SMR-3753 (phospholipid DHA) as a new drug to prevent neurodevelopmental complications of extreme prematurity.

Extremely premature infants are those that are born before week 28 in pregnancy; known to have a high risk of mortality and morbidity, especially severe neurodevelopmental disabilities such as intellectual disability, cerebral palsy, and intraventricular haemorrhage. Extreme ‘premis’ are born with deficiency in DHA, an essential fatty acid, which in full-lengthy pregnancies would have contributed to normal brain and retina maturation. We are developing the drug candidate SMR-3753 as an emulsion for parenteral tube feeding of phospholipid-enriched DHA, due to its marine origin (herring roe extract), with the objective of reduce and/or prevent severe brain-related complications. The project itself aims to include some 5-7 partners in total, two Norwegian SMEs and 3-5 academic institutions including university hospitals with neonatology intensive care units experienced in clinical intervention trials. At present, we assume that the project will embed 6 work packages: (1) Project Management, (2) Regulatory Affairs, (3) Manufacturing Development and Upscaling, (4) Pre-clinical modelling and development, (5) Clinical trial(s); and (6) Market Access and Commercialisation. The project will span some 4-5 years, with an overall budget of 8,000,000 EUR.