Recruiting
Phase 1
Phase 2

ST266

Sponsor:

Noveome Biotherapeutics, formerly Stemnion

Code:

NCT06315738

Conditions

Necrotizing Enterocolitis

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

ST266

Study Details

Brief summary:

The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL/kg and 1.0 mL/kg) of once daily (QD) via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC by incidence of treatment emergent adverse events (TEAEs) and SAEs, with a secondary objective to assess preliminary efficacy of the same two dose levels (0.5 mL/kg and 1.0 mL/kg) of QD via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC.

Conditions

Necrotizing Enterocolitis

Study ID

NCT06315738

Start date

Aug 19, 2024

Status verified date

Apr, 2026

Completion date

Nov, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Infants born from ≥22 weeks gestational age up to and including 40 weeks gestational age; up to 40 weeks postmenstrual age (gestational age plus chronological age in terms of weeks) with current weight at diagnosis of NEC between ≥500g and ≤3000g, as a result of prematurity and/or IUGR. Parent(s)/legal medical representative(s) voluntarily provides written consent prior to study enrollment.
2. Bell's Stage IIA or higher medical NEC (Stages IIA - IIIA only) diagnosis by radiologic confirmed pneumatosis intestinalis and may include intestinal dilation and ileus. The clinician confirms NEC diagnosis by evaluation of the radiologic imaging for confirmed pneumatosis intestinalis. If X-ray is used and is equivocal, an ultrasound (US) may be used, if available, to confirm pneumatosis. If the clinician (Neonatologist and/or Pediatric Surgeon) has differing interpretation from that of the Radiologist, that should be documented in both the medical and research records for accuracy of NEC diagnosis.

Exclusion Criteria:

1. Infants with abdominal perforation.
2. Not expected to survive ≥2 weeks or born with a lethal condition requiring hospice or palliative care (e.g., disease has progressed to NEC totalis, or patient has multi-organ system failure).
3. Born with major congenital anomalies such as cardiac defects (e.g., Tetralogy of Fallot) or chromosomal disorders/anomalies (e.g., neural tube defect).
4. Mother's receipt of any investigational product during pregnancy.
5. Infants with malignancies (e.g., neoplastic cell growth as a solid tumor or a blood neoplasm, such as congenital leukemia).
6. Infants with hypercoagulability disorders (any active thrombosis, diagnosis of disseminated intravascular coagulation or other acquired/inherited disorders (i.e., hemophilia) of coagulation.
7. Infants with a known immunodeficiency (such as galactosemia or agranulocytosis).
8. Infants with anatomic defects that require surgical intervention.
9. Infants with persistent pulmonary hypertension of newborn.
10. Infants with any congenital or acquired gastrointestinal pathology that preclude feeds within 7 days after birth (e.g., duodenal atresia).
11. Infants who have hypoxic ischemic injury (perinatal asphyxia).
12. Infants with polycythemia (at time of treatment) (>22 g/dL).
13. Positive maternal human immunodeficiency virus status.
14. History of maternal drug abuse (such as amphetamines, opiates, cocaine). This does not include marijuana, or prescription medications for treatment of drug abuse.
15. Considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
16. Infants diagnosed with NEC who will require immediate surgical intervention.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Cohort 1 - lower dose active + SOC treatment vs. SOC alone in higher weight range

Infants with weight at diagnosis of NEC ≥1000 g and ≤3000 g; 0.5 mL/kg of ST266, QD, + Standard of Care (SOC) treatment (n=6); SOC (n=3)

other: Cohort 2 - higher dose active + SOC treatment vs. SOC alone in higher weight range

Infants with weight at diagnosis of NEC ≥1000 g and ≤3000 g; 1.0 mL/kg of ST266, QD; + Standard of Care (SOC) treatment (n=6); SOC (n=3)

other: Cohort 3 - lower dose active + SOC treatment vs. SOC alone in lower weight range

Infants with weight at diagnosis of NEC ≥500 g and ≤999 g; 0.5 mL/kg of ST266, QD; + Standard of Care (SOC) treatment (n=6); SOC (n=3)

other: Cohort 4 - higher dose active + SOC treatment vs. SOC alone in lower weight range

Infants with weight at diagnosis of NEC ≥500 g and ≤999 g; 1.0 mL/kg of ST266, QD; + Standard of Care (SOC) treatment (n=6); SOC (n=3)

Interventions

ST266

Patients randomized to investigative drug product (ST266) will receive either 0.5 mL/kg or 1.0 mL/kg of ST266 QD in addition to Standard of Care treatment; Patients randomized to SOC will receive standard of care treatment only.

Primary outcome measure

  • Safety and Tolerability endpoint: incidence of adverse events [ Time Frame: From date of randomization through 24 months of age ]
  • Safety and Tolerability endpoint: incidence of serious adverse events [ Time Frame: From date of randomization through 24 months of age ]
  • Safety and Tolerability endpoint: Changes in labs and vitals relative to disease progression [ Time Frame: From date of randomization through 24 months of age ]

Central Contacts and Locations

Central contacts

Karin Potoka, MD

412-512-1446kpotoka@noveome.com

Shawna M Rose, BS

513-205-1091srose@noveome.com

Locations

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Vikas Chowdhary, MD

501-364-1028vchowdhary@uams.edu

Principal Investigator:

Vikas Chowdhary, MD

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Vikas Chowdhary, MD

848-702-3188vchowdhary@uams.edu

Principal Investigator:

Vikas Chowdhary, MD

Yale-New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Sarah Taylor, MD

203-688-2320sarah.n.taylor@yale.edu

Principal Investigator:

Sarah Taylor, MD

BayCare Health System-St. Joseph's Women's Hospital

Recruiting

Tampa, Florida, United States, 33607

Contacts

Jenelle Ferry, MD

813-872-2924jenelle.ferry@baycare.org

Principal Investigator:

Jenelle Ferry, MD

NorthShore University-Evanston Hospital

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Brandy Frost, MD

773-562-7420bfrost@northshore.org

Principal Investigator:

Brandy Frost, MD

Oklahoma Children's Hospital

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Hala Chaaban, MD

405-271-5215hala-chaaban@ouhsc.edu

Principal Investigator:

Hala Chaaban, MD

Penn State Health Milton S Hershey Medical Center/Penn State University College of Medicine

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Timothy Palmer, MD

717-531-8413tpalmer@pennstatehealth.psu.edu

Principal Investigator:

Timothy Palmer, MD

University of Pittsburgh Medical Center Magee Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15219

Contacts

Toby Yanowitz, MD

412-641-6260yanotd@upmc.edu

Principal Investigator:

Toby Yanowitz, MD

More Information

Sponsor

Noveome Biotherapeutics, formerly Stemnion

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Necrotizing Enterocolitis
  • NEC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Noveome Biotherapeutics, formerly Stemnion on 2026-04-13.