Micregen

Clinical target
Lead Clinical Target

Micregen has strategically chosen to focus its lead therapeutic development on two rare neonatal diseases with critical unmet need, Necrotising Enterocolitis (NEC) and Bronchopulmonary Dysplasia (BPD). The biology underpinning NEC reveals profound overlap with core mechanisms that underlie a broad spectrum of degenerative and age-associated adult diseases and that may be conducive of treatment with a stem cell secretome based therapy.

NEC and similar neonatal conditions are marked by molecular and cellular failures such as:

  • Dysfunction and depletion of resident stem cell populations
  • Accumulation of senescent (nonfunctional, aging or damaged) cells within tissues
  • Ongoing cell necrosis and impaired regenerative capacity
  • Chronic and uncontrolled inflammation disrupting tissue repair
  • Impaired autophagy, leading to build-up of damaged cellular components
  • Elevated oxidative damage, further compromising tissue integrity

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.

These pathological themes are not unique to NEC and BPD, they are recognised hallmarks of many chronic adult diseases, ranging from organ fibrosis and neurodegeneration to metabolic conditions. By selecting NEC as a first-in-human indication, Micregen can directly address a devastating, high-urgency neonatal disorder while establishing their lead secretome candidate’s efficacy in targeting these foundational disease mechanisms.
Micregen’s secretome products have been tested, with encouraging results in pre-clinical studies of NEC and BPD in Micregen’s laboratories and by academic collaborators and third-party CROs in the USA, UK and Canada.
Necrotising Enterocolitis

Necrotising Enterocolitis (NEC) is a severe gastrointestinal disease that predominantly affects premature, low birth weight infants. It is classified as an orphan disease and remains a significant cause of morbidity and mortality in neonatal intensive care. The incidence is estimated at 1–3 per 1,000 live births, with more than 90% of cases occurring in preterm infants. Risk is highest in the smallest and most premature babies often weighing 1,500g and below at birth.

Despite advances in neonatal care, NEC-related mortality can still reach 50%. Approximately one in four affected infants require surgical intervention, with around 20% of these surgical cases resulting in death before 28 days of age and a further quarter developing serious complications. Surgery can lead to life-altering sequelae such as Short Bowel Syndrome, contributing to long-term nutritional and developmental challenges.

At present, there is no effective pharmacological treatment for NEC, management is largely supportive, focusing on infection control, nutritional support, and surgery when intestinal necrosis or perforation occurs. This lack of targeted therapy underlines the urgent clinical need for innovative, disease-modifying interventions.

Micregen’s lead Secretomix® therapeutic candidate MRG1061 is designed to address this gap. By delivering a tailored combination of regenerative and anti-inflammatory factors, MRG1061 aims to reduce intestinal injury, promote healing, and improve survival outcomes in NEC, offering a potentially transformative advance in the management of this devastating neonatal condition.

Bronchopulmonary Dysplasia

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.

Bronchopulmonary dysplasia (BPD) is a complex, multifactorial lung disease that almost exclusively affects preterm infants. It is characterised by immature, underdeveloped lungs that are highly susceptible to inflammation, infection, and injury caused by the initially life-saving respiratory supportive interventions such as oxygen therapy and mechanical ventilation. BPD frequently co-presents with other serious conditions; notably, around 40% of infants diagnosed with Necrotising Enterocolitis (NEC) also develop BPD.

BPD remains a significant cause of morbidity and mortality extending well beyond childhood. Each year, between 10,000 and 15,000 newborns develop BPD in the U.S. alone (Jensen & Schmidt, 2014, Thomas et al., 2022). The disease not only impacts respiratory health in the neonatal period but is also associated with chronic lung dysfunction, impaired growth, and increased risk of long-term health complications. Current treatment strategies are primarily supportive, focusing on minimising further lung damage by controlling inflammation within developing alveoli and alveolar capillaries. Despite advances in neonatal intensive care, no effective therapy exists to prevent or reverse the alveolar injury central to BPD’s pathogenesis. Secretomix® administration is expected to address this unmet clinical need by reducing alveolar injury and promoting repair, ultimately aiming to improve both survival and long-term outcomes for infants affected by BPD.
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