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news.Biopharma company Zelos Therapeutics has completed patient enrollment in its phase II clinical trial for Ostabolin-C, its drug candidate for the treatment of osteoporosis.
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Ostabolin-C is a next-generation PTH analog for the treatment of osteoporosis. Zelos began a multi-center phase II clinical trial for Ostabolin-C injection in May 2005 that has enrolled 261 post-menopausal women with low bone mineral density.
The trial is a placebo-controlled, double blind, dose finding study. Subjects randomized into the study receive daily injections of one of four doses of Ostabolin-C or placebo for up to twelve months. Zelos previously completed three phase I trials involving approximately 100 patients. The company also has Ostabolin-C gel in phase II for the topical treatment of psoriasis.
“We anticipate that the lack of bone resorption associated with this compound in preclinical studies, combined with a strong stimulation of bone formation will deliver greater bone-strengthening benefit than has been reported for other drugs in this class. At the same time, the lack of bone resorption may reduce the incidence and severity of hypercalcemia, which is a common side effect of PTH therapy,” said Dr Brian MacDonald, CEO of Zelos.