GSK’s diabetes candidate enters phase III
pharmafile | February 19, 2009 | News story | Research and Development | GSK, diabetes
A large scale study of GlaxoSmithKline's type II diabetes candidate Syncria (albiglutide) has begun.
Albiglutide is an investigational biological drug, and is an injectable form of human GLP-1. This is a peptide that helps maintain normal blood-sugar levels and control appetite, and is found in reduced levels in patients with type II diabetes.
GSK's drug is just one of a number companies with GLP-1 drugs in development, a class of drugs which may play a major role in developing treatment of type II diabetes.
GSK says if proven to be safe and effective, Syncria would only have to be injected once a week or even less frequently. The drug would typically help type II diabetes patients who are unable to control their blood glucose with oral treatments alone.
A similar drug, Lilly's Byetta (exenatide), is already on the market, having been launched in 2005. The twice daily injection has reached sales of $751 million in 2008, but has recently hit problems with serious safety concerns.
Byetta's US sales fell in the final quarter of 2008 after it was linked to fatal pancreatitis seen in a handful of patients taking the medication. The FDA is expected to demand new label warnings for the drug in the US, which would suppress the drugs sales further.
The safety scare around Byetta could cast doubt on GSK's new drug, and at the very least will increase the demand for safety data.
Meanwhile, another drug in the GLP-1 class Novo Nordisk's Victoza (liraglutide) is to be reviewed by the US regulator in April.
Syncria is different from Byetta and Victoza in that it fuses human GLP-1 to human albumin, as opposed to the other drugs which are analogues. This difference could mean a better safety profile for Syncria, but this will be difficult to demonstrate in phase III trials.
The phase III programme for albiglutide will begin with five studies to demonstrate durable efficacy and cardiovascular safety of the drug as mono- and add-on therapy.
The primary efficacy endpoint for all studies will be the change from baseline in HbA1c compared to placebo and/or active comparators. Most of the studies will include active comparators, including metformin, sulphonylurea, thiazolidinedione (TZD) insulin and a dipeptidyl peptidase four inhibitor (DPP IV).
Other companies have their own GLP-1 candidates in the pipeline. Sanofi-Aventis, also has its own GLP-1 agonist in development, a once-a-day injection currently in phase II trials.
Roche and Ipsen also have their own candidate, taspoglutide, which entered phase III trials in 2008.
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