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news.Novo Nordisk has initiated its first phase 1 clinical trial with a long-acting oral GLP-1 analogue (NN9924). This milestone releases a $2m payment to Emisphere Technologies, whose proprietary Eligen technology is used in the formulation of NN9924.
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GLP-1 (Glucagon-Like Peptide-1) is a natural hormone involved in controlling blood sugar levels. It stimulates the release of insulin only when blood sugar levels become too high. In people with type 2 diabetes, GLP-1 secretion is often impaired.
The aim of the trial, which is conducted in the UK, is to investigate the safety, tolerability and bioavailability of NN9924 in healthy volunteers. Results from the trial, which is planned to enroll about 155 people, are expected to be reported in 2011.
There are many challenges in developing a formulation of GLP-1 for oral use, in particular obtaining adequate bioavailability. NN9924 addresses some of the key challenges, and utilises the Eligen formulation technology from Emisphere to facilitate GLP-1 absorption from the gut.
Peter Kurtzhals, senior vice president and head of diabetes research at Novo Nordisk, said: “We still have a long road with many challenges ahead of us before a GLP-1 pill becomes a reality. 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 officer of Emisphere, said: “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 2 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.”
Earlier in June 2008, Novo Nordisk and Emisphere entered into a development and license agreement to develop and commercialise oral formulations of Novo Nordisk’s proprietary GLP-1 analogues, using Emisphere Eligen Technology.