Currently, the only available treatment for coeliac disease is a strict lifelong gluten free diet. Managing a gluten free diet can be both challenging and costly. For many people, a gluten free diet is not entirely effective, with some people experiencing ongoing symptoms and intestines not completely healing. It can also bring significant social and emotional challenges, from anxiety around eating out and the risk of gluten exposure to feeling misunderstood or dismissed, impacting the overall quality of life. In a survey to Coeliac UK members in 2021, a new treatment to replace or support the gluten free diet was considered to be very or extremely important by 73.7% and 86.1% of participants, respectively. To hopefully reduce the burden of living with coeliac disease, researchers are working on developing future drug treatments.
Before a drug can be available for treatment, many stages of testing and approval processes must be carried out. Clinical trials are an important step, where investigational drugs are tested on human participants to ensure they are safe and effective.
Below, we take a closer look at three investigational treatments for coeliac disease that have recently reported positive clinical trial results, presented in no particular order.
TEV ‘408 – Teva Pharmaceuticals
Teva Pharmaceuticals is developing a potential new treatment for coeliac disease called TEV ‘408. The treatment blocks interluekin-15 (IL-15) which is a chemical messenger involved in the immune response (cytokine). In people with coeliac disease, IL-15 drives an inflammatory response triggered by gluten and helps activate immune cells to attack the tissue in the intestines. By blocking IL-15, TEV ‘408 aims to reduce intestinal damage and symptoms.
Teva has recently announced positive topline results from a Phase 2a trial, involving 50 participants with coeliac disease on a gluten free diet. Participants received either a single dose of TEV ‘408 or a placebo, an inactive replica of the treatment containing no active drug, via injection. Both groups then underwent a 6 week gluten challenge under medical supervision, during which they consumed gluten so researchers could assess how well TEV ‘408 blocked the immune response in the presence of gluten compared with the placebo.
The trial showed success, with participants who received TEV ‘408 having significantly less gluten induced damage to the intestines and inflammation than those in the placebo group. They also reported less symptoms. Additionally, Teva has shared that the drug has been well-tolerated, with no emerging safety issues.
Teva is continuing to analyse the results before they progress to the next development stage.
FB102 – argenx
argenx is in the process of developing FB102 as a potential coeliac disease treatment. FB102 is a liquid delivered directly into veins, designed to inhibit IL-15 and another signalling molecule called interleukin 2 (IL-2) involved in inflammation in coeliac disease. IL-2 has also been closely linked to symptom development. The drug is designed to bind to the receptor CD122 on immune cells, blocking IL-15 and IL-2 from binding and therefore stopping their inflammatory signals and inappropriate activation of immune cells. FB102 intends to interrupt the immune system’s response to gluten in coeliac disease, before it can cause damage to the small intestine.
In a Phase 2 study, FB102 was evaluated in 126 adults with coeliac disease who were symptom free on a strict gluten free diet for at least 12 months. Participants were randomly assigned to receive FB102 or a placebo, while undergoing an 8 week gluten challenge.
argenx has announced that FB102 demonstrates better protection against gluten compared to the placebo. Participants receiving FB102 had less damage to the lining of the gut and had a smaller inflammatory immune response to gluten. There were also no safety related concerns reported.
argenx plans to advance FB102 into later stage developments to assess its function in a larger group of people.
ANB033 – First Tracks Biotherapeutics
Another potential therapy under investigation is ANB033, developed by First Tracks Biotherapeutics (recent spin out from AnaptysBio). Similar to FB102, it is designed to block the CD122 receptor involved in the signalling pathways of IL-15 and IL-2, which play a role in the immune response in coeliac disease.
In a Phase 1b trial, ANB033 is being assessed across two cohorts. Cohort 1 involved 32 people with coeliac disease undertaking a 14 day gluten challenge, followed by a 6 week follow up to assess the safety and how effective the drug was at preventing gluten induced intestinal damage and symptoms. Cohort 2 will then assess how the small intestine heals and how symptoms improve in the absence of a gluten challenge.
Earlier in October, positive results from Cohort 1 were shared by First Tracks Biotherapeutics, with findings indicating that:
- Participants receiving ANB033 had significant protection against intestinal damage
- Participants receiving ANB033 reported fewer symptoms overall and were protected from an increase in symptoms during the gluten challenge
- Only 6% of participants receiving ANB033 sought medications to cope with symptoms, compared with 47% of participants receiving a placebo
- ANB033 was well tolerated and had no emerging safety issues
The trial’s second cohort is currently underway, with results expected in early 2027, and plans for further research for the end of 2027.
What does this mean for people with coeliac disease?
The recent positive clinical trial results around these 3 investigational treatments are an interesting step towards new treatment options that could one day complement or even change the way coeliac disease is managed. Coeliac UK will continue to follow developments in this space and share updates with the community.
However, it is important to note that these therapies are not currently approved treatments for coeliac disease. Further research is needed to establish their safety and effectiveness, and it is not yet certain whether they will ultimately become available to patients.
Interested in reading more?
- Teva Pharmaceuticals: here
- argenx: here
- First Tracks Biotherapeutics: here