LOS ANGELES – Roche Holding AG and Ipsen SA said Monday they plan to launch a pivotal trial of experimental diabetes drug taspoglutide after it was shown to improve blood sugar control in a mid-stage trial.
The companies said treatment with the once-weekly medication, part of a new class of drugs similar to blood sugar-regulating hormone GLP-1, also resulted in weight loss for patients in an eight-week Phase II trial.
“It has the potential to have very strong effects on blood glucose and weight loss in an easy, simple device,” said Luke Miels, head of strategic marketing for metabolic diseases at Roche.
Studies so far have shown the drug is safe, with the most common side effect being mild-to-moderate nausea, Roche said.
The Phase III trial is expected to start in the second half of this year and the partners expect to file for regulatory approval of the drug in 2010, Miels said.
Currently, the only GLP-1 diabetes drug on the market is Amylin Pharmaceuticals Inc's Byetta, given by injection twice a day. Amylin is also developing a longer-lasting version of its drug that would be given once a week.
Miels said potential advantages of taspoglutide include that it is “human-sourced,” whereas Byetta is a synthetic version of a hormone in the saliva of the Gila Monster lizard.
He also said an easier, once-weekly dosing schedule and smaller-gauge needle would be competitive advantages for Roche.
Novo Nordisk A/S filed last month for regulatory approval of its GLP-1 analogue liraglutide, which is given in a daily injection.
Miels said Roche plans to compare its drug in head-to-head trials against exenatide and liraglutide.
Roche, based in Switzerland, exercised its licensing option for taspoglutide from Ipsen in 2006 and acquired exclusive worldwide rights to develop and market the drug, except in Japan where rights are shared with Teijin and in France where Ipsen may elect to retain co-marketing rights.
(Reporting by Deena Beasley; Editing by Braden Reddall, Toni Reinhold)