Emisphere Technologies: Novo Nordisk initiates first Phase I clinical trial of GLP-1

Emisphere Technologies, Inc. today announced that Novo Nordisk has initiated its first Phase I clinical trial with a long-acting oral GLP-1 analogue (NN9924). This milestone releases a $2 million payment to Emisphere, whose proprietary Eligen^® Technology is used in the formulation of NN9924.

“But with the progress we have made so far I am convinced it is only a matter of time.”

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. GLP-1 secretion is often impaired in people with Type 2 Diabetes.

The aim of this trial, which is being conducted in the UK, is to investigate the safety, tolerability and bioavailability of NN9924 in healthy volunteers. The trial will enroll approximately 155 individuals and results from the trial are expected in 2011.

There are many challenges in developing an oral formulation of GLP-1, in particular obtaining adequate bioavailability. NN9924 addresses some of these key challenges by utilizing Emisphere’s Eligen^® Technology to facilitate absorption from the gut.

“We still have a long road with many challenges ahead of us before an insulin pill or 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.”

Michael V. Novinski, President and Chief Executive Officer, Emisphere Technologies, says, “This milestone reflects a major achievement for our program 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 program may bring to the millions of patients being treated for this disease.”

In June 2008, Novo Nordisk and Emisphere entered into a development and license agreement to develop and commercialize oral formulations of Novo Nordisk’s proprietary GLP-1 analogues, using Emisphere’s Eligen^® Technology. This is the first development milestone achieved by Emisphere under this agreement.