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-- By Brian Gormley --
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9/20/2007 - West Conshohocken, Pa.
Osteoporosis-drug company Zelos Therapeutics Inc. has generated strong Phase II data for a bone-building agent that could challenge a blockbuster drug sold by Eli Lilly & Co.
The West Conshohocken, Pa., company said that Ostabolin-C increased bone density and that its effects were durable through the 12 months of the study. The company expects to enter Phase III in the first half of 2008 and is talking with the U.S. Food and Drug Administration about trial design, said Chief Business Officer Jay Mohr.
Zelos, which has raised $58.5 million from a group of investors that includes Alta Partners, Prospect Venture Partners, Frazier Healthcare Ventures and Seaflower Ventures, is considering whether to take Ostabolin-C into Phase III on its own or with a corporate partner, Mohr said. It's also weighing its funding options, which include raising a third venture round or going public. Zelos raised its last round, a $45 million Series B, in May 2005.
Some 10 million Americans - 80% of them women - have osteoporosis, according to the National Osteoporosis Foundation. The disease, whose hallmarks include low bone mass and bone deterioration, increases risk of fractures, especially in the hip, spine and wrists.
A variety of drugs, such as Merck & Co.'s Fosamax, can reduce bone loss, but only one, Eli Lilly's Forteo, stimulates bone formation. Forteo, approved in the U.S. in November 2002, is a portion of human parathyroid hormone, a primary regulator of calcium and phosphate metabolism in bones. Forteo, injected daily, is on pace to surpass the $594.3 million in sales it drew in 2006. In July, Lilly said first-half sales totaled $330.6 million, up 21% from the same period last year.
Zelos' Ostabolin-C would give patients another bone-building, or anabolic, option. The drug, injected subcutaneously, also is a portion of parathyroid hormone. But Ostabolin-C consists of amino acids one to 31, while Forteo is made up of amino acids one to 34.
The initial Phase II study evaluated the safety and effectiveness of four months of treatment with Ostabolin-C in 261 post-menopausal women aged 45 to 75 with low bone mass. One hundred ninety-eight of the subjects then continued into an eight-month blinded extension study.
The study achieved its primary endpoint, with a significant change in lumbar-spine bone-mineral density at one year for all treatment groups, the company said. Significant increases in bone-mineral density of the hip were also observed, according to the company. Mohr said Zelos' data suggest the drug is well-tolerated.
Zelos has also seen positive Phase I results for an inhaled version of Ostabolin-C that it's developing with publicly traded Nektar Therapeutics. The Phase I study of healthy post-menopausal women demonstrated the ability of inhaled Ostabolin-C to increase serum markers of bone formation to levels comparable with the effect of subcutaneous injections of the drug at a similar time point, the company said. The treatment duration in this trial was 28 days.
http://www.zelostherapeutics.com
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