It's the TOPs

NPS Pharmaceuticals, from Salt Lake City, US, has said that its pivotal Phase III study of PREOS successfully met the primary endpoint of reducing the incidence of new or worsened vertebral fractures in postmenopausal women with mild to moderate osteoporosis, and that the company is proceeding with plans to submit an application later this year to the FDA for approval to market the drug.

PREOS is recombinant human parathyroid hormone (PTH), which has been shown in previous human studies and animal tests to stimulate bone turn-over processes, resulting in a net increase in healthy, fracture-resistant bone.

The PREOS Phase III study, known as TOP (Treatment of Osteoporosis with PTH), was a multi-centre, randomised, double-blind, placebo-controlled clinical trial designed to evaluate the potential of PTH to reduce the risk of vertebral fracture in women who represent a broad population of osteoporosis patients.

The primary endpoint in the TOP study was a reduction in the incidence of new or worsened vertebral fractures in patients receiving PREOS, compared with patients who received a placebo.

An analysis of all patients receiving at least one dose of PREOS or placebo showed a statistically significant (p-value = 0.001) reduction in the relative risk of vertebral fractures for patients in the treatment group, compared with the placebo group.

Dr Alan Rauch, chief medical officer at NPS, said: 'We are very pleased with the results of the TOP study. We believe that the reduction in fracture risk seen in this study suggests that PREOS promises to be an effective alternative for physicians when choosing appropriate therapies for their patients who have mild osteoporosis, as well as in patients with more serious disease. We will continue to analyse the large amount of data collected in the TOP study as we prepare our NDA submission so that we will have a thorough understanding of how PREOS may best be used.'