InfanDx and LSI have announced that they have obtained the positive vote of the relevant ethical committee to start the first clinical study on short notice. This study called AAMBI (Asphyxia Associated Metabolite Biomarker Investigation) is designed as verification study. It aims to confirm in human the metabolite biomarker combinations obtained from previous animal studies. The asphyxia test under development will be the first to early and reliably diagnose brain damage caused by perinatal asphyxia, i.e. oxygen deficit during birth.
“This ethics vote and our existing partner clinics featuring sufficient annual case numbers now enable us to take this most meaningful step in our recent company history” Ron Meyer, InfanDx’ CEO happily states. Throughout the upcoming six months early postnatal blood samples shall be taken from 80 newborns suffering from moderate to severe neonatal encephalopathy (NE/ brain damage) plus healthy controls. After completion of recruitment results of metabolomics testing of these samples will be compared with the clinically diagnosed status of the children.
The concept of the deferred and clinically disconnected analytics allows to already now plan for the next large validation study for which recruitment and sampling shall be run partly parallel to AAMBI study and which is designed to serve for performance evaluation. “If things go well, InfanDx will deliver a wonderful Christmas present to us as the conclusion of this study will mark a significant leverage in corporate valuation” assumes Dr. Jörg Fregien, CEO of LSI, which currently incubates InfanDx.
Perinatal asphyxia may occur before, during or after delivery. While it is extremely difficult to diagnose asphyxia with newborns immediately after birth still about 40% of babies who suffered brain damage are not identified early enough. This situation is especially frustrating as most of these children could be helped through therapeutic hypothermia, a controlled cooling therapy that critically needs to be started earliest possible within the first 6 hours after birth.
Only in this short therapeutic time window this treatment has proven to be effective and to avoid lifelong disabilities such as cerebral palsy/spasticism, blindness and other forms of neurological impairments. Worldwide and each year >1 mio. babies suffer from NE, which makes it within the delivery period the largest single cause for lifelong morbidity. The biomarkers developed by the InfanDx-project will be the first diagnostic tool to reliably identify the babies in need early enough.