Taspoglutide: Additional Phase III data

Roche discontinued dosing of patients in the 8 Phase III trials of its T-emerge program of taspoglutide to treat Type II diabetes after 52-week data from some of the trials showed higher than expected discontinuation rates due to gastrointestinal adverse events, including nausea and vomiting. In June, Roche said regulatory submissions for taspoglutide would be delayed after the pharma implemented a risk mitigation plan to address similar hypersensitivity issues (see BioCentury, June 21).

Roche spokesperson Kristina Becker said the company would continue to follow patients enrolled in the T-emerge trials. The company is "assessing approaches" to identify the cause of the GI reactions and to optimize the compound's formulation, according to Becker. She added that the pharma will communicate next steps of the overall taspoglutide program by year end. ...