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Insulin is one of the most important drugs in the history of pharmaceuticals. Since the separation of active insulin from animals by the Canadian doctor Frederick Grant Banting, it has been around for nearly a hundred years and has been continuously upgraded to meet the demand for diabetes.

To date, insulin therapy is still the most effective way to treat diabetes, and the conversion of insulin injection into oral preparations has been regarded as one of the hot clinical needs, and the market size is expected to exceed 10 billion US dollars.


Inspiration from the tortoise

Recently, according to Science, researchers at the Massachusetts Institute of Technology, Brigham and Women’s Hospital and Novo Nordisk have proposed a product called “oral insulin pills.” This is a blueberry-sized oral capsule that carries a small probe made of insulin and is connected to a spring device that is pressed by a sugar piece.

When the capsule enters the stomach, it can adjust its orientation to ensure that it is in contact with the tissue of the stomach wall. After the stomach acid dissolves the tablet, the spring injects a small probe composed of insulin into the stomach wall to achieve the effect of delivering insulin.

Scientists say the design was inspired by leopard tortoise. Animal experiments in rats and pigs have shown that the level of blood glucose lowering is similar to that of insulin injection.


Oral insulin research is long

For some people with diabetes, daily injections are a heavy burden, and the needles used to inject insulin are as important as the faucets of drinking water. To this end, the pharmaceutical industry has tried the development of non-injected insulin since the first day of insulin discovery, but progress has been very limited in the last hundred years.

In fact, as the overlord in the field of diabetes, this is not the first time Novo Nordisk has laid out oral insulin. Novo Nordisk announced in 2012 that it will invest nearly $4 billion to develop oral insulin and is expected to be available within 8 to 10 years.

In the first half of 2016, Novo Nordisk completed Phase IIa clinical trial of the oral insulin project OI338GT, and published detailed Phase IIa clinical trial data at 2017ADA (American Diabetes Association Scientific Annual Meeting) and EASD (European Diabetes Research Society Annual Meeting). The OI388GT is as effective as Sanofi in injecting Lantus in controlling blood sugar levels.

Regrettably, Novo Nordisk announced the termination of the OI338GT study as early as October 2016. The official reason is that “the consideration for the high level of commercial operation in the early stage”. However, the industry believes that the reason for its termination is that OI338GT capsules have higher requirements for insulin raw material production capacity, and the production capacity pressure is not small. The project was terminated due to cost considerations.

Dr. Mads Krogsgaard Thomsen, Chief Scientific Officer of Novo Nordisk, said in a blog post that the company still believes in the potential of oral insulin. The cooperation with institutions such as the Massachusetts Institute of Technology shows that it is undead in this field.

Novo Nordisk is not the only distributor in the field of “oral insulin”. In 2017, Sanofi and Enteris BioPharma reached a research agreement to use the latter’s oral delivery platform for the treatment of type 2 diabetes.

Oramed’s oral insulin capsule ORMD-0801 has been in Phase II clinical trials. On November 13, 2018, Oramed announced that it has successfully randomized more than 50% of the expected 285 patients to the 90-day dose range of the ORMD-0801 Pivotal Phase 2b clinical study to generate meaningful data for efficacy and safety endpoints. .


Can it reinvigorate Novo Nordisk’s long-term high growth?

Inhaled insulin was a hot trend more than a decade ago. Inhaled insulin products are not optimistic about the market due to problems such as lung safety and drug absorption stability.

One of the most promising ones was Pfizer’s first-listed Exubera, which was predicted to peak sales of $3 billion, but sold only 12 million in the first year and then delisted.

In the industry’s opinion, the partial failure of Exubera is related to the device being too clumsy. Unfortunately, Mannkind subsequently launched a more sophisticated inhaled insulin, Afrezza, but the market absorption is still very slow.

Due to increased competition in the diabetes market and price pressures, Novo Nordisk had to get rid of the dependence on traditional injections of insulin products as soon as possible. Just a few days ago, Novo Nordisk announced that the 2018 financial report showed that the market share of insulin in the global insulin accounted for nearly half of the increase in insulin in the past half of the year.

To this end, Novo Nordisk-MIT scientists are working to optimize the manufacturing process of this product, while further research to determine the long-term effects of daily gastric injection. Novo Nordisk plans to conduct human clinical trials of the product within three years.

Professor Robert Langer, co-senior author of the study, said in a statement: “We firmly believe that this new capsule will one day help diabetics who are currently only treated by injection or infusion.”

Scientists say the drug delivery platform not only delivers insulin, but also delivers a wider range of biological agents traditionally required to be injected, including peptides and nucleic acids such as DNA therapy and RNA therapy.

Can this oral insulin capsule inspired by the turtle help Novo Nordisk return to the long-term high growth era? Since it has not yet entered clinical trials and there is not enough human data to verify its effectiveness, we can only wait and see.

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