Zelos Therapeutics Ostabolin-CTM increases bone mineral density in Phase II trial

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Zelos Therapeutics Inc. announces top-line results from a Phase II study of its novel
parathyroid hormone (PTH) analogue, Ostabolin-C, in postmenopausal women with osteoporosis. Ostabolin-C is cyclic PTH (1-31), a proprietary PTH analogue that has demonstrated strong bone building activity in preclinical studies and is in late stage clinical development for the treatment of osteoporosis.

Ostabolin-C met the primary objective of this four month study by demonstrating a highly statistically significant, dose responsive increase in mean lumbar spine bone mineral density, that reached 5.2 per cent at the highest dose tested.

"We are greatly encouraged to see this impressive increase in bone mineral density after only four months of treatment with Ostabolin-C," said Brian MacDonald, MB, ChB, PhD, chief executive officer of Zelos.

"Ostabolin-C has the potential to be uniquely positioned among osteoporosis treatments as an agent that can rapidly increase bone mass. Bone building therapies such as this are increasingly needed for the large and growing number of people who have already lost large amounts of bone as a result of osteoporosis and are at high and imminent risk of sustaining a fracture," said MacDonald.

Ostabolin-C was generally well tolerated. The most common adverse events in the study were similar to those seen with other PTH analogs, namely nausea and headache. Mild hypercalcemia was observed at the highest dose tested, but at other doses that also demonstrated strong bone building activity, the incidence of hypercalcemia was similar to the placebo treated group. Additional results from the study have been submitted for presentation at an upcoming medical meeting.

Zelos is led by a team of seasoned biopharmaceutical executives and is based in West Conshohocken, PA and Ottawa, ON.