Victoza pill trial begins
pharmafile | January 19, 2010 | News story | Research and Development, Sales and Marketing | GLP-1, Novo Nordisk, Victoza, diabetes, type II
A promising new diabetes treatment which can be taken as a pill instead of as an injection has just begun phase I trials.
Novo Nordisk is working with drug delivery specialists Emisphere on the oral version of a GLP-1 (Glucagon-Like Peptide-1) which could eventually be a breakthrough in diabetes treatment.
Victoza (liraglutide) is the first GLP-1 analogue with a 24-hour duration of action developed to treat type II diabetes and was launched in July 2009 in Europe.
Launched in Germany, Britain and Denmark last year, Novo say the drug is already selling well, even ahead of further launches across Europe.
But the treatment is still held back by the need to inject it, and Novo Nordisk and Emisphere hope they have solved the problem of turning the drug into a pill.
The trial (being conducted in the UK) aims to investigate the safety, tolerability and bioavailability of NN9924 in healthy volunteers. A total of 155 people are to be enrolled on the trial, and it is are expected to report its findings in 2011.
Developing an oral formulation of GLP-1 has many obstacles, in particular obtaining adequate bioavailability (absorption of the drug in the body). NN9924 addresses some of the key challenges, and utilises the Eligen formulation technology from Emisphere to facilitate GLP-1 absorption from the gut.
“We still have a long road with many challenges ahead of us before a GLP-1 pill becomes a reality,” says Peter Kurtzhals, senior vice president and head of diabetes research at Novo Nordisk. “But with the progress we have made so far I am convinced it is only a matter of time before we make it.”
Michael Novinski, president and chief executive, Emisphere Technologies, says: “This milestone reflects a major achievement for our programme and partnership with Novo Nordisk and is one small but significant step forward in the development of a successful treatment for type II diabetes. As a company, we are extremely encouraged by the progress to date and look forward to the future and the potential benefits this programme may bring to the millions of patients being treated for this disease.”
Novo Nordisk and Emisphere began their collaboration in June 2008 to develop and market oral formulations of Novo Nordisk’s proprietary GLP-1 analogues, using Emisphere Eligen Technology. This is the first development milestone achieved by Emisphere under this agreement.
The drug is particularly promising as it helps to control the weight of patients taking it.
Victoza has produced impressive weight loss in phase II clinical trials, but final phase III obesity studies have been put on hold pending a final decision by the FDA on diabetes.
Victoza and Byetta both belong to the GLP-1 class of drugs that stimulate insulin release when glucose levels become too high. Rival GLP-1 treatments are also being developed by companies including GlaxoSmithKline and Roche.
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