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New Osteoporosis Drug in First Human Study

Compound that protected against bone loss in monkeys is well-tolerated in humans

WEDNESDAY, Sept. 28 (HealthDay News) -- An experimental osteoporosis compound called AAE581 appears to be well-tolerated, according to results from the first human study of the drug presented at the annual meeting of the American Society for Bone and Mineral Research (ASBMR) in Nashville, Tenn.

Sandip K. Roy, Ph.D., and colleagues at Novartis in East Hanover, N.J. and Basel, Switzerland, tested the effects of AAE581, a cathepsin K-inhibitor, on 32 healthy men and women aged 18 to 45. Twelve participants received a placebo.

The drug was well-tolerated, and six to 12 hours after taking a 25 mg or greater dose of AAE581, patients' serum biomarker levels indicated that bone breakdown fell by 90%.

In another study released at the meeting, Christopher P. Jerome, Ph.D., and colleagues at SkeleTech in Bothell, Wash., in conjunction with Novartis researchers, found that AAE581 protected against bone loss in a monkey model of osteoporosis.

"These data in a non-human primate model are exciting because they suggest that this is another potential therapy for osteoporosis with novel and divergent effects on bone resorption (which was decreased) and bone formation (which was increased)," said ASBMR president-elect Elizabeth Shane, M.D., in a statement.

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