Shire drug tests shows first ever effects on reducing prenatal complications

The drug, currently called SHP607 helped reduce the occurrence of severe bronchopulmonary dysplasia (BPD) and severe intraventricular hemorrhage (IVH).

Shire said it expects to begin discussions with regulators later this year about a Phase III clinical program focusing on clinically relevant complications of prematurity.

BPD and IVH are the two most important morbidities suffered by premature children, said Professor Neil Marlow, lead clinical trial investigator at University College London Hospital, and the reductions shown by the protein replacement therapy were "a first in neonatal medicine".

Philip Vickers, Shire's head of research and development, said: “Although the study did not meet its primary endpoint, we are extremely encouraged by the topline secondary endpoints related to lung and brain.

"For severe complications related to the lung and brain, there are no approved treatment options, and these data support our commitment to further investigate the potential systemic benefits of SHP607 in this population where the unmet patient need is substantial.”