Most press releases I get (sometimes over a hundred a day) are pretty dull, but a recent one from research and consulting firm GlobalData piqued my interest enough to survive the DEL key treatment.
It confirmed that two coeliac drugs are expected to enter the European market in early 2019 and early 2020 respectively (each a year earlier in the US).
Larazotide acetate will be the first. Developed by Alba Therapeutics, founded by internationally renowned coeliac voice Dr Alessio Fasano – author of the brilliant Gluten Freedom – it works by making the gut less ‘leaky’ to gluten peptide molecules. It is not expected to allow deviation from a gluten-free diet, but to act as a complement to it – to help prevent the effects of accidental cross-contamination when eating out, or offering protection against the low-level gluten ingestion coeliacs almost invariably live with.
The second is latiglutenase – ALV003 by Alvine Pharmaceuticals – an enzyme rather than a drug, per se, and one devised to break down gluten proteins into harmless fractions in the small intestine. Research has shown that enzymes are the preferred form of treatment for coeliacs.
The two could, potentially, act complementarily.
GlobalData analysts predict the launches of the two treatments could see a market value of $550 million by 2023 ….
Thoughts? I find these (and the many other) treatments in development revolutionary – often the science is cutting edge – but I perhaps have reservations concerning the monies involved, and how these treatments are eventually marketed to coeliacs. They seem to me to be more of a security blanket than a necessity, and eventually I’d like to think we’ll have reduced cross-contamination incidents in restaurants and in foods thanks to better awareness, the upcoming new labelling legislation, and perhaps more sensitive allergen detection tests – but perhaps that will never be completely satisfactorily achieved. They may be useful when travelling to coeliac-unaware countries, too, I guess.
I know some coeliacs are deeply against the idea of drugs for a disease which has an effective treatment already – the gluten-free diet – but the research being done could have implications for other diseases and autoimmune conditions, so – with my usual disclaimer here that I am not speaking as a coeliac – I’m excited by this research, and that it is moving forward, and that the timeframes are now on the horizon.
Despite the dissenting voices, I know there are many coeliacs out there who do want additional and complementary treatments to the GFD … Are you among them? Or are you dead against drugs? Or vaccines, which is another option being looked at?
Very interesting times! I have worked in (alongside) the pharma industry as a consultant for a number of years so have a couple of thoughts as to what this might mean for us coeliacs.
Firstly, I would expect that (depending on the price point) we might expect some resistance to approval for the first drug on the NHS – it seems that they might struggle to demonstrate a benefit to patients above and beyond sticking to gluten free diet. In economic terms, I believe the NHS is probably rarely troubled by the 'accidental glutenings' that many coeliacs complain of – its often a couple of days at home with some peppermint tea rather than a trip to the GP or hospital – so potentially little financial benefit, and limited quality of life benefits compared to the potential outlay. They will be under pressure to demonstrate a 'real world benefit' to the treatment. (I don't mean to downplay, I know some suffer very badly, but this is what I have seen most of).
They will also find it very hard to educate patients to encourage them to stay compliant with the treatment regimen – you'll either get people viewing it as a carte blanche to eat the odd slice of toast (or get a bit more lax with the shared butter) and potentially put themselves at risk, or if you remain asymptomatic there's little impetus to take a daily pill (assuming that's how the treatment works).
The other treatment is potentially more interesting – they will need to demonstrate a financial benefit as well as a quality of life benefit to NICE compared to the existing treatment (a gluten free diet) so let's see what price they come in at! Either way I can imagine the NHS will find this more appealing than the current regime – take a pill is easier to explain than the ins and outs of a gluten free diet. I put some ideas down about how the NHS make these kinds of decisions a while back: http://glutenfreeb.com/2012/11/14/if-bread-was-a-tablet-would-the-nhs-prescribe-it/
Both companies may have to 'prove' the treatment is working by offering alongside regular screening tests for patients to ensure antibodies aren't raised or villi aren't damaged.
Either way I think we can expect things to change for us as patients. As I mentioned on twitter, pharma companies can't promote directly to patients in the EU (although they can in the US and there's nothing much to stop us getting hold of the same websites/media as our US counterparts) but we can probably expect money from the pharma companies to be put behind patient and physician education about coeliac disease – how to spot/diagnose it and manage it. This can only be a good thing – whether or not people end up on the treatment. We can probably expect more people to be diagnosed, and potentially even screening of patients with IBS to take place in some areas.
The companies may be keen to work with organisations like Coeliac UK and recruit prominent GIs and vocal tweeters to work with them – either in market research, or to act as 'experts' to present their research. Expect Gluten Dude and Jennifer Whatshername to be treated with velvet gloves! We might see the companies sponsoring events or publications.
Also, worth noting both are pretty small Pharma Co.s/research organisations so we might yet see these treatments bought or contracted out to a larger player in the GI space.
Would I take it? For me it would depend on the reliability – I'd like to see the data first! But to be honest, I've spent so many years now educating myself how to manage the disease and my diet, it'd be hard to change back. It would be wonderful to have the option though, and if I was newly diagnosed it would be a no brainer – these are likely to be initial targets for the treatment (or those that haven't healed on GF diet).
It does seem a bit strange though, that our relatively modern wheat-heavy diet is poisoning a large segment of the population, and our answer isn't to change the diet, but change the people.
Another thought – I have assumed these would be prescription treatments, it may be that they end up being over the counter – which is a whole other kettle of fish involving whole loads of issues around marketing, self-diagnosis and all sorts…
If Dr. Fasano (a man I have met and whose work I greatly admire) backs a drug that will help me when traveling to potentially ward off a chance encounter with trace gluten, you can be sure I'll keep some on hand. I suffer for a few weeks from a gluten hit, so a proven prophylactic measure would make me feel more comfortable and less worrisome while dining out.
My biggest concern is that people will use the drugs as a way to "cheat" which would, of course, cause a variety of problems should they continue to ingest gluten.
Fascinating insight into how it might work – thanks for posting it, Carly. Interestingly – re: your final comment – there are some potential solutions that change the diet rather than the people – GM'ing a wheat that eliminates the key toxic peptides, for example. Controversial to many, I know …
Well, in fairness, one of them is his own drug, so he would back it and clearly has a vested interest in it! But that said, I think his ItalianHeart is in the right place! 😉 – by which I mean, he's sincere and dedicated.
And yes, that is a concern – that it becomes a free ticket to risky behaviour or out-and-out GFD abandonment. It would have to be managed carefully …
Oh yes! That is why I said his name in connection with the drug. He has stated openly that he is one of the team that is researching and developing the drug and that is especially why I love the guy. He is truly a doctor who has all celiacs' best interests at HEART. 😉
Will these treatments be effective with non-gluten wheat proteins, which are coming under scrutiny? article with some information at http://www.medicalnewstoday.com/articles/284990.php
Very interesting question, Anne. I suppose the enzyme won't be, because it has been designed specifically for gluten. (That said, there may be other enzymes to tackle these other proteins – perhaps they already exist, or could be developed.) I don't know enough about the 'anti-leakiness' drug to comment, but my guess would be that yes, it's possible, as it basically 'shores up' the defences of the gut lining. The scientists do say it could have other applications. I would say though that the non-gluten wheat protein issue needs a lot more work to confirm the suspicions of that study – although I did find it very interesting …
I like the idea of the leaky gut target drug (with all the caveats everyone else has said) but I don't get the enzyme med proposal as those already exist – there are plenty of gluten enzymes already on the market. I wonder what makes this any different.
Those OTC gluten enzymes have not really been proven as being effective. None of these products has undergone any sort of clinical trial or testing to assess efficacy and safety in people with celiac disease and non-celiac gluten sensitivity (NCGS). Some of these formulations have probiotics, and others have vitamins and minerals something many gluten intolerant patients are deficient in such as: B vitamins, vitamin D and iron. Taking those supps may make someone feel better, but the actual amout of gluten molecule that's being "digested" is anyone's guess as there is no data to support the claims.
Yes, I think IrishHeart has said it. Glutenzyme has not undergone long-term clinical trials. Enzymes have to not only break gluten down, but break it down to protein chains which can't trigger the immune response. I presume it's a very specific and targeted action, that has taken years of research to get right …