Ipsen’s Partner Roche Announces Amendment of the Trial Protocols for the Taspoglutide Phase III Programme
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Ipsen has announced that its partner Roche announced the implementation of a risk mitigation plan in the taspoglutide Phase III programme. Taspoglutide, the first once weekly glucagon-like peptide-1 (GLP-1) analogue based on a human sequence, originating from Ipsen’s research is developed by Roche. This compound is similar to the natural hormone GLP-1 which has a key role in blood sugar regulation.
In the Phase III studies, the incidence of hypersensitivity reactions reported as related to taspoglutide is higher than expected for the study population, although it remains uncommon (i.e. incidence < 1%). The most frequently reported symptoms in patients who developed hypersensitivity reactions were skin reactions and gastrointestinal symptoms, while cardiovascular and respiratory symptoms were less frequent. All patients recovered without complications.
Roche has identified a potential association between hypersensitivity reactions and anti-drug antibodies (ADAs). In consultation with the Food and Drug Administration (FDA), Roche has decided to implement a risk mitigation plan, which has been communicated to Health Authorities globally. The plan is designed to identify patients at potential risk of these reactions. As such, ADA levels will be routinely monitored and patients that develop pre-specified ADA levels will discontinue treatment and continue to be monitored in the trials. The continued safety of patients in the clinical development programmes remains the highest priority for Roche. Roche is committed to working with Health Authorities globally to continue the development of taspoglutide to meet the needs of patients with type 2 diabetes. Roche is investigating the cause of the hypersensitivity reactions and testing specific means to resolve this issue.
The impact of this plan on the project and in particular on the timelines for regulatory filing are currently being assessed, however, a minimum of 12 to 18 months delay is anticipated.
Roche looks forward to sharing with the medical community at the forthcoming American Diabetes Association, data from five phase III trials demonstrating that taspoglutide delivered combined benefits of consistent robust glycemic control, across a wide spectrum of patients versus exenatide, sitagliptin and even the highest dose of insulin glargine used in a development program. In addition, taspoglutide was associated with a low risk of hypoglycaemia and clinically important weight loss. Over the next few weeks, Roche also expects to get the headline data on the 52-week extended trials.
In the Phase III studies, the incidence of hypersensitivity reactions reported as related to taspoglutide is higher than expected for the study population, although it remains uncommon (i.e. incidence < 1%). The most frequently reported symptoms in patients who developed hypersensitivity reactions were skin reactions and gastrointestinal symptoms, while cardiovascular and respiratory symptoms were less frequent. All patients recovered without complications.
Roche has identified a potential association between hypersensitivity reactions and anti-drug antibodies (ADAs). In consultation with the Food and Drug Administration (FDA), Roche has decided to implement a risk mitigation plan, which has been communicated to Health Authorities globally. The plan is designed to identify patients at potential risk of these reactions. As such, ADA levels will be routinely monitored and patients that develop pre-specified ADA levels will discontinue treatment and continue to be monitored in the trials. The continued safety of patients in the clinical development programmes remains the highest priority for Roche. Roche is committed to working with Health Authorities globally to continue the development of taspoglutide to meet the needs of patients with type 2 diabetes. Roche is investigating the cause of the hypersensitivity reactions and testing specific means to resolve this issue.
The impact of this plan on the project and in particular on the timelines for regulatory filing are currently being assessed, however, a minimum of 12 to 18 months delay is anticipated.
Roche looks forward to sharing with the medical community at the forthcoming American Diabetes Association, data from five phase III trials demonstrating that taspoglutide delivered combined benefits of consistent robust glycemic control, across a wide spectrum of patients versus exenatide, sitagliptin and even the highest dose of insulin glargine used in a development program. In addition, taspoglutide was associated with a low risk of hypoglycaemia and clinically important weight loss. Over the next few weeks, Roche also expects to get the headline data on the 52-week extended trials.
