Preterm neonates can develop chronic pulmonary insufficiency of prematurity (CPIP) later in infancy. Recombinant human CC10 protein (rhCC10) is an anti-inflammatory agent that could potentially prevent CPIP.
The safety and efficacy of a single intratracheal dose of rhCC10 in reducing CPIP at 12 months corrected gestational age (CGA) was evaluated in a Phase II double-blind, randomized, placebo-controlled, multisite clinical trial. Eighty-eight neonates were randomized: 22 to placebo and 22 to 1.5 mg/kg rhCC10 in the first cohort and 21 to placebo and 23 to 5 mg/kg rhCC10 in the second cohort. Neonates were followed to 12 months CGA.
With CPIP defined as signs/symptoms, medical visits, hospital readmissions, and use of medications for respiratory complications at 12 months CGA, no significant differences were observed between rhCC10 or placebo groups. Only 5% of neonates had no evidence of CPIP at 12 months CGA.
A single dose of rhCC10 was not effective in reducing CPIP at 12 CGA. Since most neonates had evidence of CPIP using these exploratory endpoints, it is essential to develop more robust outcome measures for clinical trials of respiratory medications in high-risk premature neonates.
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The authors wish to thank: (1) the members of the Data Safety Monitoring Committee, including Dr. Tamsin Knox (Chair), Dr. Steven Abman, Dr. John Kinsella, Dr. Martin Keszler, and Dr. Farzad Noubary; (2) Dr. Helen Christou and Dr. Sarbattama Sen for aid in subject recruitment; and (3) Dr. Morgan Newsome and Elyse Shenberger for technical assistance. This study was funded by an Orphan Product Grant (#FD-R-003899-01) to J.M.D. (Tufts Medical Center) from the Office of Orphan Product Development of the US Food and Drug Administration and the Clinical and Translational Science Award (UL1TR001064) from the National Center for Advancing Translational Science.