Landmark Study to Address Global Malnutrition and Restorative Effect of Infant Probiotic

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Funded By the Bill & Melinda Gates Foundation, Study Between Evolve BioSystems and the International Centre for Diarrhoeal Disease Research Will Determine Impact of Evivo Probiotic on Infants with Severe Acute Malnutrition

Davis, California, April 17, 2018 – Evolve BioSystems, Inc. and the icddr,b (International Centre for Diarrhoeal Disease Research, Bangladesh) today announced their collaboration, funded by the Bill & Melinda Gates Foundation, to study the use of Evivo® in infants to aid in recovery from severe acute malnutrition (SAM). Evivo is an activated form of the beneficial bacteria Bifidobacterium longum subsp. infantis (B. infantis EVC001, ActiBif®) and is used in infants to restore important bacteria to the gut microbiome. The study, which begins this year, will enroll infants under six months of age who are diagnosed with SAM as well as non-malnourished infants under six months of age who are hospitalized for infections. All study participants will be enrolled and treated at Dhaka Hospital (icddr,b) in Bangladesh.

“Thanks to increased investments in global health in the last 25 years, we have seen dramatic improvements in child health. However, one in five children still suffer from malnutrition and associated health threats,” said Dr. Chris Damman, Senior Program Officer on the Enteric, Diarrheal Diseases team at the Bill & Melinda Gates Foundation. “We know that there are components of the microbiome which are missing in children with malnutrition and are associated with growth and response to vaccines. We are pleased to support this study by icddr,b and Evolve to determine if we can stably replace these microbiome components with an ultimate goal of stimulating healthy growth and resistance to infection.”

Addressing the effects of dysbiosis on malnutrition

It is estimated that over eighteen million children under the age of five are affected by the most extreme form of malnutrition, SAM, and are 12 times more likely to die than well-nourished children. “We know that children with severe malnutrition are some of the most vulnerable. In the six months after they are discharged from hospital, too many get another infection or even die,” said Supriya Kumar, Program Officer at the Bill & Melinda Gates Foundation. “There is an urgent need to find ways to improve their chances of not only surviving but also thriving.”

Although improvements can be made by providing malnourished children with therapeutic food and specialized formula, there is still a population resistant to these nutritional interventions. Research conducted at the icddr,b indicates that an imbalance in gut bacteria, known as dysbiosis, is related to the underutilization of nutrition received by these infants which mediates some of the pathology of their condition.

“Evolve BioSystems is proud to partner with premier institutions like the Bill & Melinda Gates Foundation and the icddr,b to help find a new intervention for severe acute malnutrition in this extremely vulnerable infant population,” said David Kyle, PhD, Chief Scientific Officer at Evolve BioSystems. “Along with adequate nutrition, children in this study will receive Evivo, which is proven to correct gut dysbiosis in breastfed infants, and it may help improve weight gain during nutritional rehabilitation and reduce infections during a time of increased susceptibility.”

Restoring the infant gut microbiome

In 2017, Evolve BioSystems’ landmark clinical study supporting the use of Evivo showed that providing dietary B. infantis EVC001 to breastfed infants resulted in rapid, substantial, and persistent remodeling of the gut microbiome. This stable colonization of B. infantis EVC001 led to significant reduction in the abundance of potentially harmful bacteria and improved utilization of nutrients in breast milk that were otherwise excreted in stool of unsupplemented infants.

“The exciting clinical results from our colleagues at Evolve BioSystems and our own research on the infant gut microbiome support the initiation of this study examining B. infantis EVC001 as a therapeutic intervention in infants with SAM,” said Dr. Tahmeed Ahmed, Senior Director, Nutrition & Clinical Services at icddr,b and Principal Investigator of the clinical study. “We’re pleased to work with the Bill & Melinda Gates Foundation and Evolve BioSystems to treat this underserved infant population.”

About Evolve BioSystems

Evolve BioSystems, Inc. is a privately-held microbiome company dedicated to developing the next generation of products to establish, restore, and maintain a healthy gut microbiome. Evolve is a spin-out 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. Having led to the development and commercial launch of products to resolve newborn gut dysbiosis, including Evivo for infants and GlycoGuard for nursing foals, Evolve’s discovery platform is now being applied to solving gut dysbiosis throughout the human life cycle as well as other animal species. In addition to the landmark proof-of-concept trial, Evolve is undertaking further clinical studies to build out its suite of microbiome-based solutions.

About the International Centre for Diarrhoeal Disease Research

icddr,b is an international public health research institution based in Bangladesh. Established in 1960, icddr,b has been at the forefront of discovering low cost solutions to key health challenges facing people living in poverty and provides robust evidence of their effectiveness at a large scale. Dedicated to saving lives through research and treatment, icddr,b addresses some of the most critical health concerns facing the world today.

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