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news.InfaCare Pharmaceutical has completed enrolment in its Phase IIB Jasmine study, a Multicenter, Single Dose, Randomized, Double Blind, Placebo Controlled, Parallel Group Study Evaluating the Safety and Efficacy of Two Doses of Stannsoporfin in Conjunction with Phototherapy in Neonates, versus Phototherapy alone.
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Stannsoporfin is a first in class heme oxygenase inhibitor that inhibits the formation of bilirubin and is in development for the treatment of hyperbilirubinemia in newborns.
The study enrolled 91 term and near term newborns of 35 weeks gestational age and older, across 20 centers in the USA. The neonates had blood type incompatibilities with their mothers, had evidence of hemolysis (breakdown of red blood cells) and bilirubin levels requiring intervention in accordance with American Academy of Pediatrics (AAP) guidelines.
Neonates were randomized in a blinded fashion to receive 4.5 mg/kg or 3.0 mg/kg of stannsoporfin or placebo in a single intramuscular injection. All participants received phototherapy (PT) according to the most current guidelines.
Bilirubin levels were followed every six hours until PT could be stopped according to the AAP guidelines. The primary efficacy endpoint of the study is the comparison in percent change in bilirubin from baseline at 48 hours for each dose compared to placebo.
Currently there are no commercially available drug therapies that inhibit the formation of bilirubin. Phototherapy and exchange blood transfusion are used when levels of bilirubin have already risen to a point of clinical concern, or beyond to more serious levels.
Very high levels of bilirubin can result in various developmental and neurologic defects, including severe forms of cerebral palsy, and kernicterus which can lead to permanent brain damage or death.
Stannsoporfin is in clinical development for the treatment of neonatal hyperbilirubinemia. Several studies have been completed in term, near term, and premature neonates, and those at risk of requiring exchange blood transfusion. Preliminary data suggest that stannsoporfin has the potential to decrease or prevent the need for phototherapy and exchange transfusion.
"Stannsoporfin represents the first therapy that targets the production of bilirubin and, if determined to be safe and efficacious by the FDA, will be the first new treatment for neonatal hyperbilirubinemia in more than 50 years," said Dr. Nancy M. Ruiz, Chief Medical Officer of InfaCare.
"We are pleased to have completed this important milestone in the study of stannsoporfin, the only pharmacological agent currently in clinical development designed to inhibit bilirubin production and prevent bilirubin from reaching dangerous levels in neonates with indicators of hemolysis.
"Stannsoporfin has the potential to reduce or prevent the risk of the devastating neurological outcomes associated with uncontrolled hyperbilirubinemia," said Dan Burns, President and CEO of InfaCare.