Glide Technologies, the development company focused on solid dose formulations of therapeutics and vaccines and non-invasive diagnostics, announced that its novel solid dose formulation of teriparatide (parathyroid hormone) achieved successful results in a pre-clinical proof-of-concept study comparing it with the currently marketed liquid product (Forteo/Forsteo).
Based on these results, the company intends to transfer the formulation production process to a contract manufacturing organisation in the coming months, and to advance Glide teriparatide delivered with the company's needle-free solid dose injector (teriparatide SDI) into clinical trials in 2016.
The pre-clinical study compared the pharmacokinetic profile of the most widely used clinical dose of teriparatide (20 mcg) with that of Glide's solid dose formulation delivered using the company's SDI. The results demonstrated that there was no statistical difference between the two profiles (p<0.05). Teriparatide is currently approved for use in the treatment of osteoporosis with 2014 sales in excess of USD 1.3 billion.
Dr Mark Carnegie-Brown, Glide's chief executive officer, said "These results follow positive equivalence data with octreotide SDI, and demonstrate the flexibility of the Glide SDI platform in delivering therapeutic peptides. We believe that the Glide SDI will have particular advantages with self-administered treatments, such as teriparatide and octreotide, and we are expanding our pipeline to encompass additional therapeutic areas where patient-focused products are key, such as diabetes."