Necrotizing Enterocolitis Pipeline: Breakthrough Therapeutics Advancing in Neonatal Care | DelveInsight

Necrotizing Enterocolitis (NEC), a devastating gastrointestinal disease affecting neonates, especially preterm infants, has long lacked effective treatment beyond supportive care. However, innovative biotech companies such as Infant Bacterial Therapeutics and Noveome Biotherapeutics are advancing novel therapies, including live biotherapeutics, probiotics, and anti-inflammatory agents to combat NEC at its roots.

DelveInsight's "Necrotizing Enterocolitis - Pipeline Insight, 2025" tracks the progress of these emerging therapies, offering a granular view of the clinical pipeline, from early development to regulatory milestones. The report emphasizes key drug targets, trial outcomes, and development hurdles specific to this vulnerable population.

This pipeline report delivers a holistic 360° view of NEC drug development, highlighting the most promising candidates by development phase, route of administration, molecule type, and MOA. It also explores commercial potential, strategic partnerships, and growth forecasts aimed at improving neonatal outcomes and reducing NEC-associated mortality.

Key Takeaways from the Necrotizing Enterocolitis Pipeline Report
• DelveInsight's necrotizing enterocolitis pipeline analysis depicts a strong space with 2+ active players working to develop 2+ pipeline drugs for necrotizing enterocolitis treatment.
• The leading necrotizing enterocolitis companies include Infant Bacterial Therapeutics, Noveome Biotherapeutics, Siolta Therapeutics, and others are evaluating their lead assets to improve the necrotizing enterocolitis treatment landscape.
• Key necrotizing enterocolitis pipeline therapies in various stages of development include IBP-9414, ST266, STMC-106, and others.
• In May 2025, The NEC baby formula multidistrict litigation (MDL) added 27 new cases in April, bringing the total to approximately 710 pending cases in federal court, with additional cases in state courts, reflecting ongoing legal challenges for formula manufacturers.
• In May 2025, a U.S. federal judge allowed expert testimony asserting that preterm baby formulas produced by Abbott Laboratories and Mead Johnson can cause NEC, a significant decision as the companies face over 700 federal lawsuits.
• In February 2025, Dr. Venkatesh Sampath received a $2.5 million NIH grant to investigate the mechanisms underlying NEC in premature infants, aiming to enhance understanding and develop preventive strategies.
• In October 2024, The FDA, CDC, and NIH hosted a public workshop titled "Live Biotherapeutic Products to Prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants," focusing on regulatory and scientific issues related to live biotherapeutic products for NEC prevention.
• In September 2024, the NIH released a report recommending 17 strategies to advance research on NEC, emphasizing the need for a better understanding of disease mechanisms, early diagnosis, and the development of preventive and therapeutic interventions.
• In February 2024, researchers at Lurie Children's Hospital reported that recombinant human insulin-like growth factor 1 and its binding protein-3 (rhIGF-1/BP3) protected neonatal mice from NEC, paving the way for clinical trials targeting NEC prevention in preterm infants.

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Necrotizing Enterocolitis Overview
Necrotizing enterocolitis (NEC) is a serious gastrointestinal condition primarily affecting premature and low birth weight infants. It involves inflammation and bacterial invasion of the intestinal wall, leading to tissue damage, necrosis, and potentially life-threatening complications like intestinal perforation, peritonitis, sepsis, and death-with mortality rates reaching up to 50%. Symptoms are often nonspecific, including poor feeding, vomiting, lethargy, and abdominal tenderness, requiring early recognition and intervention for better outcomes.

The exact cause of NEC is not fully understood, but it is linked to a combination of factors such as prematurity, immature gut function, impaired blood flow, and a weakened immune response. Bacterial invasion and inflammation play key roles in disease progression. Formula feeding has been associated with higher NEC risk, possibly due to its impact on gut microbiota. Other contributing factors may include genetic predisposition and hypoxic events, particularly in infants with congenital heart conditions.

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Necrotizing Enterocolitis Treatment Analysis: Drug Profile
IBP-9414 - Infant Bacterial Therapeutics
IBP-9414 is a novel biological therapy developed to prevent necrotizing enterocolitis (NEC) in premature infants. It contains Lactobacillus reuteri, a beneficial bacterial strain naturally found in breast milk, known for its anti-inflammatory and gut-protective properties. The live bacterium supports gut motility, mucosal maturation, and reduces pathogenic activity-all critical factors in NEC prevention. In addition to reducing NEC risk, IBP-9414 aims to improve feeding, growth, and overall health in vulnerable neonates. The therapy is currently in Phase III development for NEC.

ST266 - Noveome Biotherapeutics
ST266 is an investigational, cell-free biologic therapy being developed by Noveome Biotherapeutics for the treatment of NEC. Derived from amnion-based cells, ST266 contains hundreds of bioactive proteins that work to reduce intestinal inflammation, inhibit TLR4 signaling, and support gut repair. Preclinical data have shown promising protective effects against NEC. The therapy has received Orphan Drug Designation and is currently in Phase I/II clinical trials.

Learn more about the novel and emerging necrotizing enterocolitis pipeline therapies @ https://www.delveinsight.com/report-store/necrotizing-enterocolitis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Necrotizing Enterocolitis Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

By Molecule Type
• Oligonucleotide
• Peptide
• Small molecule

Scope of the Necrotizing Enterocolitis Pipeline Report
• Coverage: Global
• Key Necrotizing Enterocolitis Companies: Infant Bacterial Therapeutics, Noveome Biotherapeutics, Siolta Therapeutics, and others.
• Key Necrotizing Enterocolitis Pipeline Therapies: IBP-9414, ST266, STMC-106, and others.

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Table of Contents
1. Introduction
2. Executive Summary
3. Necrotizing Enterocolitis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Necrotizing Enterocolitis Pipeline Therapeutics
6. Necrotizing Enterocolitis Pipeline: Late-Stage Products (Phase III)
7. Necrotizing Enterocolitis Pipeline: Mid-Stage Products (Phase II)
8. Necrotizing Enterocolitis Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
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About DelveInsight
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This release was published on openPR.