Novo Nordisk says its long-acting oral insulin could become a lead product following the successful completion of an early-stage trial.
Novo Nordisk, in partnership with Ireland based Merrion Pharmaceuticals, has been working on creating a way of delivering insulin orally which could change the lives of millions of diabetes sufferers, currently reliant on injectables. Now the Danish drugmaker has announced its NN1954 candidate has taken a small step to becoming a marketable therapy after success in a single dose Phase I trial.
Speaking with in-Pharmatechnologist.com, Novo Nordisk Head of Diabetes Research Unit Peter Kurtzhals said the candidate could be a “potential gross driver for the future” feeding “Novo Nordisk’s ambition of being the world’s leading diabetes company.”
The therapy would help control diabetes, allowing type-2 patients to begin insulin therapy earlier and would replace injections - which have a number of issues regarding practicality and safety - in administrating the drug.
However, though this move towards oral delivery has benefits for patients, Kurtzhals said he doesn’t “expect oral insulin would completely substitute injections” and would only be viable, to begin with, for sufferers of type-2 diabetes.
It would be “much too hopeful for type-1 needs,” he said, though if the drug is successful and reaches the market – realistically, according to Kurtzhals, in the next ten years – the opportunity to adapt the drug “would be a challenge but potentially one to be explored.”
Long Acting Insulin
Novo Nordisk is not the only developer in the oral insulin field. Recently Indian biotech firm Biocon has been searching for partners following failure in a late-stage trial in patients with type-2 diabetes of its oral insulin candidate, IN-105, and last year Tamarisk Technologies showed off its insulin-shrinking platform claiming it could “turn the industry upside-down.”
However, Kurtzhals told us that while “all other companies - including Biocon and Tamarisk – have been focusing on short-acting insulin,” the major opportunity lies in the fact that NN1954 is a long-acting, slow-release drug.
NN1954 benefits from the GIPET platform which, according to the technology’s developer Merrion, has boosted absorption by up to 50 times that of traditional tablets in clinical trials.
The GIPET platform was created in order to convert injection-only drugs into tablet or capsule form without losing efficacy or pushing bioavailability to impractical levels.
According to Merrion, patented absorption enhancers facilitate the transportation of the drug and substantially increasing absorption. The specially coated tablet targets the duodenum and dissolves, releasing both the drug and the absorption enhancer which pass through the duodenal cell membrane.
Novo Nordisk has full access to the platform having entered into an agreement with Merrion in 2008. Under the terms Merrion will receive payments on achievement of certain development, regulatory and sales milestones as well as royalties on sales.