Insulin is one of the most important drugs in pharmaceutical history.Since Frederick Grant Banting isolated active insulin from animals, nearly a hundred years ago, it has been escalated to meet the needs of diabetes treatment.
1.Inspiration from the Turtle.Researchers at Brigham and Women's Hospital and Novo Nordisk have come up with a product called an oral insulin pill.It is a blueberry size capsule for oral administration, carrying a small probe made of insulin, connected to a spring device held down by sugar tablets.
Scientists say the design was inspired by leopard tortoise.Current animal studies in rats and pigs have shown that the blood sugar level is similar to that of injected insulin.
2.Oral insulin has a long way to go.For this reason, the pharmaceutical industry has tried the development of non-injectable insulin since the first day of insulin discovery, but the progress in the last 100 years has been very limited.
In fact, this is not the first time that Novo Nordisk has laid out oral insulin as a leader in the diabetes field.Novo Nordisk announced in 2012 that it will invest nearly $4 billion in the development of oral insulin and expects to launch it in 8 to 10 years.
In the first half of 2016, Novo Nordisk completed the phase IIa clinical trial of the oral insulin program OI338GT, and published detailed clinical trial data of IIa in 2017ADA (American Diabetes Association Scientific Annual Meeting) and EASD (European Association for the Study of Diabetes Annual Meeting). OI388GT is as effective as Sanofi injection of Lantus in controlling blood glucose levels.
Regrettably, Novo Nordisk announced the termination of the OI338GT study as early as October 2016, and the official reason was "due to the consideration for the high 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 capacity, capacity pressure is not small, for cost considerations, terminated the project.
Dr. Mads Krogsgaard Thomsen, Chief Scientific Officer at Novo Nordisk, said in a blog post that the company still believes in the potential of oral insulin.This cooperation with MIT and other institutions, it can be seen in the field of undead heart.
Novo Nordisk is not the only one in the field of "oral insulin".In 2017, Sanofi entered into a research agreement with Enteris BioPharma to use the latter's oral dosing platform for the treatment of type 2 diabetes.
Oral Insulin Capsules ORMD-0801 from Oramed, Israel is already in Phase II clinical trial.On 13 November 2018, Oramed announced that it had successfully randomized more than 50% of the expected 285 patients to the 90-day dose-ranging Pivotal Phase 2b clinical study of ORMD-0801 to generate meaningful data for efficacy and safety endpoints.
3.Can it revive Novo Nordisk's high long-term growth?
Probably more than a decade ago, inhaled insulin was a popular direction.Only because of lung safety issues, drug absorption stability and other issues, inhaled insulin products are not the market.
One of the most promising in the beginning was Pfizer's pioneering Exubera, which had been forecast to peak at $3 billion but sold only $12 million in the first year.And then it's out of the market.
In the eyes of the industry, some of Exubera's failures are related to the device's awkwardness.Sadly, Mannkind later launched Afrezza, a more sophisticated inhaled insulin, but its absorption is still slow.
Due to the intensification of competition in the diabetes market and price pressures, Novo Nordisk has to get rid of its dependence on traditional insulin injection products as soon as possible.Just a few days ago, Novo Nordisk announced its 2018 earnings report (see Novo Nordisk 2018 earnings report: liraglutide revenue surged 73% in China, oral semaglutide 2019Q1 application for listing) showed that the global market share of insulin accounted for nearly half of the increase in insulin only 0. 5%.5 percentage points.
For this reason, scientists at Novo Nordisk MIT are working to optimize the manufacturing process of this product, and through further studies to determine the long-term effects caused by daily gastric injections.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 people with diabetes who are currently treated only with injections or infusions.Scientists say the platform can deliver not only insulin but also a wider range of biological agents that traditionally have to be injected, including peptides and nucleic acids, such as DNA and RNA therapies.
This turtle-inspired oral insulin capsule can help Novo Nordisk return to a long-term era of high growth?Because it has not yet entered clinical trials, there is not enough human data to verify its effectiveness, and we can only wait and see.