FDA Awards Orphan Drug and Rare Pediatric Disease Status to Infinant Health for NEC

DAVIS, Calif., May 7, 2025 – Infinant Health, a privately-owned enterprise dedicated to transforming human health from infancy, has announced a milestone achievement. The U.S. Food and Drug Administration (FDA) has granted the company both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) for its experimental drug, INF108. This drug is aimed at preventing necrotizing enterocolitis (NEC) in premature infants.

NEC is a severe and often life-threatening condition that affects the intestines of preterm babies. It involves the inflammation and subsequent deterioration of the intestinal lining, leading to the death of intestinal tissue. Although the specific cause of NEC is still not fully understood, it is believed that reduced blood flow to the bowel compromises its ability to produce protective mucus. Additionally, certain intestinal bacteria might play a role in the onset of the condition. NEC is a predominant cause of mortality among preterm infants, affecting thousands of newborns each year.

Mike Johnson, CEO of Infinant Health, expressed optimism regarding the FDA’s decision. "Securing Orphan Drug Designation is a significant boost for the neonatology community," he stated. He further emphasized that receiving the Rare Pediatric Disease Designation is crucial for obtaining a priority review voucher upon INF108's approval. This step will facilitate the acceleration of clinical development, offering hope to families with limited preventive options against NEC.

The FDA’s ODD is reserved for treatments targeting rare diseases or conditions impacting fewer than 200,000 individuals in the United States. This designation comes with certain benefits, including tax incentives and the potential for market exclusivity if the drug is approved for commercial sale. The RPDD, on the other hand, enables the company to receive a priority review voucher (PRV), which is contingent upon the approval of INF108 before the potential expiration of the RPD program in September 2026. Should Congress choose not to renew the program, it will come to an end at that time. A PRV can expedite the review process for a subsequent marketing application, or it may be sold to generate funds for commercialization or future clinical research.

Infinant Health is preparing to begin a human clinical trial for its novel investigational drug INF108. This patented drug is based on a strain of Bifidobacterium longum subspecies infantis and is intended specifically for preterm infants.

Infinant Health, originally known as Evolve Biosystems, is a private company committed to enhancing human health by fostering the development of robust immune systems through advancements in gut microbiome science. The company is actively developing a range of products aimed at optimizing infant health. It has received investments from prominent entities, such as the Bill Gates Foundation, Johnson & Johnson, and Cargill, among other notable institutions.