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SHP607 reduces BPD, IVH among premature infants in phase 2 trial
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SHP607, a recombinant human version of insulin-like growth factor 1 and IGF binding protein-3 from Shire, effectively reduced development of severe bronchopulmonary dysplasia and severe intraventricular hemorrhage among extremely preterm infants, according to recent phase 2 findings.
The investigational protein replacement, however, did not meet its primary endpoint of effectively reducing the severity of retinopathy, a rare eye condition that occurs in extremely preterm neonates. The secondary endpoints, of reducing bronchopulmonary dysplasia (BPD) and intraventricular hemorrhage (IVH), were met successfully in the multicenter trial.
“This is the first controlled clinical trial to confirm the crucial role of IGF-1 in maturation of extremely preterm children,” Neil Marlow, MD, of University College London Hospitals, said in the release. “The reduction in BPD and IVH, as the two most important morbidities suffered by these children, is welcoming and a first in neonatal medicine. It will be important to confirm these findings in additional clinical studies.”
The researchers studied 121 extremely preterm infants born between 23 weeks’ and 27 weeks plus 6 days’ gestational age. The patients at birth were randomly assigned standard neonatal care or a 250 µg/kg daily 24-hour infusion of SHP607. Infants were treated until they reached the equivalent of 30 weeks’ gestational age.
Patients in the SHP607 group had a 53% reduction in severe BPD incidence, compared with the untreated infants. Likewise, researchers found a 44% reduction in incidence of severe IVH among treated infants. The investigators said among the patients who achieved the prespecified target drug exposure, there was an 89% reduction in BPD and a 64% reduction in IVH.
“Although the study did not meet its primary endpoint, we are extremely encouraged by the top-line secondary endpoints related to lung and brain,” Philip J. Vickers, PhD, head of research and development at Shire, said in the release. “These data support our commitment to further investigate the potential systemic benefits of SHP607 in this population where the unmet patient need is substantial.”