FDA Grants Orphan Drug & Rare Pediatric Disease Designations To Infinant Health For NEC

(MENAFN- PR Newswire)

DAVIS, Calif., May 7, 2025 /PRNewswire/ -- Infinant Health, a privately-held company focused on changing the trajectory of human health - one baby at a time - announced today that the U.S. Food and Drug Administration (FDA) has granted both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) to its investigational drug candidate, INF108, for the prevention of necrotizing enterocolitis in preterm infants.

Necrotizing enterocolitis, or NEC, is a life-threatening condition marked by the death of intestinal tissue, affecting preterm infants. It occurs when the intestinal lining becomes inflamed and begins to deteriorate. While the exact cause remains unknown, it is believed that a decrease in blood flow to the bowel keeps the bowel from producing mucus that protects the gastrointestinal tract. Certain types of bacteria in the intestine may also be a cause. NEC is a leading cause of death in preterm infants, impacting thousands of babies every year.

"Securing this Orphan Drug Designation sends a positive message to the neonatology community," said Mike Johnson, CEO of Infinant Health. "The Rare Pediatric Disease Designation is an important step toward securing a priority review voucher upon the approval of INF108, which will help accelerate our clinical development and bring hope to families facing limited options for NEC prevention."

The FDA grants ODD to therapies intended to treat, diagnose, or prevent rare diseases or disorders affecting fewer than 200,000 people in the US. The designation offers benefits such as tax credits and, if approved for marketing, market exclusivity. The RPDD grants the company a priority review voucher (PRV), provided approval for INF108 occurs before the RPD program sunsets. If Congress does not renew the program, it will sunset in September 2026. A PRV can be used to ensure priority review for a future marketing application, or it can be sold to help fund commercialization efforts or future clinical trials.

Infinant Health plans to initiate a human clinical trial with a patented investigational drug, INF108 (a strain of Bifidobacterium longum subspecies infantis), for use in preterm infants.

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 through gut microbiome science. The company is building a product pipeline to optimize infant health. Past and present investors in the company include the Bill Gates Foundation, Johnson & Johnson, Cargill, and other leading institutions. Learn more about Infinant Health at .

SOURCE Infinant Health

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