 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, thus leading to T1D onset early in life.

"The prevalence of T1D has grown dramatically over the past 60 years, so the results of this study could have an enormous impact on public health if the increasing incidence of T1D, and its physical, emotional and financial consequences, could be turned back," said Dr. David Kyle, Chief Scientific Officer, Evolve BioSystems, Inc. "We hope to show that a simple intervention of activated B. infantis EVC001 starting in infancy could be life-altering in reducing the prevalence of this autoimmune condition, which would have far-reaching economic and societal benefits." 

T1D, also known as juvenile diabetes or autoimmune diabetes, can develop in the first years of life, and affects 1.6 million Americans today. It is a lifelong disease for which there is no cure, no means of prevention, and that requires multiple daily insulin injections to manage.

Gut inflammation is often caused by an imbalance in the infant gut microbiota in the first few months of life as the result of a deficiency of the key gut bacteria, Bifidobacterium infantis (B. infantis). A substantial body of evidence has connected gut inflammation with improper immune programming and the subsequent development of autoimmune conditions including T1D, atopic dermatitis, food allergies and asthma.  A randomized controlled trial in Finland, previously announced in March 2020 by Evolve and in collaboration with Janssen Research & Development, LLC1, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is underway to assess the impact of activated B. infantis EVC001 on inhibiting the onset of atopic dermatitis in the first year of life.

SINT1A Study Details
SINT1A is an investigator-initiated, randomized, placebo-controlled, double-blind multi-center intervention study across eight trial sites in Belgium, Germany, Poland, Sweden, and the United Kingdom.  Research teams will operate under the direction of renowned T1D researcher Anette-G. Ziegler, Director of the Institute for Diabetes Research at Helmholtz Zentrum München and founding member of GPPAD.

"There is a great deal of evidence pointing to the importance of having a healthy gut microbiome in early childhood for preventing immune-mediated diseases like type 1 diabetes," said Dr. Ziegler.  "By identifying children genetically predisposed to type 1 diabetes early in life and treating their gut imbalances, we could potentially protect them from developing this dangerous and costly disease."

The study, among the largest T1D studies to date, will screen approximately 300,000 newborn babies for high genetic predisposition for T1D.  Researchers will enroll 1,144 participants.  Within the first six weeks of life through to age 12 months, half of the study participants will receive the dietary intervention of activated B. infantis EVC001 and the other half will receive a placebo. The intervention phase will be followed by observational follow-up every six months up to a maximum age of 6.5 years to assess the presence in the blood of autoantibodies associated with T1D.  The study plans to enroll its first patients in April 2021.

About Evolve BioSystems, Inc.
Evolve BioSystems, Inc. is a privately-held microbiome company dedicated to researching 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) at the University of California, Davis and builds on more than a decade of research into understanding the unique partnership of the infant gut microbiome and breast milk components. Together with clinical research partners all over the world, Evolve has pioneered a new understanding of the infant gut microbiome, biochemistry and physiology, which it has documented in numerous peer reviewed publications.

1 The legal entity to the agreement with Evolve is Johnson & Johnson Consumer Inc.