Roche stopped dosing patients in late-stage trials of its experimental diabetes drug taspoglutide after a higher than expected rate of discontinuations due to gastrointestinal adverse events were seen in subjects administered the once-weekly treatment. "These discontinuation rates compromise interpretation of the long term safety data from the T-emerge studies, therefore continuing treatment with the current taspoglutide formulation is not considered to be in the best interest of patients," the Swiss drugmaker noted.
The company said the decision to halt dosing in the T-emerge programme was based on 52-week data from the trials, which showed that along with gastrointestinal adverse events, some patients receiving taspoglutide suffered serious hypersensitivity reactions. Spokesman Terrence Hurley remarked that "Roche is assessing approaches to identify the root cause of the serious hypersensitivity reactions and to optimise the taspoglutide formulation to improve GI tolerability," adding that "upon review of options available, Roche will communicate about the next steps of the overall taspoglutide programme by year end."
However, Leerink Swann analyst, Joshua Schimmer, noted that if Phase III dosing has been suspended, "we believe that this is the final blow for what was perceived as a compound in trouble after the disappointing data on hypersensitivity and nausea/vomiting presented at the American Diabetes Association [meeting] this year."
In June, Roche, which licensed rights to taspoglutide from Ipsen, indicated that regulatory filings for the drug would be delayed by 12 to 18 months after reports of a higher incidence of hypersensitivity reactions in patients receiving the therapy. The company previously estimated that sales of taspoglutide could reach at least 2 billion Swiss francs ($1.9 billion), although analysts lowered this figure given reports of the delay in filing.
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