Introduction to Infantile Hyperbilirubinemia

Neonatal jaundice, or hyperbilirubinemia ("HB"), is the abnormal elevation of bilirubin in newborns. Bilirubin is a pigmented naturally occurring chemical formed from the breakdown of hemoglobin in the body. Bilirubin is normally modified by the liver and eliminated from the body, but in neonates, the liver is still maturing and may not be able to eliminate the bilirubin adequately, especially if the rate of production is increased, for example in the case of excessive red cell breakdown (hemolysis) which occurs in a proportion of neonates.

Bilirubin levels increase after birth, generally peaking 3 to 5 days post-natal. Severe HB, if not properly treated, can lead to neurological damage, the most devastating of which is a form of cerebral palsy known as kernicterus. Jaundice, or a yellow coloring caused by raised levels of bilirubin occurs in up to 60% of newborns. Up to 15% of all newborns will develop serum bilirubin levels putting them in a ‘high risk' category requiring intervention while thousands more at medium risk may also require treatment. Fortunately, HB is easily diagnosed with a blood test, and current guidelines from the American Academy of Pediatrics promote universal screening and aggressive follow-up and treatment.

The standard treatment for HB today is phototherapy, which is the use of ultraviolet light directly on the neonate's skin to increase the breakdown of bilirubin, which the infant's liver cannot yet adequately perform. Phototherapy typically delays the newborn's hospital discharge from 3 to 5 days, results in separation from the mother and may interfere with breast feeding. In the cases where phototherapy does not adequately reduce bilirubin, an exchange transfusion of the baby's blood is performed. However, this procedure has significant morbidity and mortality risks. In recent years physicians have been increasing the intensity of phototherapy, for example by adding additional banks of lights, in order to avoid resorting to exchange transfusion. At the same time, new clinical data suggest that the use of this intensive phototherapy may have its own increased morbidity and mortality risks.

InfaCare is developing Stanate^® as the first pharmacological treatment for HB. It will be the first treatment that will inhibit the formation of bilirubin by inhibiting production.

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