2018 could be an incredible year for patients in the diabetes space. A number of fresh treatments have either picked up approval at the end of this year (and, in turn, are due to launch early next year) or will be subject to late-stage investigation and seeking approval during 2018 and each of these fresh entrants has the potential to turn the current standard of care (SOC) regimens (which, in diabetes, are notoriously unpleasant) on their heads.
Here's a look at three drugs that fall into the above categories.
First up, Semaglutide.
This one picked up approval from the FDA in the US back on December 5 and is a Novo Nordisk (CO:NOVOb) drug. For those not familiar with the current state of the diabetes treatment space, there are basically two types of therapy.
One is direct insulin therapy, which involves (normally) intramuscular injection of insulin into the body, with the goal being to top up insulin levels ahead of times at which glucose levels are likely to peak (mealtimes, for example). The insulin gets to work reducing glucose levels and returning the patient's blood sugar to normal.
The other is rooted in what's called GLP-1, which is a hormone that stimulates insulin production and, at the same time, induces the feeling of satiation in individuals that take it. It's into this category that Semaglutide fits.
Semaglutide is an agonist of the GLP-1 receptor (meaning, essentially, it makes it work harder than it would otherwise without stimulation) and, in turn, increases the rate of GLP-1 that the body produces.
So, the FDA approved the drug based on what amounted to some very solid late-stage data (across more than 8,000 patients) that showed not only can it help lower blood glucose levels but that it can also induce weight loss when used as an adjunct to diet and exercise and – and here's an important point – it's a once weekly administration.
Compare this to the three or four times daily administration of insulin that patients have to undergo right now and it's clear why this one could be a game changer for the patient population.
Next up, ertugliflozin.
Ertugliflozin is the generic name for what Merck & Co. (NYSE:MRK), the company behind it, intends to call Steglujan commercially. This one literally just picked up approval and, just like Semaglutide is due to hit the shelves in the US at some point during the late first quarter or the early second quarter of next year.
Unlike Semaglutide, however, Steglujan is what's called a sodium-glucose co-transporter 2 (SGLT2) inhibitor. This one's a pretty novel approach to treatment. Basically, SGLT2 is what's responsible for glucose reabsorption in the kidney. The idea behind Steglujan, then, is that by stopping (or at least lowering the level of) glucose that gets reabsorbed in the kidney, you can lower the levels of glucose that end up in the bloodstream at times of peak glucose – meal times, etc.
To put this another way, the drug makes patients extract glucose in their urine instead of absorbing it into the bloodstream. The commercial asset also includes ertugliflozin as an adjuvant-type asset, which is what's called a DPP-4 (dipeptidyl peptidase 4) inhibitor. These drugs reduce glucagon and blood glucose levels by increasing incretin levels.
Essentially, then, it's a two-pronged approach and it allows Merck to go head to head with a blockbuster drug called Glyxambi, which has a more rigorous dosing regimen, giving Merck's asset the advantage.
Finally, ORMD-0801.
This one is the development stage addition to this list. The company that's developing the drug is called Oramed Pharmaceuticals Inc. (NASDAQ:ORMP) and it's trying to bring ORMD-0801 to market as an oral administration alternative to the current SOC assets in this space.
Oral insulin has long been just out of reach for the diabetes population and – to date – no company has figured out how to get the incredibly fragile insulin through the GI tract and to the liver without it being broken down and – in turn – rendered unusable.
Oramed has developed a proprietary capsule-type technology that uses protease inhibitors to block the effect of the enzymes in the body that would normally break down the drug before it reached its destination.
The drug scored some pretty strong data in a wide-reaching phase II trial last year and the FDA just gave Oramed the green light to kick off a phase III trial, which is slated to start any day now.
If the company can prove that its drug can help contribute to lowering blood glucose then it could serve as both a boost to current SOC and, at the same time, a sort of bridge drug that physicians can prescribe to pre-diabetics ahead of the injectable SOC options.