Celiac disease, a chronic autoimmune disorder affecting millions of Americans, currently has no treatment beyond a strict gluten-free diet. However, recent advancements in research and clinical trials offer hope for patients suffering from the disease, with several companies developing innovative therapies.
Celiac disease damages the small intestine and impairs nutrient absorption in response to gluten. For the 3 million Americans living with the condition, flare-ups can lead to severe complications like lymphoma, osteoporosis, anemia, and malnutrition, even from small traces of gluten. A gluten-free diet remains the only effective way to manage the disease, but this comes with challenges as accidental gluten exposure is common and difficult to avoid entirely.
As a result, pharmaceutical companies are increasingly focused on developing new treatments to address celiac disease more directly. If approved, these therapies could eliminate the need for complete gluten avoidance, offering a profound shift in how the condition is managed.
Promising Enzyme Therapy from Entero Therapeutics
Entero Therapeutics is leading the charge with its investigational treatment, latiglutenase, a gluten-specific enzyme designed to break down gluten in the stomach. Known as IMGX003, latiglutenase is an orally administered combination of two recombinant proteases that degrade gluten into smaller, less harmful pieces. Entero’s Phase III trials are set to begin in early 2025.
Results from a Phase II trial in 2022 demonstrated that latiglutenase significantly reduced gluten-induced damage to the small intestine compared to a placebo. This study, which used villus height to crypt depth ratio as the primary endpoint, showed that latiglutenase could effectively mitigate the mucosal damage typically caused by gluten exposure.
Anokion’s Immunotherapy Approach
Anokion is another company making significant strides in celiac disease treatment. The company’s KAN-101, a synthetic gluten antigen delivered to immune cells in the liver, is currently undergoing Phase II trials in its SynCeD study. KAN-101 works by modifying the immune response to gluten to prevent flare-ups.
Anokion’s previous Phase I trial, ACeD, provided promising data showing that KAN-101 was safe and well-tolerated. Patients demonstrated functional tolerance to gluten exposure, suggesting that the treatment could help those with celiac disease gradually reintroduce gluten into their diets without triggering adverse effects.
Sanofi’s Monoclonal Antibody Therapy
Sanofi is also exploring a treatment for celiac disease through amlitelimab, a monoclonal antibody targeting OX40L, a ligand found on immune cells. By binding to OX40L, amlitelimab limits immune cell activation and inflammation. The Phase II trials aim to evaluate the treatment’s efficacy in patients with celiac disease who have not responded to other therapies.
Amlitelimab is being tested in various conditions beyond celiac disease, including atopic dermatitis, asthma, and systemic sclerosis, showcasing its versatility as a potential immune-modulating therapy.
Takeda’s Comprehensive Treatment Strategy
Takeda Pharmaceuticals is taking a multifaceted approach to celiac disease, with three investigational treatments in development. TAK-101 is an immune-modifying nanoparticle designed to help the body tolerate gluten. Zamaglutenase (TAK-062), an oral glutenase enzyme, and TAK-227 (ZED-1227), a transglutaminase 2 inhibitor, offer additional options for addressing the disease through immune modulation and inhibition of gluten-induced damage.
Takeda is currently enrolling patients for Phase II trials of TAK-101, while its Phase II trials for zamaglutenase were completed in late 2024. Data from earlier trials of TAK-227 demonstrated its ability to reduce duodenal mucosal damage caused by gluten, providing additional evidence of its potential efficacy.
A Bright Future for Celiac Disease Treatments
While setbacks have occurred in recent years with treatments like larazotide and AMG 714 failing to reach approval, the future of celiac disease treatment remains promising. With a number of therapies in late-stage trials, patients may soon have more options for managing their condition. As clinical trials continue to progress, it is anticipated that new treatments could be available within the next three to five years, bringing new hope to those living with celiac disease.
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