Osteologix IND For NB S101 For Osteoporosis Accepted By FDA

Osteologix, Inc. (OLGX.OB), a specialty biopharmaceutical company, announced that the U. S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for its lead development candidate NB S101 (strontium malonate), for the treatment and prevention of osteoporosis. NB S101, a dual acting bone agent, has a demonstrated ability to decrease resorption of bone while maintaining formation of new bone. The drug has been formulated as a convenient once-daily tablet.


In September 2007, the company presented data from a Phase 1 study at the American Society for Bone and Mineral Research, demonstrating that NB S101 has superior bioavailability as compared to Protelos® (strontium ranelate), a strontium-based compound approved for sale in Europe and other territories outside the United States.


In November 2007, Osteologix announced significant results from its Phase 2 STRONG Study, demonstrating that NB S101 met its primary endpoint. At all doses tested, NB S101 demonstrated statistically significant decreases in CTX-1, a well-validated biomarker that measures bone resorption activity. When directly compared to the EU-approved strontium drug Protelos®, a 2 gram dose of NB S101 achieved significantly greater reductions of CTX-1 (p