ARTICLE | Clinical News

Oral calcitonin misses OA endpoint

October 23, 2010 12:31 AM UTC

Emisphere Technologies Inc. (OTCBB:EMIS) said partner Novartis AG (NYSE:NVS; SIX:NOVN) reported that oral salmon calcitonin ( SMC021) missed the co-primary endpoint of significantly improving joint space width in the medial tibio-femoral knee joint vs. placebo in the Phase III Study 2301 trial to treat osteoarthritis (OA). Novartis did say data for the solid oral formulation of synthetic salmon calcitonin hormone "indicated clinical efficacy" on the two other co-primary endpoints -- pain and functional disability as measured by WOMAC scores. According to Emisphere, Novartis and development partner Nordic Bioscience Holding (Herlev, Denmark) plan to further analyze the results. The double-blind, international trial enrolled up to 1,150 patients.

In July, Emisphere said a futility analysis of one-year data from the Phase III Study 2302 trial of SMC021 to treat OA of the knee prompted an independent DMC to recommend stopping the trial for efficacy reasons. Novartis and Nordic said they will continue the two-year trial, but declined to provide a reason why. ...