Oral Insulin Phase 1 Trials Begin

Novo Nordisk has initiated its first Phase 1 clinical trial with an oral insulin analog, NN1952, which was created using Merrion Pharmaceuticals’ GIPET technology.

There are many challenges with the development and production of a reliable insulin formulation for oral use. These 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 at a sufficient scale cost-effectively.

NN1952 has been designed to address some of the key challenges relating to oral insulin delivery. The GIPET formulation technology from Merrion Pharmaceuticals helps facilitate insulin absorption from the gut.

NN1952 is not the only oral insulin formulation being tested. The Chinese State Food and Drug Administration (SFDA) has recently approved the investigational new drug application (IND) for Shanghai Biolaxy’s (Shanghai, China) oral insulin project (Nodlin). This IND approval allows Biolaxy to initiate its first Phase 1 clinical study.

Nodlin is developed with a patented bio-adhesive nanoparticle oral delivery (NOD) technology to overcome the barriers of oral insulin. Nodlin is the first candidate developed with NOD technology and is positioned as basal insulin formulation based on the preclinical data.