A pediatric drug developer has raised $3.55 million — the first tranche of a $21.5 million series C Round to advance its drug to treat infantile jaundice or hyperbilirubinemia through a phase 2 clinical trial. It initiated recruitment for the trial earlier this year.
Among the investors in Trevose, Pennsylvania-based InfaCare are Longitude Capital, HealthCare Ventures, FirstMark Capital and Atlas Venture.
Jaundice in infants is caused by excess bilirubin levels in the blood, which yellows the skin and can be toxic to the brain. Bilirubin is formed from the breakdown of the heme component of hemoglobin in the blood. If bilirubin levels in the blood rise, it can cause brain dysfunction and ultimately brain damage.
InfaCare’s drug Stanate was licensed from Rockefeller University. A heme oxygenase inhibitor, Stanate prevents the breakdown of heme in the body. It is designed to significantly reduce the body’s production of bilirubin over a six- to eight-day period through an intramuscular injection.
Infantile jaundice is typically treated with phototherapy to reduce bilirubin levels. The light, absorbed by the skin, converts bilirubin to a less-toxic, water-soluble form that’s flushed out of the body through urine.
But in a phone interview with MedCity News, InfaCare CEO Dan Burns said phototherapy comes with its own set of problems. It interrupts the bonding process between an infant and the parents, and more importantly, disrupts breastfeeding, which is critical to reducing the likelihood of health problems and means additional hospitalization costs. Burns pointed out that raised bilirubin levels were the No. 1 cause of infant readmissions. Although phototherapy reduces bilirubin levels, it doesn’t stop production, said Burns, and levels can rise back up. And if phototherapy doesn’t work, the alternative is an exchange transfusion, a procedure in which the red blood cells are removed and replaced with transfused blood products and would pose serious risk to a newborn.
Burns said about 1,500 infants to date had been treated with Stanate. About 60 percent of newborns and 80 percent of premature babies develop jaundice, according to Robert Wood Johnson Hospital’s website. Infants of diabetic mothers and of mothers with Rh disease are more likely to develop hyperbilirubinemia and jaundice.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“We have treated a lot of patients with this drug and are extremely confident in the drug. It shows efficacy in every patient who has received it.”
