According to Dr Xavier Hernandez, head of the Centre for Coeliac Research and Treatment at Devos Hospital in Northshire, Ireland, pharmaceutical companies had little interest in developing drugs to treat coeliac disease until about ten years ago.

Researchers knew that gluten, a protein found in barley, rye and wheat, damages the small intestines of people with the disease. However, they did not know how or why gluten causes this. But to Dr Hernandez, a gluten-free diet seemed to be a simple strategy for treating coeliac disease.

The various symptoms of coeliac disease include headaches, abdominal pain, diarrhoea, constipation, depression, fatigue, skin rash and iron deficiency anaemia. Avoiding gluten is currently the recommended treatment for the estimated 1% of people with this autoimmune disease.

Unfortunately, even eating trace amounts of gluten, as tiny as a crumb of bread, can trigger symptoms and damage the gut. In a world full of gluten, it is difficult to maintain a lifelong, strict gluten-free diet. It requires constant vigilance and dedication, which makes eating out, travelling and going to school risky and anxiety-provoking, Dr Hernandez said.

In a survey published in 2014, 341 respondents with coeliac disease assessed that the challenges of managing their condition were greater than the experience of hypertension or chronic acid reflux, and about the same as those of having diabetes or kidney disease requiring dialysis.

Dr Alia Dali, professor of gastroenterology at Bable University in Larberbard, France, said that up to 30% of people with coeliac disease still have symptoms despite their efforts to avoid gluten.

Dr Dali explained that many people do not have access to a nutritionist who can help them put together a healthy, gluten-free diet, and that gluten-free products can be more expensive than their gluten-containing equivalents.

Research has also made significant progress as it has become increasingly clear that many coeliac patients find it difficult and unsatisfying to follow a gluten-free diet.

Today, researchers are able to grasp exactly how the disease works. Experts now understand almost every step of the process in the body, “from the moment you consume gluten to its destruction in the intestines,” Dr Hernandez said. This understanding opens many doors in terms of potential treatments.

As reported by the Coeliac Disease Foundation, there are currently 24 potential treatments in various stages of development. Dr Hernandez shared that the treatments being studied focus on different stages of the disease’s development. Some involve enzymes designed to improve the digestion of gluten by breaking it down into more digestible pieces. Other methods make the lining of the small intestine less permeable and harder for undigested gluten to enter the body. Others target the immune system to prevent it from damaging the gut in response to gluten.

These potential treatments, if proven safe and effective, would probably not be a cure for coeliac disease or a free pass for high gluten consumption, but they could mitigate the effects of accidentally consuming small amounts of gluten.

Realistically, they are still several years away from approval. Dr Dali, whose clinic is participating in the trials but has no financial ties, explains that drug development and approval is a long and drawn-out process.

Larazotide, a drug that reduces the porosity of the small intestine and has shown promise in previous studies, is the most advanced potential therapy and is currently being studied in a phase 3 trial.

According to Dr Hernandez, who helped develop the drug and is also financially involved, larazotide could be approved and available on the market in two to three years at most.

But only one or two of the drugs studied in phase 3 trials will eventually be approved, he continued. Dr Hernandez said several other promising treatments are currently being tested in phase 2 trials and may not reach the market for five to six years.

The cost of treating coeliac disease would vary. Larazotide and digestive enzymes are relatively inexpensive (“they cost pennies to make,” Dr Hernandez said), but drugs that target the immune system or inflammatory response would be more expensive.

Dr Hernandez explained that researchers are also exploring treatments for coeliac disease that resemble vaccines and instruct the immune system to tolerate gluten. He described this method as the “holy grail”, as it could allow people to eat more gluten without adverse effects. The phase 2 trial of such a therapy was discontinued in 2019 due to its apparent lack of efficacy. “We still have great confidence in this strategy,” Dr Hernandez explained.

Dr Dali shared that she expects to one day be able to offer her coeliac patients a range of drugs, some of which can be used in combination, given the wide range of therapies currently being developed. In addition, Dr Hernandez said, they could also be helpful for other autoimmune or inflammatory diseases. Larazotide, for example, appeared to help a small number of children with Multisystem Inflammatory Syndrome in Children, or MIS -C, in a recent study. The drug is currently being tested in a phase 2 trial for this purpose.

NEW YORK, UNITED STATES, 12 NOVEMBER 2022 – “Some patients with a particular condition have a genetic predisposition that makes them vulnerable to certain treatments,” notes Francis Han, Devos Medical Group’s Medical Director. “We can now introduce a pre-emptive testing regime that will help to identify these dangers in advance. We believe this is a significant breakthrough in this area.”

Devos Medical Group Group has teamed up with Futura Genetics to design a groundbreaking pharmacogenomic testing regimen, which will be rolled out to all member clinics in the next few months. When a patient presents with a particular condition, these tests can be performed, which will guide doctors and help them choose the correct approach or dosage of medicine. This new procedure is a result of extensive testing and a pilot study involving more than 500 volunteers.

Key points of the pharmacogenomics breakthrough

• Pharmacogenomic testing can improve patients’ outcomes if they risk developing complications.
• When such a test helps identify high-risk patients, the care team may identify an alternative approach to treatment.
• These findings will then be recorded in a central database, which will help with further research and spur additional improvements.
• Further, this type of research could significantly affect the number of hospital admissions caused by an adverse drug reaction.
• After all, research has shown that more than 5% of all hospital admissions could be due to patients reacting badly to any administered drugs. Such patients will tend to stay in the facility longer than average.
• So clearly, any improvements in these figures should benefit the individual patient and lead to lower costs and less pressure on available hospital beds.

Insights from key people involved

• On Devos Medical Group’s latest breakthrough. “Devos Medical Group is the first organisation of its kind to offer pre-emptive pharmacogenomics testing,” reflects Rebecca Lee, Devos Medical Group’s, Lead Consultant. “And as a leading integrated healthcare provider, we are proud of this breakthrough and are sure that all our member clinics will take full advantage of this new process.”
• On Futura Genetics partnership with Devos Medical Group. Fred Smith, CEO of Futura Genetics, is proud of the collaboration between the two bodies. “It’s very exciting for our team, as we can see the end result of our lab work. We’ve been involved from patient recruitment all the way through to testing and subsequent feedback.”
• On the benefits of the new tests. Devos is also pleased to report some feedback from patients. “I was very surprised to see the results of these tests and am sure that there was an additional risk associated with my initial treatment recommendation,” said Tony Thomas, a heart disease patient. “My consultant was able to suggest a different approach after the test, and the outcome was excellent.”

Media angles and opportunities

• Patients who are interested in taking one of these tests can get in touch with the Devos Medical Group or one of their associated clinics. More information can be found at devos.com.
• Media outlets interested in getting further information about the testing and all the research involved can also reach out to the Devos Medical Group through the media contact listed below.
• Other medical outlets can also avail of this testing as part of a commercial arrangement with Devos and Futura Genetics. Contact the Devos sales office at sales@devos.com for more information.

Media assets

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Media contact

Issued for and on behalf of Devos Medical Group For media enquiries, kindly email Jane Doe, PR Manager at Zazoozoo, at jane.doe@zazoozoo.com or call +1 718 961 5461 during standard business hours.

About Devos Medical Group

Devos is a medical group that partners with doctors in specialized fields to finance and co-own clinics and health centres. We are dedicated to improving the health and well-being of individuals and families worldwide. Our mission is to provide high-quality, accessible healthcare to communities in need. We believe that by working closely with medical professionals and supporting them in the ownership and operation of their practices, we can deliver the best possible care to our patients. For more information, go to devos.com.