Company plans to evaluate octreotide product in a clinical bioequivalence study in Q4 2015
Glide Pharmaceutical Technologies, a UK company based in Abingdon, UK, focused on solid dose formulations of therapeutics and vaccines and non-invasive diagnostics, has reported the results from two separate studies using its novel solid dose injection system (SDI).
The first study, conducted in a surrogate model of human skin, confirmed the ability of the Glide SDI consistently to deliver a solid dose formulation. The second study confirmed the utility and ease-of-use of the system's design and operation in naïve human volunteers.
The human factor study followed progress in the company's device design optimisation programme, which is in the final development stage prior to manufacturing scale-up. The study, which enrolled 22 subjects with no prior experience of injection devices, aimed to assess the overall comfort and ease-of-use of the Glide SDI, and to identify any potential improvements in the design's utility. During the trial, the users scored the design highly in each of the usability tests undertaken, the company said.
The results from these two studies underpin our confidence in the performance of the Glide SDI system
In the skin delivery study, prototypes of the new Glide SDI design were used to deliver 100 placebo solid doses in an established in vivo model of human skin. The placebo formulation replicated the characteristics of Glide's novel octreotide product, which the company plans to evaluate in a clinical bioequivalence study with the currently marketed liquid product in the fourth quarter this year.
The delivery trial demonstrated that the Glide system achieved a 100% penetration rate into the skin and consistently delivered the solid formulation, the company said.
Dr Mark Carnegie-Brown, Glide's CEO, said: 'The results from these two studies underpin our confidence in the comfort, ease-of-use and performance of the Glide SDI system as we move towards human bioequivalence testing with our innovative octreotide product later in 2015.
'As we continue to progress our pipeline of novel therapeutics and vaccines, we are generating a substantial database showing that our Glide SDI system has the potential to become an important technology in an industry that is moving to more patient-focused and targeted products.'