PITTSBURGH, PA – May 24, 2022 – Noveome Biotherapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) to the company’s lead product ST266 for the treatment of Necrotizing Enterocolitis (NEC).
“NEC is a devastating disease that affects the most vulnerable among us,” said Christopher Velis, Chief Executive Officer of Noveome. “We remain motivated by the prospect of providing the first major improvement in lifesaving therapy for infants affected by NEC in over 40 years. These babies, their families, and the doctors and nurses who have devoted their own lives to fighting this disease deserve our collective best efforts to advance our therapy into clinical practice.”
The FDA grants RPDD for serious and life-threatening diseases affecting children aged 18 years or younger and ODD for rare diseases that impact fewer than 200,000 people in the United States. ST266 is being evaluated in multiple preclinical animal models and the company is in the planning stages for clinical trials to investigate treatment with ST266 for NEC.
About Necrotizing Enterocolitis (NEC)
Necrotizing Enterocolitis (NEC) is a devastating disease caused by inflammation of the intestines observed primarily in premature and very low birth weight babies (VLBWB). The inflammation can result in an overwhelming infection which quickly becomes a medical emergency and often requires surgery as a life-saving measure. NEC affects between 4,000 – 6,000 VLBWB each year in the United States and carries a 30% mortality rate. Babies that do survive are often left with life-long intestinal complications and are also at increased risk for neurodevelopmental delay with cognitive, visual, and motor impairment. Treating and managing NEC costs over $5 billion annually in Neonatal Intensive Care Unit (NICU) expenditures.
There is currently no FDA-approved treatment for NEC.
ST266 is a cell-free sterile biologic solution containing hundreds of proteins and other factors at physiologic levels. Extensive preclinical studies have shown that ST266’s multiple components result in a variety of anti-inflammatory and neuroprotective responses. A drug master file has been submitted to the FDA, supporting all ST266 investigational new drug (IND) applications.
About Noveome Biotherapeutics, Inc.
Based in Pittsburgh, PA, Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologic therapeutics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Noveome has a robust pipeline developing novel treatments for various systemic and ophthalmic indications and has recently completed a Phase 1 study evaluating the safety of intravenously administered ST266 in the treatment of systemic inflammation associated with COVID-19. For more information, visit www.noveome.com.
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