The pursuit of oral insulin

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It’s been 12 months since Novo Nordisk made the difficult decision to discontinue its oral insulin development programme. Here, Chief Science Officer Mads Krogsgaard Thomsen reflects on a year of learning, on what motivates him and his team and on the possibility to one day revisit the potential of oral insulin.

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By Mads Krogsgaard Thomsen, Chief Science Officer of Novo Nordisk  |  Published 10 November 2017

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The story of oral insulin is closely linked with the discovery of the hormone itself a century ago as well as Novo Nordisk’s own history. In fact, when the co-discoverer of the molecule Frederick Banting first gave insulin to a person with diabetes in 1921, it was administered orally – though sadly without success. And, ever since I joined Novo Nordisk more than 25 years ago, oral insulin has been the ‘Holy Grail’; a breakthrough that we know could help many people living with diabetes.

That is why the past year has been one of mixed emotions for me as chief science officer. From a scientific point of view, I am extremely proud of how far we have come in developing oral insulin, and I am grateful to the colleagues who worked so hard to achieve this. Our scientists were the first to show that it is possible to deliver basal insulin in a once-daily tablet form. We’ve created the molecule that can survive the tough environment of the gastro-intestinal tract before being absorbed and lowering blood glucose levels as a modern, injectable basal insulin would. In scientific terms, this is a tremendous step forward of which I am extremely proud.

But scientific achievements do not always result in medicines in the hands of patients and, in this case, science alone was not enough. This is deeply frustrating for both people with diabetes and for Novo Nordisk. Because when patients hear about our latest research results in oral insulin, their first question, understandably, is “when can this tablet be on the market?”

The missing piece of the puzzle

The fact is that the technology to ensure that the insulin molecule is taken up in the body in sufficient quantities simply does not exist. It’s this delivery mechanism - the bit that wraps around the molecule in order to get it into the bloodstream - that must be improved in order for oral insulin to be viable. As things stand, oral treatment is not optimal for the patient from a medical perspective, and would neither be sustainable from a commercial nor a manufacturing perspective for Novo Nordisk.

With the modest absorption rate we have been able to achieve with currently available technology, we would need to build and staff at least one replica of our well-established Kalundborg insulin production plant – the world’s largest of its kind – to even begin to deliver enough of the raw insulin product. Such an undertaking is one that neither Novo Nordisk, nor the health systems we serve, could economically sustain in order to improve the convenience but not the effectiveness of insulin therapy.

So, where are we now? We do still believe in the potential of oral insulin and the convenience it holds for people with diabetes. With the missing piece of the puzzle being a breakthrough within drug delivery systems, we will work closely with external scientific collaborators over the coming years, to see if there is a viable delivery technology that we can combine with our molecule and bring into the clinic to test in humans.

We are very conscious that oral insulin remains a ‘Holy Grail’ for many people living with diabetes, and it is the needs of patients that guides our company in everything we do – from the design of our insulin pens to the choices we make when prioritising research efforts. Our entire organisation is focused on placing patients’ needs first.

Tackling the toughest problems in diabetes

I witness examples of this extraordinary focus and motivation in our scientists every day. Many of them come to work at Novo Nordisk because they have diabetes themselves or because they know someone with the condition within their family or friends. Together, we have a shared commitment to tackle the toughest problems in diabetes. But science can’t be rushed – as the near-one hundred year search for oral insulin illustrates so clearly.

Glucagon-like peptides (GLP-1) is an example of one class of diabetes medicine where we have had to show patience and perseverance across three decades before we could unlock the scientific potential. I heard about these molecules on my very first day in a Novo Nordisk lab. In the years that have followed, we’ve taken them from being something that worked when infused in mice by pump, to something that can be given to humans in clinical trials via a once-a-day tablet. This is another achievement I am very proud of, and one that shows that we have a track record of not giving up.

What motivates and drives the Novo Nordisk R&D organisation every single day is the knowledge that there’s still much more our research can do to make it easier to manage diabetes – even one day maybe to cure it.

We know that we work for a company that is virtually synonymous with diabetes. I am confident that if oral insulin can one day be delivered, Novo Nordisk will achieve it. In the meantime, we will continue to work, as hard as ever, in our labs, with a dedicated focus to deliver innovation that improves the lives of the millions of people with diabetes.

For more information, contact Adam Pittard, Corporate Editor.

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