Osteologix, Inc (SAN FRANCISCO, California), a specialty biopharmaceutical company targeting musculoskeletal diseases, announced that the US FDA has accepted its investigational new drug (IND) application for its lead development candidate NB S101 (strontium malonate) to treat and prevent 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 reported data from a phase I study demonstrating that the agent has superior bioavailability compared with Protelos^® (strontium ranelate), a compound approved for sale in Europe and other territories outside the US.

In November 2007, Osteologix announced results from its international, randomized, double-blind, active-controlled phase II dose-response STRONG study, demonstrating that NB S101 met its primary endpoint. At all doses tested, the agent demonstrated statistically significant decreases in CTX-1 (C-terminal telopeptide of type 1 collagen), a well-validated biomarker that measures bone resorption activity. NB S101 2 g achieved significantly greater reductions of CTX-1 compared with Protelos 2 g (P<.001). In addition, all dose groups demonstrated significant increases in bone mineral density at 12 weeks.

In April 2008, the company completed a $5.3 million private placement financing with two accredited investors and plans to use the proceeds for general corporate purposes including development of NB S101. The clinical areas being investigated all comprise disorders where bone and cartilage metabolism is affected, including osteoporosis, osteoarthritis, metastatic bone disease, hyperparathyroidism-associated bone disease, secondary osteoporosis, and renal disease.