The phase II, double blind, placebo-controlled study will evaluate the efficacy and safety of compound 751689 over a 12-month period. The study will enroll approximately 520 post-menopausal women with osteoporosis and is designed to assess the overall efficacy, safety, and tolerability of 751689 in comparison with placebo and two active comparators.
Outcome measures include bone mineral density of the lumbar spine and hip, vertebral and hip strength parameters, and biomarkers of bone turnover. Data from this study, along with other data, will be used to select a dose of compound 751689 for further evaluation.
“We are pleased that the development of the calcilytics program is advancing under GSK’s leadership. We believe that calcilytics have the potential to represent an important new class of drugs for the treatment of osteoporosis and look forward to the results of this exciting trial,” commented NPS CEO and president, Dr Tony Coles.
Under the terms of a collaborative research and license agreement with GSK, NPS will receive royalties on global product sales and has the option to co-promote products resulting from the collaboration with GSK in the US.