Biotech company, Shire, has been granted fast track designation by the US Food and Drug Administration (FDA) for SHP607, which is indicated for the prevention of chronic lung disease in extremely premature infants.
fast track
The fast track designation has been supported by preclinical data from Phase I and II trials. SHP607 is currently in Phase II clinical development and after discussions with regulatory bodies the company has decided to develop a Phase IIb/III clinical trial, in which the primary endpoint will be focused on chronic lung disease in extremely premature infants. Secondary endpoints will include bronchopulmonary dysplasia (BPD) and severe intraventricular haemorrhage (IVH).
“We are pleased to achieve this regulatory milestone as we progress this very important clinical development programme,” said Dr Howard Mayer, Shire’s head of research and development, ad interim. “There are no approved treatment options for chronic lung disease for premature infants, and we are aiming to change that. We are continuing to advance the SHP607 clinical programme, which is well aligned with Shire’s focus on bringing innovative therapies to patients with rare diseases worldwide.”
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 important in the development of the foetus in utero.