Glide Technologies, the development company focused on solid dose formulations of therapeutics and vaccines and non-invasive diagnostics, today 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 $1.3 billion.
Dr Mark Carnegie-Brown, Glide’s CEO, commented, “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.”