Ageing per se is not recognised as a disease for regulatory approval purposes, and few individual diseases address multiple aspects of ageing. Necrotizing Enterocolitis (NEC) has been chosen as Micregen’s first clinical target, due to the degenerative nature of the condition, the desperate need for effective treatment and the opportunity to demonstrate tissue repair. NEC also addresses many root causes of ageing, and the disease qualifies for fast-track regulatory approval and should enjoy associated orphan disease designation benefits.
Root causes of Ageing associated with NEC:
- Failure of resident stem cell populations
- Senescent cell accumulation
- Failure of Autophagy
- Oxidative damage
NEC is a devastating inflammatory bowel disease of infants marked by necrosis. It is the most common gastrointestinal emergency in preterm neonates and a significant cause of morbidity and mortality in neonatal intensive care units worldwide.
The incidence of NEC is estimated to be 1–3 per 1000 live births, with more than 90% of all cases occurring in preterm infants. Research has shown NEC was recorded in 11.5%, 9%, 6%, and 4% of infants weighing 401–750g, 751–1000g, 1001–1250g, and 1251–1500g, respectively. Despite improvements in neonatal intensive care and increased overall survival of critically ill premature neonates, mortality rates from NEC can still reach 50% (Stoll, Hansen et al. 2010, Neu and Walker 2011).
The principal modes of action of Secretomix® in NEC are believed to be through:
- Modulation of inflammation
- Decreased cellular senescence
- Activation of resident stem cell and tissue-specific progenitor cell populations.
- Improved angiogenesis – enhanced blood flow
- Anti-apoptotic and chemotactic signalling
- Beneficial remodelling of the extracellular matrix
Micregen’s secretome products have been tested, with encouraging results in pre-clinical studies of NEC in the USA, UK, and Canada in Micregen’s laboratories, with academic collaborators and third-party CRO.
In process assays, potency assays, and release assays are complete, and the manufacturing contract is also complete to start the tech transfer to contract manufacturers.
Further pre-clinical research is being undertaken to establish the most appropriate Secretomix® to manufacture clinical material for Micregen’s initial human clinical trial.