Glide begins solid dose, injectable acromegaly drug trial on birthday of most famous sufferer
The trial is designed to compare the pharmacokinetic profile and bioavailability of Glide’s version of octreotide acetate with the reference product, an injectable drug called Sandostatin that is sold by Swiss drug firm Novartis.
The Glide product is a solid dose pellet - around 4mm long by 0.8mm wide – that is injected through the skin using an injector supplied by Nypro.
A spokesman told us “The technology is novel and proprietary to Glide, which is advancing the development programme in house.”
The drug itself is produced by Albany Molecular Research (AMRI), which installed a dedicated clinical production line at its sterile manufacturing facility in Glasgow, Scotland last year.
The Glide spokesman told us the trial is being conducted on its behalf by a UK-based contract research organisation called BKE. He added that the plan is to enrol 20 acromegaly patients and complete the research before the end of the year.
Andre the Giant
Acromegaly is a condition in which the pituitary gland produces excess growth hormone (GH) which causes giagantism, severe disfigurement and fatal complications if untreated. It affects 40 - 60 million people worldwide.
Wrestler André the Giant - André René Roussimoff - one of the most famous acromegaly sufferers, would have been 70 years old today.
In addition to being used to treat acromegaly, octreotide is approved for certain neuroendocrine tumours. Glide estimates that the global market for immediate release liquid formulations is worth more than $150m (€134m).
The start of the Glide study follows just a few weeks after the US Food and Drug Administration (FDA) rejected an oral version of octreotide called Mycapssa developed by Massachusetts-based Chiasma.
