Infinant Health Announces Submission Of Orphan Drug Designation Application

Davis, CA /PRNewswire/ - Infinant Health, a privately-held company focused on changing the trajectory of human health, one baby at a time, announced it has filed an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for its drug candidate INF108 for the prevention of necrotizing enterocolitis in pre-term infants.

Necrotizing enterocolitis, or NEC, is the death of intestinal tissue primarily seen in preterm infants. It occurs when the intestinal wall lining becomes inflamed and dies. Although the cause for this disorder is unknown, it is thought that a decrease in blood flow to the bowel keeps the bowel from producing mucus that protects the gastrointestinal tract.1 Certain types of bacteria in the intestine may also be a cause. Necrotizing enterocolitis (NEC) claims at least one infant per day in the United States, with an estimated 500 deaths per year. Those with a higher risk for this condition include:

• Premature infants
• Infants who are fed concentrated formulas
• Infants who have received blood transfusions^1,2

Infinant Health's patented drug candidate is a Bifidobacterium longum subspecies infantis strain, INF108, which is not yet commercially available. Many years of proprietary research conducted by the Founders of Infinant Health focused on human milk and its impact on human development led to the groundbreaking discovery of the partnership between human milk and Bifidobacterium infantis (B. infantis). B. infantis is well adapted to work with human milk to establish in the infant gut microbiome, able to break down human milk oligosaccharides (HMOs) which are otherwise undigestible by the infant. HMOs are a type of carbohydrate found in breastmilk and serve as a nutrient for B. infantis. Unfortunately, B. infantis has nearly been eradicated from infants in industrialized countries like the US, which may be an unintended consequence of modern medicine.  The concern is infants today are likely to have a disruption in their microbiome, which can affect gut health, immune health, and result in disease.

"We have a number of Neonatology partners who have been anxiously awaiting our ODD submission because they believe in this product and its potential to save lives", says CEO Mike Johnson, "We work in this space because we have seen the impact our technology can have to support suffering babies and their families."

Strong scientific and clinical evidence suggests that B. infantis is associated with a significant reduction in the incidence of necrotizing enterocolitis and NEC-related mortality in very low birth weight infants.  The microbiomes of preterm infants given B. infantis also contain lower levels of antibiotic resistance organisms and show biomarkers for reduced gut inflammation.

The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Orphan Drug Designation would qualify INF108 for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval.

About Infinant Health, Inc 
Infinant Health, Inc ("Infinant Health"), previously known as Evolve Biosystems, is a privately held company committed to changing the trajectory of human health by supporting the development of healthy immune systems via the gut microbiome.  Infinant Health is building a product pipeline to optimize infant health.  Past and present investors in the company include the Bill and Melinda Gates Foundation, Johnson & Johnson, Cargill, and other leading institutions. Learn more about Infinant Health at www.infinanthealth.com.

References:
^1. Hackman, David Necrotizing Enterocolitis | Johns Hopkins Medicine

^2. Gephart SM, Spitzer AR, Effken JA, Dodd E, Halpern M, McGrath JM. Discrimination of GutCheck(NEC): a clinical risk index for necrotizing enterocolitis. J Perinatol. 2014 Jun;34(6):468-75.