Denmark-based Novo Nordisk has begun a Phase 1 trial of a pill form of a GLP-1 drug very similar to its Victoza product. The trial will involve 155 British patients with type 2 diabetes. The test on human subjects, although very early-stage, puts the company in the lead to develop an oral form of a GLP-1 drug.
GLP-1-glucagon-like peptide-is a delicate gut hormone whose beneficial effects on the digestive system have made it one of the most promising diabetes therapies in modern times. Those effects include:
- Stimulation of insulin production
- Decrease of pancreatic glucagon production
- Increase in pancreas beta cell mass
- Inhibition of acid secretion and gastric emptying in the stomach
- Increase in insulin sensitivity
- Increase in feelings of satiety, leading to less food intake
Novo’s version of GLP-1, Victoza, like all other GLP-1s on the market, must be taken by injection. The relative fragility of the protein-based drug, which gives it a “half life” of two minutes once it circulates in the body, requires the direct application that only injections can give.
(GLP-1 analogs like exenatide and liraglutide must also be taken by injection.)
If Novo can create an effective version of Victoza in pill form, the marketing advantages would be formidable. Most type 2 patients who are taking GLP-1 drugs, if given a choice between daily injections and pills, would opt for pills. But Novo still has to overcome the biggest challenge in developing an oral diabetes medication: how to get the fragile molecules in the drug through the acid baths of the digestive system to the point where they can enter the bloodstream.
Novo is banking on Eligen®, a drug delivery technology developed by one of its research partners, Emisphere Technologies in New Jersey. Eligen® facilitates the very rapid absorption of molecules across cell membranes in the gut and into the bloodstream-crucial to preserving their viability.
The test with British subjects is expected to yield first results by 2011.
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