Date: 2015-04-23
Type of information: Results
phase: preclinical
Announcement: results
Company: Glide Technologies (UK)
Product: solid dose formulation of teriparatide (parathyroid hormone)
Action
mechanism: peptide/parathyroid hormone related peptide. Parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney.Teriparatide is an active fragment of PTH. Its actions include stimulation of bone formation by direct effects on osteoblasts indirectly increasing the intestinal absorption of calcium and increasing the tubular re-absorption of calcium and excretion of phosphate by the kidney.
Disease: osteoporosis
Therapeutic area: Bone diseases
Country:
Trial details:
Latest
news: * On April 23, 2015, Glide Technologies, a 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 $1.3 billion.
