Novo Nordisk has initiated its first Phase I trial with an oral insulin analogue, called NN1952, which it hopes could one day provide an alternative to daily injections for diabeties patients.

The aim of the trial, which is conducted in Germany, is to investigate the safety, tolerance, pharmacokinetics and pharmacodynamics of NN1952 in healthy volunteers and people with type 1 and type 2 diabetes. Results from the trial, which is planned to enrol about 80 people, are expected to be reported in the first half of 2011.

Novo says that there are “many challenges with the development and production of a reliable insulin formulation for oral use”. They include avoiding enzymatic degradation in the gastrointestinal tract, overcoming poor spontaneous insulin permeability over the intestinal wall, limiting variability of absorption (caused, for example, by interaction with food) “and producing insulin in sufficient scale cost-effectively”.

Peter Kurtzhals, head of diabetes research at Novo, said “we still have many challenges to overcome, and it is far too early to say whether or when oral insulin will become an alternative to insulin injections”. However he is encouraged by the progress “our R&D teams have made during the past two years, and which has led us to this important milestone”.

Cash boost for partner Merrion
News of the trial releases a $2 million to Ireland’s Merrion Pharmaceuticals, whose Gipet technology is used in the formulation of NN1952 which facilitates insulin absorption from the gut.

John Lynch, chief executive of Merrion, said the payment, “which we have achieved by meeting all necessary deadlines”, is an extremely positive development” and this is a major programme for
his firm. He added that “we are determined to ensure that our highly motivated team of specialists maximises the likelihood of success for Novo’s oral insulin candidates”.