Shire says Phase II trial for rare eye condition in premature infants fails
pharmafile | July 1, 2016 | News story | Medical Communications, Research and Development | Shire, US FDA, drug trial, rare eye condition in infants
Shire plc (LSE: SHP) said its drug compound to treat a rare eye condition in infants failed mid-stage trials.
The company said the trial drug, SHP607, however, met the secondary endpoints in a chronic lung disease, and a type of brain injury, both of which have lifelong negative implications for normal development.
Philip Vickers, head of research & development, Shire, 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.”
SHP607 is a recombinant human version of the naturally-occurring protein complex of insulin-like growth factor 1 (IGF-1) and its most abundant binding protein, IGF binding protein-3 (IGFBP-3). IGF-1 is a growth factor that plays a major role in the development of the growing fetus in the uterus. It is supplied by the mother until about 30 weeks of gestation when the fetus begins producing the growth factor on its own. Levels of IGF-1 dramatically decrease in infants born extremely premature (before 28 weeks of gestation), thereby increasing the risk for complications related to the lungs, brain, eyes, and other organs.
Professor Neil Marlow one of the clinical trial investigators, said: “This is the first controlled clinical trial to confirm the crucial role of IGF-1 in maturation of extremely preterm children. The reduction in BPD and IVH, as the two most important morbidities suffered by these children, are welcoming and a first in neonatal medicine. It will be important to confirm these findings in additional clinical studies.”
The Phase II study included 121 extremely premature infants (born between 23 weeks and 27 weeks +6 days) randomized at birth to either SHP607 or standard neonatal care, and treated continuously until an equivalent gestational age of 30 weeks.
Shire expects to begin discussions with regulatory authorities later this year about a Phase III clinical program, the company said in a statement.
Anjali Shukla
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