ST266 for Necrotizing Enterocolitis

Recruiting at 6 trial locations

Overseen By Shawna M Rose, BS

Age: < 18

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Noveome Biotherapeutics, formerly Stemnion

Disqualifiers: Congenital anomalies, Malignancies, Hypercoagulability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 10 days

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ST266 for infants with necrotizing enterocolitis (NEC), a serious gut disease. Researchers aim to determine if this treatment is safe and improves the condition when combined with standard care. They compare two different doses of ST266 to identify the most effective and safe option. Infants born prematurely or with low birth weight, and who have NEC confirmed by specific signs on an X-ray, might be suitable for this study. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ST266 has demonstrated promise in early studies with animals like mice and piglets, where it helped protect against necrotizing enterocolitis. However, these results do not come from human studies.

This trial is in its early stages and primarily aims to determine if ST266 is safe for humans. Researchers are still carefully studying the treatment's safety. The transition from animal studies to human trials suggests that initial results were promising enough to warrant testing in people.

There is no specific information yet about how humans might react to ST266 or what side effects it might have. However, the trial's existence indicates some confidence in its potential safety. Researchers will closely monitor participants for any unwanted effects to ensure their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for NEC?

Unlike the standard treatment for necrotizing enterocolitis, which often involves antibiotics and surgery, ST266 offers a promising new approach. This treatment is derived from amniotic fluid, which contains a unique mix of growth factors and anti-inflammatory proteins that may help heal and protect the gut. Researchers are particularly excited about ST266 because it targets inflammation directly, potentially reducing the severity and progression of the disease more effectively than current options. Additionally, ST266 is administered once daily in small doses, making it a potentially less invasive option for treating this condition in fragile infants.

What evidence suggests that ST266 might be an effective treatment for necrotizing enterocolitis?

Research has shown that ST266, a substance derived from amnion cells, might protect against necrotizing enterocolitis (NEC), a serious gut condition. Studies in animals like mice and piglets found that ST266 can prevent and treat NEC by reducing swelling and tissue damage. Early results suggest that ST266 might work similarly in humans, but further research is needed for confirmation. In this trial, different cohorts will receive varying doses of ST266 alongside standard of care (SOC) treatment, while others will receive SOC alone. The goal is to discover a new way to help infants with NEC heal and recover more effectively. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for premature infants between 26 and 36 weeks of gestational age, weighing between 800g and 3000g, diagnosed with at least Bell stage IIA Necrotizing Enterocolitis (NEC), confirmed by specific radiologic signs. Parents or legal guardians must consent to the infant's participation.

Inclusion Criteria

Parent(s)/legal medical representative(s) voluntarily provide written consent prior to study enrollment

My diagnosis includes gas in the intestinal wall, possibly with swelling or blockage.

My baby was born between 26 and 36 weeks and weighs between 800g and 3000g.

Exclusion Criteria

Not expected to survive ≥2 weeks or born with a lethal condition requiring hospice or palliative care

I am HIV positive.

Mother's receipt of any investigational product during pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ST266 treatment via IV once daily for 10 days, with staggered dosing for the first 3 patients in each cohort

10 days

Daily visits for 10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 1 month follow-up visit

1 month

1 visit (in-person)

Long-term follow-up

Participants are monitored for long-term safety and efficacy outcomes, including assessments up to 24 months of age

24 months

What Are the Treatments Tested in This Trial?

Interventions

• ST266

Trial Overview The study tests two doses (0.5 mL/kg and 1.0 mL/kg) of ST266 given once daily through an IV to see if it's safe and can be tolerated in treating NEC in infants. It also looks at how effective these doses are against NEC.

How Is the Trial Designed?

Group I: Cohort 4 - higher dose active + SOC treatment vs. SOC alone in lower weight range Experimental Treatment 1 Intervention

Infants with weight at diagnosis of NEC ≥800 g and ≤999 g; 1.0 mL/kg of ST266, QD; + Standard of Care (SOC) treatment (n=6); SOC (n=3)

Group II: Cohort 3 - lower dose active + SOC treatment vs. SOC alone in lower weight range Experimental Treatment 1 Intervention

Infants with weight at diagnosis of NEC ≥800 g and ≤999 g; 0.5 mL/kg of ST266, QD; + Standard of Care (SOC) treatment (n=6); SOC (n=3)

Group III: Cohort 2 - higher dose active + SOC treatment vs. SOC alone in higher weight range Experimental Treatment 1 Intervention

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)

Group IV: Cohort 1 - lower dose active + SOC treatment vs. SOC alone in higher weight range Experimental Treatment 1 Intervention

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)

ST266 is already approved in United States for the following indications:

Approved in United States as ST266 for:

• Necrotizing Enterocolitis (Orphan designation)

Who Is Running the Clinical Trial?

Noveome Biotherapeutics, formerly Stemnion

Lead Sponsor

Trials

13

Recruited

430+

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Citations

1. noveome.com noveome.com/2024/11/14/noveome-biotherapeutics-inc-announces-completion-of-treatment-of-the-first-baby-in-its-phase-1-2-clinical-trial-evaluating-st266-in-the-treatment-of-necrotizing-enterocolitis-in-premature-infants/

14 November 2024 NEC-diagnosed babies in the treatment group will be treated with intravenously administered ST266 once daily for 10 days. Key endpoints are ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06315738?term=AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(Enterocolitis)%20AND%20AREA%5BOverallStatus%5D(RECRUITING))&rank=1

NCT06315738 | Study to Assess the Safety, Tolerability, ... An adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9448291/

The administration of amnion-derived multipotent cell ... The administration of amnion-derived multipotent cell secretome ST266 protects against necrotizing enterocolitis in mice and piglets.

4. noveome.com noveome.com/2023/12/12/noveome-biotherapeutics-inc-receives-fda-notification-to-proceed-with-its-phase-1-2-clinical-trial-in-treatment-of-nec/

Noveome Biotherapeutics, Inc. Receives FDA Notification ... Pre-clinical results suggest that ST266 may be effective in both preventing and treating Necrotizing Enterocolitis; first potential breakthrough therapy in ...

5. trial.medpath.com trial.medpath.com/clinical-trial/7dca63f885358eab/nct06315738-randomized-controlled-phase-1-2-study-st266-necrotizing-enterocolitis

Study to Assess the Safety, Tolerability, and Preliminary ... Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis ... Outcome data and publication updates.