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Celiac disease treatments in development - Overview - June 2023

Coeliakie behandelingen in ontwikkeling - Overzicht - Juni 2023

Although a cure for celiac disease is currently impossible, there are exciting developments underway in the medical and scientific world that could lead to new and improved treatments. At Little Helpers we follow these developments closely and every month we provide you with an up-to-date overview of all future treatments, including therapies that are still in the experimental phase.

From designing drugs that can calm the immune system to developing vaccines that can stimulate a tolerance to gluten, we summarize the latest updates for you in this handy overview:

Pre-clinical phase (in vitro & in vivo)

Laboratory tests and animal studies to assess the safety of a drug or other treatment and to investigate its therapeutic potential.

AMYRA Biotech AG, AMY02

AMYRA, a biotechnology company, is currently working on a promising new enzyme-based therapy for celiac disease, aimed at neutralizing the negative effect of gluten. Read more about AMYRA Biotech AG.

Circle33/Avaxia Biologics, AVX-176

Avaxia is primarily focused on research into inflammatory diseases that affect the digestive system. They have identified potential targets for antibodies that could have beneficial effects on celiac disease.Read more about Avaxia Biologics .

ExPharma/Nemysis, E40-02

ExPharma Limited, a medical food development company, acquired Nemysis Limited. In May 2021, Nemysis was granted a Canadian patent for E40, a potential first-line treatment against gluten toxicity in patients with celiac disease and people with gluten sensitivity. Read more about ExPharma and Nemysis .

Mozart Therapeutics, CD8 Treg Cell Modulators

Mozart Therapeutics is working on CD8 T regulatory cell modulators as a potential treatment for celiac disease and other autoimmune diseases. In May 2022, Mozart researchers presented preclinical results demonstrating the potential of these targeted modulators to reduce the autoimmune inflammatory response by removing harmful immune cells. Read more about Mozart Therapeutics.

Precigen ActoBio, Actobiotics® AG017

Precigen ActoBio is an innovative clinical-stage biotechnology company focused on a new class of microbe-based therapeutics. Precigen ActoBio's AG017 (ActoBiotics®) is a candidate for antigen-specific immunotherapy based on the safe, food-grade bacterium, Lactococcus lactis. This is specifically designed to express a gliadin peptide (a component of gluten) in combination with a cytokine (a protein that modifies the immune system). This experimental therapy has the potential to reverse gluten intolerance. Precigen ActoBio hopes to test AG017 for safety and efficacy in patients with celiac disease. Read more about Precigen ActoBio.

Provide Pharmaceuticals

Provid focuses on synthetic and medicinal chemistry and is developing inhibitors for DQ2 and DQ8, the two genes associated with celiac disease. Read more about Provid Pharmaceuticals.

Selecta Biosciences, SVP

Selecta's celiac disease program aims to induce immune tolerance by using their proprietary Synthetic Vaccine Particle (SVP™) platform to develop an immunotherapy for the treatment of celiac disease. Read more about Selecta Biosciences.

Phase 1 (20 - 100 participants)

Initial human trials, usually in a small number of healthy volunteers, to evaluate the safety and dosage of a drug.

Anokion, KAN-101

Anokion SA and its subsidiary Kanyos Bio, Inc. have developed KAN-101, an experimental treatment that targets the immune cells that cause celiac disease while leaving the otherwise healthy components of the immune system intact. KAN-101 works by re-educating, or tolerating, T cells so that they do not respond to gluten antigens. The Celiac Disease Foundation is now recruiting for the KAN-101-02 Study, a phase 1b/2 clinical trial to evaluate the safety and tolerability of KAN-101 in people with celiac disease. See if you qualify.

Australian Institute of Tropical Health & Medicine (AITHM) at James Cook University, Hookworm Larvae

AITHM hopes to find a drug derived from hookworm larvae to treat gluten sensitivity. Hookworms can secrete anti-inflammatory proteins, which can be put into a pill and ultimately restore gluten tolerance. The most recently completed Phase 1b trial involved applying hookworm larvae to participants' skin, where it was found that participants treated with hookworms tended to have an improved tolerance to low levels of gluten consumption. AITHM researchers are still examining the biological samples they collected in this study and continuing their efforts to advance worm molecules as therapeutics. Read more about AITHM.

Calypso Biotech, CALY-002

Calypso Biotech is a biopharmaceutical company developing CALY-002, an antibody that inhibits the cytokine, Interleukin-15 (IL-15), which plays multiple roles in the immune system, especially in the gastrointestinal tract. CALY-002 has the potential to treat several gastrointestinal conditions that currently have no approved treatment, including celiac disease. Calypso is currently conducting a Phase 1b clinical trial to test the safety and tolerability of CALY-002 in healthy volunteers and volunteers with celiac disease. Read more about Calypso.

Chugai Pharmaceutical Co., DONQ52

Chugai is conducting a Phase 1 clinical trial for DONQ52, an experimental drug designed to target an immune complex known to cause celiac disease symptoms. DONQ52 is also expected to protect the small intestine from damage caused by gluten exposure. The Celiac Disease Foundation is currently recruiting for Chugai's LILY Study, which is evaluating the safety and tolerability of single or multiple doses of DONQ52 in patients with celiac disease. See if you qualify.

Equillium, EQ102

Equillium, a clinical biotechnology company that acquired Bioniz Therapeutics in February 2022, is conducting a Phase 1 study to evaluate the safety and tolerability of EQ102. EQ102 is a first-of-its-kind, bi-specific cytokine inhibitor and is part of Equillium's proprietary Multi-Cytokine Platform. EQ102 may be an optimal approach for the treatment of patients with celiac disease because it inhibits the natural biological synergy of cytokines IL-15 and IL-21, which drive cytotoxic T cell responses in gastrointestinal inflammation. Read more about Equillium.

Immunic Therapeutics, IMU-856

Immunic is a clinical biotechnology company developing treatment options for chronic inflammatory and autoimmune diseases, including IMU-856, a small molecule modulator that targets a protein involved in the regulation of intestinal barrier function and regeneration of the intestinal epithelium. The drug aims to restore intestinal barrier function and intestinal wall architecture without compromising immune function in patients suffering from gastrointestinal diseases such as celiac disease. In May 2023, Immunic announced positive results from its Phase 1b clinical trial in patients with celiac disease. IMU-856 was found to be safe and well tolerated in this trial and showed positive results in four key dimensions of the pathophysiology of the disease: histology, disease symptoms, biomarkers and nutritional intake. Immunic is currently preparing for a Phase 2b clinical trial in patients with celiac disease. Read more about Immunic.

National Cancer Institute, Mayo Clinic, University of Chicago Medicine, Hu-Mik-Beta-1

Hu-Mik-Beta-1 is a monoclonal antibody that targets the cytokine receptor subunit IL-2/IL-15Rβ (CD122) and also blocks IL-15 transpresentation. The antibody is being tested for the treatment of refractory celiac disease. Read more about Hu-Mik-Beta-1.

Nielsen Fernandez-Becker (Stanford University) and Protagonist Therapeutics, PTG-100

Nielsen Fernandez-Becker, head of the Celiac Disease Program at Stanford University, is working with Protagonist Therapeutics to test the safety and effectiveness of the drug PTG-100 in patients with celiac disease. PTG-100 is an oral peptide that blocks the function of alpha-4-beta-7 integrin, a cell receptor involved in the gastrointestinal inflammatory response. The goal of this Phase 1b study is to learn whether PTG-100 can reduce or prevent the inflammatory injury to the small intestine that occurs when people with celiac disease eat food products containing gluten. Read more about Nielsen Fernandez-Becker.

Phase 2 (100 - 300 participants)

Phase 2: Testing the drug in a larger group of patients to further assess effectiveness and side effects.

Amgen and Provention Bio, PRV-015 (formerly AMG 714)

Provention Bio licensed PRV-015 from Amgen in 2018. PRV-015 is an antibody that targets IL-15, a cytokine that is one of the key factors in the loss of tolerance to food antigens and reportedly involved in celiac disease, refractory celiac disease (RCD), and other autoimmune disorders. See if you qualify for the phase B study.

IGY Life Sciences, Vetanda Group Ltd., and The University of Alberta, AGY-010

Researchers from the University of Alberta and IGY have developed an oral egg antigliadin antibody (AGY), a new treatment intended to neutralize hidden gliadin in food. To help chicks fight disease, mother hens produce natural antibodies known as yolk immunoglobulin. In collaboration with IGY, researchers from the University of Alberta have developed egg yolk antibodies that target wheat proteins. Anti-gluten immunoglobulin yolk antibodies bind to problematic wheat proteins, rendering them harmless to people with celiac disease. A phase 2 trial is currently underway to test the safety and efficacy of an orally administered capsule containing egg yolk and AGY in patients with celiac disease. Read more about Vetanda.

ImmunogenX, IMGX003 (Latiglutenase)

ImmunogenX is developing latiglutenase (IMGX003; formerly ALV003, Alvine Pharmaceuticals), a mixture of two gluten-specific enzymes that break down gluten proteins into small, harmless fragments. It is intended to be administered in addition to a gluten-free diet for the possible treatment of celiac disease. The technology has been extensively studied in Phase 1 and Phase 2 clinical trials, and has been shown to reduce gluten-induced intestinal mucosal injury, as well as improve symptoms in clinical trials. ImmunogenX is currently conducting an NIH-funded Phase 2 study evaluating the beverage-based study drug latiglutenase and its ability to relieve common symptoms in patients with celiac disease after accidental gluten exposure. Read more about ImmunogenX.

Oslo University Hospital, Teriflunomide

Researchers at Oslo University Hospital are currently testing the effects of teriflunomide in patients with celiac disease. Teriflunomide is an immunomodulatory agent, administered orally, already used to treat multiple sclerosis. This phase 2a proof-of-concept study will test the drug's effects on the activation and efflux of gluten-specific T cells using HLA-DQ:gluten tetramers. The aim of this study is to see whether teriflunomide can inhibit immune activation in patients with celiac disease during a 3-day gluten challenge. Read more about celiac disease research at the University of Oslo.

Takeda Pharmaceuticals, TAK-062

Following a successful Phase 1 proof-of-mechanism study, Takeda has acquired PvP Biologics and is continuing development of TAK-062 (also known as Kuma062, formerly KumaMax). TAK-062 is a very powerful enzyme designed to recognize and break down the parts of gluten that trigger the immune response before those parts leave the stomach and reach the small intestine. See if you are eligible to participate in the study.

Takeda Pharmaceuticals and Cour Pharmaceuticals, TAK-101

Takeda licensed TAK-101 (formerly CNP-101 or TIMP-GLIA) from Cour Pharmaceuticals in 2019. With TAK-101, the body's immune system is reprogrammed to tolerate gluten as a non-threatening substance and then reverse the signs and symptoms of celiac disease without the use of immunosuppressive medications. By encapsulating a component of wheat in a small particle, Cour has developed a "backdoor" approach in which the gluten is not recognized by the body's immune system until it reaches the spleen, where immune tolerance can be generated. Takeda plans to initiate a Phase 2 dose-ranging study to further explore the potential of TAK-101 in treating patients with celiac disease on a gluten-free diet. Read more about Takeda.

Takeda, Dr. Falk Pharma, and Zedira, TAK-227/ZED1227

TAK-227 (ZED1227) is a selective, oral small molecule designed to inhibit tissue transglutaminase (TG2) to prevent mucosal damage in the small intestine by preventing the body's immune response to gluten. A phase 2a proof-of-concept gluten challenge study showed that TAK-227 successfully reduced gluten-induced duodenal mucosal damage in people with celiac disease. In October 2022, Takeda announced a collaboration and licensing agreement to continue development of Phase 2b of TAK-227 in collaboration with Zedira and Dr. Falk Pharma. Read more about Takeda.

Topas Therapeutics, TPM502

Topas Therapeutics is a clinical-stage biotechnology company with a mission to deliver novel, disease-modifying treatments for autoimmune and inflammatory diseases. Topas is developing antigen-specific proprietary nanoparticles, called TPCs (Topas Particle Conjugates), that leverage the liver's natural mechanisms to promote antigen-specific immune tolerance without broadly suppressing the immune response. Topas is currently conducting a Phase 2a clinical trial to test TPM502 for the treatment of celiac disease. Read more about Topas.

Phase 3 (1,000 - 2,000 participants)

Large studies in patients to confirm the drug's effectiveness, monitor side effects, and compare it with existing treatments or a placebo.

There are currently no Phase 3 studies underway.

Phase 4 (post-marketing)

Post-market research to study the long-term effects of a medicine and to discover possible new applications.

There are currently no Phase 4 studies underway.

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What is Tolerase® G?

What is Tolerase® G?

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