ARTICLE | Clinical News

Oral salmon calcitonin: Development discontinued

December 19, 2011 8:00 AM UTC

Emisphere said partner Novartis discontinued development of SMC021 to treat postmenopausal osteoporosis and OA. Emisphere said the pharma's decision was based on data from the Phase III Study 2303 trial in postmenopausal osteoporosis and the Phase III Study 2301 and 2302 trials in OA. Novartis' development partner Nordic Bioscience conducted the trials.

Last month, Novartis reported preliminary data from Study 2303 in women with postmenopausal osteoporosis that showed SMC021 missed the primary endpoint of significantly reducing the occurrence of new vertebral fractures vs. placebo at 3 years (see BioCentury, Nov. 21). Additionally, previously reported data from Study 2301 and 2302 in OA patients showed that SMC021 missed the co-primary endpoint of significantly improving joint space width in the medial tibio-femoral knee joint vs. placebo in both trials (see BioCentury, Oct. 25, 2010 & Oct. 17, 2011). ...