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Celiac.com 09/09/2019 - A new oral drug for treating celiac disease could allow people with the disease to safely consume wheat, eliminating the need for a gluten-free diet. Capsules of ActoBiotics AG017 from ActoBio Therapeutics were recently granted new investigational drug (IND) status by the US Food and Drug Administration (FDA). The drug contains a customized version of the bacterium Lacotococcus lactic, designed to express a gliadin peptide, coupled with an immunomodulating cytokine. The drug can be administered orally or topically, and so requires no injections. According to the company, ActoBiotics therapies promote antigen-specific immune tolerance that can prevent or reverse certain autoimmune and allergic diseases. AG017 is an antigen-specific celiac therapy with the potential to reverse gluten sensitivity that is aimed at the over 90% of celiac patients with the HLA-DQ2.5 genotype that responds to its immunomodulating cytokine. The drug will begin a Phase Ib/IIa study in patients with celiac disease in the US and Europe later in 2019. What do you think? Promising? Or likely more hype? Over the years, the celiac disease community has heard much about the promise of new drugs and treatments touting their ability to eliminate the need for a gluten-free diet, but nothing has come of it. We'll be keeping an eye on this drug to see how it pans out, so stay tuned.
Celiac.com 11/13/2017 - ImmusanT, Inc., the company working to develop a therapeutic vaccine to protect HLADQ2.5+ patients with celiac disease against the effects of gluten, presented data that shows a way to tell the difference between celiac disease and non-celiac gluten-sensitive (NCGS) based on cytokine levels. Professor Knut Lundin, University of Oslo, presented the data at United European Gastroenterology (UEG) Week 2017. The results are important, in part because many people go on a gluten-free diet before they ever get diagnosed with celiac disease. It's hard for doctors to ask these people to start eating gluten again so that they can be properly diagnosed. But that's how it currently works. If there are no anti-gliadin antibodies in your blood, current tests are not accurate. These data suggest that it is possible to spot celiac disease through plasma or blood test. Along with easier, more accurate celiac diagnoses, a blood test would be a major breakthrough because "patients would only be required to consume gluten on one occasion and would still achieve accurate results," said Robert Anderson, MBChB, Ph.D., Chief Scientific Officer of ImmusanT. The test may also help people who do not have celiac disease, but find symptom relief on a gluten-free diet. For these people, gluten may not be the cause of their symptoms and a gluten-free diet may be totally unnecessary. The latest data support the company's approach to "developing a simple blood test for diagnosing celiac disease without the discomfort and inconvenience of current testing methods. This would be the first biomarker for measuring systemic T-cell immunity to gluten," said Leslie Williams, Chief Executive Officer of ImmusanT. As development is ongoing, further tests are expected to flesh out the details. Source: Immusant
Celiac.com 12/07/2016 - Refractory celiac disease (RCD) is a form of celiac disease that does not respond to treatment with gluten-free diet, and often involves greater risk of complications. The guts of many RCD patients over-produce effector cytokines, which are supposed to amplify the tissue-destructive immune response. However, it remains unclear if the RCD-associated mucosal inflammation is sustained by defects in counter-regulatory mechanisms. A team of researchers recently set out to determine whether RCD-related inflammation is marked by high Smad7, an intracellular inhibitor of transforming growth factor (TGF)-β1 activity. The research team included S Sedda, V De Simone, I Marafini, G Bevivino, R Izzo, OA Paoluzi, A Colantoni, A Ortenzi, P Giuffrida, GR Corazza, A Vanoli, A Di Sabatino, F Pallone, and G Monteleone. They are variously affiliated with the Department of Systems Medicine at the University of Rome "Tor Vergata," the First Department of Internal Medicine at the Fondazione IRCCS Policlinico San Matteo of the University of Pavia, and with the Department of Molecular Medicine at San Matteo Hospital at the University of Pavia in Pavia, Italy. The team evaluated Smad7 in duodenal biopsy samples of patients with RCD, patients with active celiac, patients with inactive celiac disease and healthy controls by Western blotting, immunohistochemistry and real time-PCR. In the same samples, they used ELISA and immunohistochemistry to assess TGF-β1 and phosphorylated (p)-Smad2/3, respectively. They evaluated pro-inflammatory cytokine expression in RCD samples cultured with Smad7 sense or antisense oligonucleotide. Smad7 protein, but not RNA, expression was increased in RCD, as compared to active and inactive celiac patients and healthy controls. This increased expression was associated with defective TGF-β1 signaling, as marked by diminished p-Smad2/3 expression. TGF-β1 protein content did not differ among groups. Knockdown of Smad7 in RCD biopsy samples reduced IL-6 and TNFα expression. These results show that, in RCD, high Smad7 associates with defective TGF-β1 signaling, and sustains inflammatory cytokine production. These results suggest a novel mechanism by which amplifies mucosal cytokine response in RCD, and suggest that treatments targeting Smad7 might be helpful in RCD. Source: Immunology. 2016 Nov 14. doi: 10.1111/imm.12690.