/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..

/PRNewswire/ -- 致力于改变人类健康轨迹的私营公司Infinant Health今日宣布，美国食品药品监督管理局（FDA）已授予其在研药物候选物INF108用于预防早产儿坏死性小肠结肠炎的孤儿药资格（ODD）和罕见儿科疾病资格（RPDD）。

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.

坏死性小肠结肠炎（NEC）是一种危及生命的疾病，以肠道组织坏死为特征，主要影响早产儿。它发生在肠壁内层发炎并开始恶化时。虽然确切原因尚不清楚，但人们认为肠道血流减少会导致肠道无法分泌保护胃肠道的黏液。

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..

肠道中的某些细菌也可能是一个原因。NEC是早产儿死亡的主要原因之一，每年影响数千名婴儿。

'Securing this Orphan Drug Designation sends a positive message to the neonatology community,' said

“获得这一孤儿药资格认证向新生儿科社区传递了积极的信息，”表示

Mike Johnson

迈克·约翰逊

, 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.'

Infinant Health首席执行官表示：“罕见儿科疾病认定是INF108获批后获得优先审查凭证的重要一步，这将有助于加速我们的临床开发，并为面临NEC预防选择有限的家庭带来希望。”

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.

FDA授予ODD用于治疗、诊断或预防在美国影响不到20万人的罕见疾病或病症的疗法。该指定提供税收抵免等好处，如果获准上市，还享有市场独占权。RPDD授予公司优先审查券（PRV），但前提是INF108需在RPD计划结束前获得批准。

If Congress does not renew the program, it will sunset in .

如果国会不续签该计划，它将在到期。

September 2026

2026年9月

. 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.

优先审评券（PRV）可用于确保未来上市申请的优先审评，或者可以出售以帮助资助商业化工作或未来的临床试验。

Infinant Health plans to initiate a human clinical trial with a patented investigational drug, INF108 (a strain of

Infinant Health 计划启动一项使用专利研究药物 INF108（一种菌株）的人类临床试验，

Bifidobacterium longum

长双歧杆菌

subspecies

亚种

infantis

婴儿

), for use in preterm infants.

），用于早产儿。

ABOUT INFINANT HEALTH, INC

关于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.

Infinant Health, Inc（“Infinant Health”），前身为Evolve Biosystems，是一家致力于通过肠道微生物组科学支持健康免疫系统发育，从而改变人类健康轨迹的私人公司。该公司正在构建一条产品管线以优化婴儿健康。

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 .

公司过去和现在的投资者包括比尔及梅琳达·盖茨基金会、强生公司、嘉吉公司和其他领先机构。更多关于Infinant Health的信息请访问。