Novo Nordisk has initiated its first phase-1 clinical trial with a long-acting oral GLP-1 analogue (NN9924). This milestone releases a two million dollar payment to Emisphere Technologies, Inc, whose proprietary Eligen Technology is used in the formulation of NN9924.

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 enrol 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 (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 V Novinski, president and chief executive officer, 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 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.”

In June 2008, Novo Nordisk and Emisphere entered into a development and licence agreement to develop and commercialise 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.

Novo Nordisk is a healthcare company and a world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy.