Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.A phase 2 clinical trial assessing Shire’s investigational protein replacement, SHP607, failed to meet its primary endpoint of reducing the severity of retinopathy of prematurity (ROP), a rare eye condition.
Subscribe to our email newsletter
The phase 2 study included 121 extremely premature infants born before 28 weeks’ gestation who were randomized to receive SHP607 or standard neonatal care and were treated until an equivalent gestational age of 30 weeks.
The study demonstarted clinically relevant effects in secondary endpoints associated to severe bronchopulmonary dysplasia (BPD) (a chronic lung disease) and severe intraventricular hemorrhage (IVH) (type of brain injury).
Results demonstrated a 53% reduction in the incidence of severe BPD and an 89% reduction in those infants who achieved a prespecified target of drug exposure.
The incidence of severe IVH was reduced 44% in all assessed patients that received SHP607, as compared to untreated infants.
Another secondary endpoint, time to discharge from neonatal intensive care, was also not met.
SHP607 is a recombinant human biologic protein complex of insulin-like growth factor-1 (IGF-1) and its principal binding protein, IGF binding protein 3 (IGFBP3) [rhIGF-1/rhIGFBP-3].
Shire head of research & development Philip Vickers 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."
Shire plans to discuss a phase 3 program in clinically relevant complications of prematurity with regulators later this year.