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

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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