To evaluate the efficacy and safety of tin mesoporphyrin (SnMP) in neonates with hyperbilirubinemia (HB) due to hemolysis.
This multicenter, placebo-controlled phase 2b study (NCT01887327) randomized newborns (35–42 weeks) with hemolysis started on phototherapy (PT) to placebo (Ctrl), SnMP 3.0 mg/kg, or SnMP 4.5 mg/kg given once IM within 30 min of initiation of PT.
In all, 91 patients were randomized (Ctrl: n = 30; 3 mg/kg SnMP: n = 30; 4.5 mg/kg SnMP: n = 31). At 48 h TSB significantly increased in Ctrl by 17.5% (95% CI 5.6–30.7; p = 0.004) and significantly decreased by −13% (95% CI −21.7 to −3.2; p = 0.013) in the 3.0 mg/kg and by −10.5% (95% CI −19.4 to −0.6; p = 0.041) in the 4.5 mg/kg group. Decreases in SnMP groups were significant (p < 0.0001) vs Ctrl.
SnMP with PT significantly reduced TSB by 48 h. SnMP may be useful as a treatment for HB in neonates with hemolysis.
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Infacare Pharmaceuticals designed this study to meet Phase 2B requirements of the FDA. They chose clinical sites, provided study oversight, and collected data. They were not involved in the manuscript preparation but have reviewed the manuscript. Data for this article were collected by Infacare but were analyzed independently by the authors.
Conflict of interest
The authors declare no competing interests.
Ethics approval and consent to participate
The study protocol, amendments, and informed consent forms were reviewed and approved by the Institutional Review Boards at each study site. This study was performed in accordance with the Declaration of Helsinki.
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Rosenfeld, W.N., Hudak, M.L., Ruiz, N. et al. Stannsoporfin with phototherapy to treat hyperbilirubinemia in newborn hemolytic disease. J Perinatol 42, 110–115 (2022). https://doi.org/10.1038/s41372-021-01223-2