Glide Pharma, the pharmaceutical development and device company focused on solid dose formulations of therapeutics and vaccines, today announced that its novel solid formulation of octreotide acetate achieved successful results in a pre-clinical proof-of-concept study comparing it with the currently marketed liquid product (Sandostatin®). Based on these results, the company intends to transfer the formulation production process to a contract manufacturing organisation (CMO), and to advance Glide octreotide delivered with the needle-free Glide solid dose injector (SDI®) into clinical trials in 2015.
The pre-clinical study compared the pharmacokinetic profile of the most widely used clinical dose of Sandostatin (100 mcg) with that of Glide’s octreotide solid dose formulation. The results demonstrated that there was no statistical difference between the two profiles (p<0.05). Octreotide products are currently approved for use in the treatment of acromegaly and certain neuroendocrine tumours with the market for immediate release liquid formulations estimated to be in excess of $150 million.
Dr Mark Carnegie-Brown, Glide Pharma’s CEO, commented, “These results represent a significant milestone, both in the development of our final clinical formulation for Glide octreotide and of our scale-up capabilities. Together, these enable us to transfer the formulation manufacturing process to a CMO later in the year. This progress is mirrored in our device scale-up programme, and as a result we plan to complete an octreotide clinical proof-of-concept study with our Glide SDI® device in 2015.”