Osteoporosis is the most prevalent metabolic bone disease characterized by low bone mass and microarchitectural deterioration of bone, leading to enhanced bone fragility and a consequent increase in fracture risk. At the present time, most available t...
Osteoporosis is the most prevalent metabolic bone disease characterized by low bone mass and microarchitectural deterioration of bone, leading to enhanced bone fragility and a consequent increase in fracture risk. At the present time, most available therapies for osteoporosis inhibit osteoclastic bone resorption(estrogen, calcitonin, bisphosphonates etc.).
OSCOTEC Inc. is a bone-specialized bioengineering company aiming to develop new drugs for osteoporosis and arthritis. OSCOTEC Inc. has several pipelines for development of new drug candidates for osteoporosis.
Among these pipelines OCT-1547, the first candidate molecule(oral anti-resorbing drug candidate), was selected after following experiments: in vitro efficacy test, in vitro permeability & metabolic stability test, in vivo pharmacokinetic profile and in vivo efficacy test, single- and repeat-dose toxicity test, CYP inhibition/induction test and metabolite identification, mode of action study etc.
The preclinical trial was performed in UK to determine the general toxicity(single dose toxicity in rats and mice and repeat dose toxicity in rats and dogs), genetic toxicity and safety pharmacology.
Overall, the available data support the administration of OCT-1547 to the Phase 1 clinical trial. The first study in man will be initiated after IND filing to FDA.