NEC is an intestinal emergency that primarily affects premature infants. Intestinal tissue dies. In severe cases, mortality reaches 25–50 per cent. Around one in four affected infants needs surgery, which can leave a child with too little functional intestine to absorb food normally (short bowel syndrome).
It affects one to three per thousand live births, accounts for roughly nine per cent of all deaths in US neonatal intensive care, and has no approved drug treatment. Care is supportive: antibiotics, bowel rest, surgery.
BPD is a chronic lung disease of prematurity, affecting 10,000-15,000 US infants a year. Around 40 per cent of infants diagnosed with NEC also develop BPD. As with NEC, no therapy prevents or reverses the underlying alveolar injury.
We have completed funded preclinical studies at The Hospital for Sick Children (SickKids), Toronto, showing improvement in lung development metrics. BPD is our near-term second indication.
Our lead Secretomix® candidate is designed to interrupt the inflammatory cascade and support intestinal repair. In pre-clinical models conducted by third-party academic centres, it has produced a statistically significant reduction in lesion severity, histological evidence of tissue preservation, restoration of intestinal stem cell markers, and no adverse effects at therapeutic doses in non-GLP toxicology.
That data package supported a successful application to the MHRA’s Innovative Licensing and Access Pathway, the UK’s fast-track regulatory route. NEC qualifies as an orphan disease, and we are pursuing Orphan Drug Designation with the EMA and FDA.
Preclinical development is advanced. The programme is now at the point of manufacturing clinical-grade material, ahead of a Clinical Trial Application to the MHRA and a planned first-in-human Phase 1/2a trial in a UK neonatal intensive care setting. The initial trial is focused on NEC.