Future of Roche diabetes trial uncertain
pharmafile | September 14, 2010 | News story | Research and Development | GLP-1, Roche, taspoglutide
Roche has admitted it does not know when phase III trials of the investigational type II diabetes drug taspoglutide will resume following their suspension.
The manufacturer says the phase III trials programme – called T-emerge – is ongoing although it has halted dosing patients.
Researchers were ordered to stop giving patients the drug because so many were dropping out due to adverse side effects.
These discontinuation rates “compromise interpretation of the long term safety data from the T-emerge studies”, the company acknowledges. It is a blow for Roche, which in February said taspoglutide, the first weekly human glucagon-like peptide-1 (GLP-1) analogue to get to late stage trials, had been generally well tolerated in phase III.
But it now says that “higher than expected discontinuation rates, mainly due to gastrointestinal (GI) tolerability, have been observed”.
The news will be a present for Novo Nordisk, whose once-daily injectable GLP-1 Victoza (liraglutide) is set to be approved by NICE at a 1.2mg dose.
Taspoglutide was lined up to offer stiff competition since patients would only have to take it weekly.
Roche says the incidence of GI effects was higher with taspoglutide than with other GLP-1s and the decision to cease dosing was taken in order “to assess approaches to identify the root cause of the serious hypersensitivity reactions and to optimise the taspoglutide formulation to improve GI tolerability”.
Roche stops short of saying it will abandon taspoglutide altogether, and insists it will provide more information by the end of 2010 on how the programme will proceed.
“Continuing treatment with the current taspoglutide formulation is not considered to be in the best interest of patients,” the company adds.
About 4,000 patients are affected by the decision, but Roche said incidence of serious hypersensitivity reactions “represents less than 1% of the patient population”.
A “risk mitigation plan” has been implemented to address the serious hypersensitivity reactions, it says.
Early results from the weekly dose were positive, with taspoglutide reducing blood sugar in the first five phase III studies.
The drug is similar to the naturally occurring human hormone GLP-1 which plays a key role in blood glucose metabolism.
Adam Hill
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