Life Sciences & Biotechnology

First-in-Class orally active fracture repairing drug candidate. Enhances osteoblast differentiation and mineralization at concentration as low as 1pM (EC50= 3.125 nM). Enhances new bone formation and restores bone microarchitecture in adult osteopenic rats. Enhances bone regeneration at fracture site at only 1 mg.kg-1.day-1 dose by stimulation of BMP/Smad signaling pathway . New bone formation at the fracture site is increased by ~40% in rats treated with S007-1500. S007-1500 enhances bone mineral density, new bone formation and bone biomechanical strength in ovariectomized osteopenic rat model. S007-1500 restores ovariectomized (Ovx) induced deterioration in bone microarchitecture. S007-1500 prevents Ovx induced increase in bone resorptive marker, CTx (a collagen breakdown product). S007-1500 prevents Ovx induced increase in bone turnover marker like serum OCN. Oral administration of S007-1500 at 1 mg/kg in rabbit critical size defect model led to almost complete bone healing at defect site as analyzed by radiography. S007-1500 is found safe in regulatory toxicity and safety pharmacology in GLP (rodents and non-rodents) as per Schedule “Y” and FDA guidelines.