According to records filed with the U.S. National Institutes of Health (NIH), InfaCare was conducting a Phase 2b for stannsoporfin with the primary goal of recorded favorable changes in adjusted total serum bilirubin (TSB) in newborns after 48 hours of treatment.
The trial had enrolled 63 infant patients since its inception in 2008, all diagnosed with hyperbilirubinemia – a condition in which there is too much of the pigment bilirubin in the blood.
The dangers of neonatal hyperbilirubinemia vary depending on the cause of the condition and the degree of elevation. In some cases, the condition can lead to an accumulation of bilirubin in the brain, leading to irreversible damage. Such damage may manifest itself as neurological defects, seizures, diminished reflexes and issues with eye movement.
According to documents filed with the U.S. Food and Drug Administration’s (FDA’s) Gastroenterology Drugs Advisory Committee, treatment with photosensitizing metalloporphyris (stannsoporfin) was associated with deaths in neonatal rats and skin rashes in human studies.
The FDA also noted concerns with the effects of the metal moiety found in compounds like stannsoporfin on long-term development and possible consequences related to the altering of the protective antioxidant effects of bilirubin.
Clinical research for the terminated stannsoporfin was conducted in the following cities: