Glide Technologies, the development company focused on solid dose formulations of therapeutics and vaccines and non-invasive diagnostics, today announced successful results from two separate studies using its novel solid dose injection system (SDI). The first study, conducted in a well-established surrogate model of human skin, confirmed the ability of the Glide SDI® to consistently 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 follows strong progress in the company’s device design optimisation programme, which is the final development stage prior to manufacturing scale-up. The study, which enrolled 22 subjects with no prior experience of injection devices, was designed 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 subjects rated their experience, and the results show that users scored the design highly in each of the usability tests undertaken.
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 was designed to replicate 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 Q4 2015. The results of the delivery trial demonstrate that the Glide system successfully achieved a 100% penetration rate into the skin and consistently delivered the solid formulation.
Dr Mark Carnegie-Brown, Glide’s CEO, commented, “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.”