UK-based Arecor targets vast artificial pancreas market with fast insulin and stable glucagon. Wait; artificial what?

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The News:

UK biotech Arecor Ltd. (Cambridge) has raised $7.8 million (€6.7M) to help fund development of its extra-fast insulin and stable glucagon products for people with insulin-dependent diabetes.

The speed of action of insulin has been a limiting factor for development of the artificial pancreas–a combined insulin pump and glucose monitor that would allow real-time control of blood glucose. This technology is eagerly awaited by people with insulin-dependent diabetes, as an efficient system would eliminate the need for multiple daily injections and risk for hypoglycemic attacks.

Insulin injections currently take 10-30 minutes to have an effect, depending on the formulation. The perfect artificial pancreas would need to be able to raise or lower blood glucose in minutes, so for such a system to work well, there is a need for super-fast-acting insulins, says Labiotech.

According to Arecor, it has developed an insulin that has a “considerably more rapid onset compared with currently marketed rapid-acting insulins” and it is planning to target the developing artificial pancreas market.

Another important component of an effective artificial pancreas is glucagon, which counteracts the effects of low blood sugar due to overly high insulin dosing. However, solubility and stability have been a problem in the past. Arecor is also developing an aqueous, stable glucagon for this purpose that can also be used as an emergency rescue injection, something French biotech Adocia SA (Lyon) is also working on.

Arecor said it plans to use the investment to test its new products in humans and to develop stabilized, more efficient versions of a range of drugs for different indications.

The race for the ultimate artificial pancreas has not yet been won, although the technology is getting closer and closer. Current frontrunner Medtronic has a closed loop system on the market, but it is not yet fully automated. There are also a number of other competitors around the world including French biotech Cellnovo Group SA (Paris), among others.

Steve’s Take:

After reading the foregoing report about Arecor’s latest raise, I found myself trying to picture an “artificial pancreas.” And I must say that after decades working in the medical field, I was quite stunned to learn I had virtually no factual knowledge about such a thing.

Was it an actual implantable, mechanical device, along the lines of an artificial heart? Was it made from the pancreas of a sheep, cow or pig? Yet the news report was a serious one wherein Medtronic Inc. (Dublin IRL) is portrayed as in the lead developing the device.

With copious borrowing of the insights of Margaret Ebmeier, who writes for Taking Care of Your Diabetes (TCOYD), I gained a quick lesson on this topic–again, about which I knew far less than I thought–starting with this device called an artificial pancreas.

So with my apologies to the nearly half billion people currently living with diabetes around the world…first of all, what the heck is it?

The artificial pancreas (AP) is a device that mimics the blood sugar function of a healthy pancreas. It has three parts: a sensor for continuous glucose monitoring (CGM), a pump to deliver insulin, and a laptop or cell-phone component that directs the pump to deliver insulin as needed.

Most systems will deliver insulin alone, but some will be able to deliver both insulin and glucagon.

How it’s different than CGM?

AP systems are often called “closed loop” because they talk to both the sensor and the pump, bridging the gap between the two. The goal is to make a continuous loop without the need for human intervention. In testing so far, AP systems have often resulted in more time in target glucose ranges with less hypoglycemia, and they have also excelled in controlling blood sugars overnight. They are not a cure by any means, but they are a huge improvement and will allow for diabetes management to go a little more on auto pilot in the near future.

50 years in the works

The first precursors of the artificial pancreas date back to the 1970s. In the 50 years since, improvements have been made on all fronts: control algorithms are getting more predictive and less reactive, and pumps and glucose sensors are getting more accurate. Yet many challenges remain, such as the need for faster insulin, more stable glucagon, and systems that can work without user intervention, e.g. during meals and exercise.

The future is nearly now

In June of 2017, Medtronic launched the first commercialized AP product, Minimed 670G.

The Medtronic device is a “hybrid” system due to the need to manually interact for meals and exercise. Hailed as a major advance towards a fully automated artificial pancreas system, the 670G will be followed by other closed loop systems in the coming months and years, with more and more academic group and industry collaborations being announced. One such effort–the IDCL (International Diabetes Closed Loop) Trial–is another example of the degree of collaboration between academic centers and industry.

Led by the University of Virginia in conjunction with centers in Europe, companies like TypeZeroTechnologies, Tandem Diabetes CareDexcom and Roche Diagnostics are also involved. Other companies like Insulet (Omnipod) and Bigfoot are developing AP systems as well.

As a result, Ms. Ebmeir believes, “We can expect several artificial pancreas options in the coming years. Systems will differ but the goal will be the same: to reduce the burden of living with diabetes until a cure can be found.”

Fortunately, I have a friend who has been insulin dependent for decades and had come here recently to attend the TCOYD conference for adults with Type 1 diabetes. My line of questioning to her went something like this:

“Is this artificial pancreas something that people like yourself are wildly enthusiastic about and have been awaiting forever and could be around the corner? Or is this product years away? I thought that having attended the conference here in SD, you might have a realistic take on this, as there is so much excitement and coverage in the media.”

My thanks for her perceptive response: “This ‘closed loop’ artificial pancreas” system does seem to be a real thing. I do have a hard time believing that the market will be ‘huge’ [because] aren’t we Type 1 diabetics in the vast minority…?  The statistics say that only about 5% of diabetics have Type 1. (Most Type 2s don’t need an artificial pancreas. But if in fact there is a good market for it, it will radically improve the lives of insulin-dependent diabetics.)

She added: “I guess my basic response is to be cautiously optimistic. I’ve been hearing for 40 years that a cure is ‘just around the corner.’ However, it does seem that real progress is finally being made.”

Whew! That was prescient, and fraught with insightful comments and questions for potential investors to ponder.

Bottom Line:

Which brings us back to Arecor. Let’s take a quick look at where the company stands in this high-stakes race to improve the quality of life for so many people around the world.

The equity investment of £6 million in Arecor was led by UK institutional investors Calculus Capital, Downing Ventures, and Albion Capital with significant participation from Arecor’s existing backers, says Business Weekly.

The International Diabetes Federation estimates that there are nearly half a billion (425 million) people currently living with diabetes around the world and adds that if the global direct and indirect healthcare costs from diabetes are included, the economic impact of the condition exceeds $1 trillion.

Arecor chairman Dr. Andy Richards told Business Weekly:

“Arecor has been a growing success story over the last few years under CEO Dr. Sarah Howell’s leadership. This fundraising also signals that you can make real therapeutic progress without always raising 10s of millions, by being smart and focused.”

While Arecor will be taking its product portfolio into clinical development itself, it will ultimately look to partner with specialist diabetes companies for late stage clinical studies and global market access.

Arecor has established a proven track record in applying this technology platform to deliver superior biopharmaceutical product profiles across a broad range of therapeutic areas.

In my opinion, Arecor is a company to watch. It’s extremely early in the development of its products. But it’s data, presented in San Diego, and recent funding raise, suggest strongly that this is a company on the track to either tremendous sales growth (albeit not next week, to be sure) or a buyout by one of the biggies at a monstrous premium to its investors. Stay tuned.

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