Roche and Ipsen's investigational diabetes drug taspoglutide has been shown to be generally well-tolerated and efficacious for the treatment of patients with type 2 diabetes, resulting in significant improvements in glucose control and weight loss after only eight weeks of treatment.
Taspoglutide, the first human once weekly glucagon-like peptide-1 (GLP-1) analogue originating from Ipsen's research, is a compound similar to the natural hormone GLP-1 which has a key role in blood sugar regulation. Based on these promising phase II results, presented at the American Diabetes Association (ADA) in San Francisco, US, Roche has made the decision to move taspoglutide into phase III clinical trials with the programme anticipated to start in the second half of 2008.
"These data reinforce the role of GLP-1 in type 2 diabetes and Roche and Ipsen believe taspoglutide has the potential to be a best-in-class treatment," said William M Burns, CEO Pharmaceuticals Division of Roche and Jean-Luc Bélingard, chairman and CEO of the Ipsen Group. "GLP-1 analogues, which stimulate insulin secretion and suppress glucagon secretion, are true innovations in the diabetes field. Roche and Ipsen are pleased to move this potentially best-in-class product into phase III trials and look forward to working together to bring it to market," they said.
The phase II studies showed that the safety profile of taspoglutide, which originates from Ipsen's research, supports the move into phase III, with the most common adverse event reported being mild-to-moderate nausea. These events were dose-dependent and in most cases, resolved spontaneously while continuing on therapy.
"These data show that taspoglutide is a promising and highly efficacious once weekly treatment for obese patients with type 2 diabetes mellitus no longer controlled on oral antidiabetic medications," said lead author, Professor Michael Nauck, head of the Diabeteszentrum Bad Lauterberg, Germany. "Like improved glucose control, drug-induced weight loss is particularly beneficial for this type of patients. We will wait to see the phase III results with interest".
Roche exercised its licensing option for taspoglutide from Ipsen in 2006 and acquired exclusive worldwide rights to develop and market taspoglutide, except in Japan where these rights are shared with Teijin and in France where Ipsen may elect to retain co-marketing rights.
Taspoglutide was selected from a family of human once-weekly long-acting glucagon-like peptide-1 (GLP-1) analogues with structural modifications which confer intrinsic controlled release properties. Ipsen is the originator of the concept of matrix free sustained release formulation applied to therapeutic peptides and proteins.