Top Secret? Promising New Insulin Pill

I had the most absurdly frustrating phone briefing yesterday with a company developing a very promising new technology for delivering insulin in an oral gel cap: Oramed Pharmaceuticals based in Jerusalem, Israel. Oddly, I was contacted by their PR/Investor Relations firm with the express purpose of “getting the word out to the public,” but trying to pry any of the key details out of their execs felt a bit like talking to the Israeli Secret Service. Nada.

Afterward, the IR guy apologized, and noted: “Yeah, they’re pretty secretive. Their formulation is soOramed_pharmaceuticals_inc simple that they’re afraid it could be easily replicable.” OKAY…

I’m only telling you about all this because Oramed’s product really does look promising, as opposed to other attempts at oral insulin that haven’t quite panned out (think Exubera, and at least two other insulin tablets that appear to be stalled in development, Intesulin and Emisphere).

Here’s what I could surmise about Oramed’s stuff, mostly from their web site, this slick presentation, and their recent press release:

* “Up until now, the idea of insulin pills or tablets was inconceivable due to the fact that insulin, which is a protein, breaks down in the digestive system.” However, Oramed’s patented technology overcomes this barrier by “mimicking the physiological entry of insulin into the bloodstream by bypassing digestion in the stomach. It is absorbed through the intestines, and is filtered and regulated through the liver into the bloodstream.”

* The company has struck an advantageous deal with Swiss Caps AG, one of the largest softgel capsule manufacturers, in which this manufacturer requested equity in exchange for their services. (A strong endorsement for Oramed’s future success — who wants equity in a company that won’t hit it big?)

* They’ve completed successful Phase 1A human trials in Israel, albeit it with healthy, non-diabeticPill_in_hand_2 subjects. But the effect on insulin, glucose, and C-peptide levels were “quite significant” without any negative side effects. According to Dr. Miriam Kidron, pharmacist and biochemist behind the product, it’s very difficult to show these type of results in people without diabetes, so Oramed supporters are very encouraged.

* They hope to complete Phase 1 studies in the US by mid-next year. Meanwhile, they’ll begin Phase 2 trials with diabetic patients in Israel in the next few months. These studies will not count directly toward the FDA approval process (which will go significantly slower due to stringent regulations), but will rather expedite development and launch of the product in countries like South Africa and South America within about year and a half if all goes well.

* Making their way through the stringent FDA approval process will probably put off market launch in the US until about 2010. (Hey, if it really works, I can wait)

* As of now, the tablet is used “more similar to a bolus, but could also be applied like a basal insulin, as a once-a-day dosage.” Wait, what does this mean? This is where things got confidential. Actual dosage and usage details are still top secret, apparently. Hmmph.

btw, Oramed is also developing future flu pill to replace the flu shot, helping to rid medicine of more needles.

But Dr. Kidron is patient-savvy enough to note that most PWDs who use needles aren’t all that desperate to get rid of them. “The advantage of oral insulin is not to avoid injections, but to mimic the natural way insulin is absorbed. With filtering through the liver, everything you eat will be absorbed by delivery,” she says.

What exactly does that mean? I’m afraid they’re not comfortable talking about it publicly just now. Guess we’ll just have to stick to our usual modus operandi: wait and see…

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19 Responses

  1. sri
    sri October 25, 2007 at 7:15 am | | Reply

    There’s another company based out of Bangalore, India, working on an oral pill. They are starting Phase I trials in Europe. Here’s a link to the press release: http://www.newsgaze.com/26-BIOCON.html

  2. Anne
    Anne October 25, 2007 at 7:48 am | | Reply

    “With filtering through the liver, everything you eat will be absorbed by delivery.” Huh?

    I don’t think I would replace my pump, even with oral insulin, unless I was able to control the dosing as carefully. At this point, I don’t see how that would be possible.

    If the oral insulin actually works better, though, it may be a different story. I don’t want to be popping 100 pills a day though…

  3. Scott
    Scott October 25, 2007 at 8:31 am | | Reply

    In addition, to India’s Biocon, the Connecticut-based startup Biodel, Inc. also has an oral insulin product in its pipeline called VIAtab.

    The company has received some press this year because of its presentations made at the ADA and the EASD regarding its VIAject injectable insulin, which is slightly faster than today’s analogs yet remains structurally identical to regular human insulin.

    VIAtab is an oral formulation of insulin designed to be administered sublingually, meaning a tablet that dissolves in minutes when placed under the tongue. However, this product is not as far in clinical trials as VIAject, and likely has several more years of clinical trials before seeing an FDA application.

    The bottom line seems to be that a number of companies are working on this, and yes, oral insulin could be the next Exubera. But we should be asking whether this has potential to do any better? A lot will depend on how well the company knows the market, and for that, it does appear they are better than Pfizer was, but then again, everyone is hoping to avoid Pfizer’s numerous mistakes. Only time will tell …

  4. David Locke
    David Locke October 25, 2007 at 9:05 am | | Reply

    The stringency of the FDA approval process has not changed. It was made shorter by fast tracking for AIDs related drugs, which spread to all drugs. A result of this fast tracking are meds that kill or injure as a norm.

    Genome-suspects are invested in and put into case studies to discover what can be claimed, so the stuff can be sold. This process is not based on any knowledge of the underlying physiological processes. It amounts to throwing stuff against the wall to see what sticks.

    The FDA process probably needs to get slower, rather than faster.

  5. Tom
    Tom October 25, 2007 at 9:29 am | | Reply

    I actually think this idea is a pretty good one, even though I will probably still prefer my pump. For kids, however, oral insulin could be money in the bank.

    As per the bolus idea, when I read that, I imagined “Okay, the green pill is 1 unit, the yellow pill is 5 units, and the red pill is 10 units. I need twelve units, so that’s a red and two greens.” :-p

    While this route of oral insulin delivery has flopped in the past, I feel like these guys know what is going on.

    As a side-note, Amy, I’ve been meaning to thank you for your book. I had it sent home instead of to my apartment at college, but I should be reading it by the end of this weekend. Thanks!

  6. Kevin
    Kevin October 25, 2007 at 9:37 am | | Reply

    What about people w celiac, especially undiagnosed celiac, chrohn’s and other intestinal issues? According to a comparison of diagnosed celiac in the US (1:4500) vs diagnosed celiac in Europe (1:250), there will be a lot more people here than you would guess who won’t be candidates for anything that gets absorbed via the intestines due to variability of absorption leading to poor results. My guess anyway.

  7. Bennet
    Bennet October 25, 2007 at 9:44 am | | Reply

    “But we should be asking whether this has potential to do any better?”

    Stop making sense.

    How will we get the next Bongubra if we insist on new products that are actually better not just patentable as different?

    Seriously, great point. It should be painted on the walls of every drug company board room.

  8. Jenny
    Jenny October 25, 2007 at 10:49 am | | Reply

    I’m shaking my head wondering how powerful an insulin could be that you can give to people who don’t need insulin.

    I have normal insulin sensitivity and even 1 unit can make me drop too low if I don’t match it with carbs.

    So while this stuff might be harmless, I have to wonder how powerful it is.

    I think the liver comment relates to the fact that homemade insulin goes into the portal vein and instantly into the blood stream. So if you had a truly physiological insulin, it would do the same, however, you’d still have the problem that if you missed the food the extremely fast insulin would drive you much too low.

    Slowness of “insulin on manual” is good because it gives you time to react as blood sugars drop. That’s why I like R better than Novolog for larger doses. Yes, I have to wait to eat but if I get the carb count wrong there’s a gradual drop rather than a sudden drop.

  9. Jim
    Jim October 25, 2007 at 11:34 am | | Reply

    We need to be very cautious about getting excited by these folks; they are using the Blog to start generating “buzz” without having to answer any specific questions – if everything is supposed to be so “secret” then why do they have PR people contacting blogs?

    This is just a start-up taking advantage of diabetics really eager to get some help.

    There is a “gotcha” here, bet on it. “Yeah, they’re pretty secretive. Their formulation is so simple that they’re afraid it could be easily replicable.”

    ???? As PT Barnum once said…..

  10. Penny
    Penny October 25, 2007 at 11:48 am | | Reply

    Hmmm. I can’t wait to hear if this actually pans out or not.

  11. chris
    chris October 25, 2007 at 12:18 pm | | Reply

    Can a pill like this be used for Type 1, instead of using a pump? I have been confused about things like this and Exubera. Do Type 1′s on the pump have any hope of these things helping?

  12. mcityrk
    mcityrk October 25, 2007 at 12:48 pm | | Reply

    Hi All-

    If the pill has to clear the stomach and reach intestines before gel dissolves and absorption uptake occurs, doesn’t that imply incredibly unpredictable time-lags before any medicinal benefit happens and how can you possibly match your food intake to this bizzare insulin delivery pattern????

    mcityrk

  13. Karen
    Karen October 25, 2007 at 3:35 pm | | Reply

    I know what’s going on!!! I really do! You see…this company “Oramed” feels so badly about Pfizer’s multi billion fall from grace..that they have decided to take the heat off them by making another DIASTER. Can’t wait to see how much money goes down the drain with this one…

  14. whimsy2
    whimsy2 October 25, 2007 at 8:54 pm | | Reply

    If you’re a type 1 (or 2) not on the pump but matching insulin dose to carbs in meal, with variable insulin dosing (like me) an insulin pill would be totally useless. Where’s that closed loop system???

  15. Michelle
    Michelle October 26, 2007 at 7:32 am | | Reply

    Even for kids, I wouldn’t bother with this. I’d have more success getting my cat to swallow a pill.

    products like these I think are really just marketed to that population of Type 2 folks who are being threatened by their dr’s with the *gasp* possibility that they will have to take insulin. I hate that dr’s use it as a threat. But many of those folks want something easier and possibly a once a day pill would be good for them.

  16. Felix Kasza
    Felix Kasza October 26, 2007 at 10:58 am | | Reply

    Personally, I’ll miss The Bong. :-)

    To the poster who asked how effective an insulin can be that you can give to healthy people without making them crash: This is how insulin analogs are initially tested, too. The method is to either keep the dosage small and let the body’s glucagon system handle the matter; or to feed volunteers, give them insulin, and measure (via C-peptide) how much less insulin the body produces on its own to balance the carbs; or to hook volunteers up to an euglycaemic clamp — a double infusion of glucose and insulin, with a feedback loop to keep BG stable — and to watch how much glucose the system needs to infuse to keep BGs stable against the insulin being tested.

    Cheers,
    Felix.

  17. BillyWarhol
    BillyWarhol October 26, 2007 at 3:02 pm | | Reply

    Hopefully a “Real” Cure appears within our Lifetimes* Just read this bit from CNN on da Pump + closed Loop system http://tinyurl.com/359uxq

    To my mind not even close to a Cure – better Control but still a Rigamaroll*

  18. KR Dasharathi
    KR Dasharathi October 28, 2007 at 9:52 pm | | Reply

    Is is good news. But the pill should be made available within few months as lodt of diabts are eagarly wailting. They can try it out n other countries where regulations are simpler and people accept a certain amount of risk.
    Dasharathi

  19. DR Lowe
    DR Lowe June 17, 2008 at 8:27 am | | Reply

    Oramed is working on a Insulin suppository for toddlers and capsule for adults.

    The theory is solid and simple: Put your ideas of sensitivites to dosages and diet aside intially – diet is always going to be important factor. The liver will regulate the insulin in your bloodstream provided it has enough of it from the pancreas and barring that as long it has suplimented insulin by another form such as oral delivery. The holy grail has always been delivery of insulin into liver as opposed to directly into bloodstream. Life as a diebetic is difficult – in the main because you’re injecting insuling directly into your bloodstream which in itself opens up a large range of problems and which has created a multi-billion dolllar ancillary industry.

    What Oramed is doing/trying to do has not been done before, but at the very least they have a great pedigree, being Hadassah in Jerusalem. They are in trial and the FDA makes them test healthy volunteers before diabetics. Test on healthy people showed that there was delivery of insulin into liver via oral capsule. That part of it shouldnt be any different on diabetics – a diabetic’s digestive system is going to do the same thing.
    Whether its Oramed who does this or someone else, its the right strategy and hopefully diabetics will have a very positive life change as a result.

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