Latiglutenase for Celiac Disease

Overseen By Ana Ramos

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Entero Therapeutics

Disqualifiers: Wheat allergy, Type 1 diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test latiglutenase, a treatment for people with celiac disease who still have symptoms despite following a gluten-free diet. The study will compare latiglutenase to a placebo to determine its effectiveness in reducing symptoms. Participants should have a confirmed celiac diagnosis, follow a gluten-free diet for at least a year, and still experience moderate symptoms. Those who have adhered to a gluten-free diet but continue to feel unwell may find this trial suitable. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to potentially benefit from a new therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that latiglutenase is generally safe for people with celiac disease. In earlier studies, participants who took latiglutenase experienced no more side effects than those who took a placebo, a harmless pill. This suggests latiglutenase is likely safe for most individuals. Additionally, when taken with meals, it helps protect against accidental gluten exposure, a common concern for those with celiac disease. Overall, evidence suggests that latiglutenase is a safe and promising treatment for managing celiac disease symptoms. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for celiac disease?

Latiglutenase is unique because it offers a novel approach to managing celiac disease. Unlike standard treatments that require strict adherence to a gluten-free diet, latiglutenase works by breaking down gluten in the digestive system before it can trigger an immune response. This enzyme-based therapy could potentially alleviate symptoms and reduce intestinal damage for those who accidentally consume gluten. Researchers are excited about latiglutenase because it targets gluten directly, offering hope for improved quality of life for patients with celiac disease.

What evidence suggests that Latiglutenase might be an effective treatment for celiac disease?

Research has shown that latiglutenase, which participants in this trial may receive, can help protect the small intestine and reduce symptoms for people with celiac disease who accidentally consume gluten. Some studies found that it lessens intestinal damage and improves patient well-being. Latiglutenase breaks down gluten in the stomach, helping to prevent harm. However, not all studies agree on its benefits, with some finding no significant improvements. Overall, early evidence appears promising, but results have been mixed. Participants in this trial may also receive a placebo as part of the study's design. ^{1 2 3 4 5}

Who Is on the Research Team?

Joseph Murray, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Inclusion Criteria

You have had at least one symptom that you would describe as moderate or worse in the past 28 days.

Willing to take study treatment daily

Must sign informed consent

Exclusion Criteria

You have been told by a doctor that you have Type 1 Diabetes.

You are allergic to wheat.

You have a history of stomach ulcers, esophagus inflammation, irritable bowel syndrome, or inflammatory bowel disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment Period 1

Participants receive either Latiglutenase or placebo for the first 6-week period

6 weeks

Crossover

Participants switch to the alternate treatment (Latiglutenase or placebo) for another 6-week period

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Latiglutenase
• Placebo

How Is the Trial Designed?

Group I: Latiglutenase Active Control 1 Intervention

IMGX003

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Entero Therapeutics

Lead Sponsor

Trials

10

Recruited

410+

Immunogenics, LLC

Lead Sponsor

Trials

4

Recruited

220+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

In a phase 2 trial involving 41 adults with celiac disease, the glutenase ALV003 significantly protected against gluten-induced mucosal injury, as evidenced by stable villus height to crypt depth ratios and intraepithelial lymphocyte counts compared to the placebo group.

While ALV003 showed efficacy in preventing mucosal damage during a gluten challenge, there were no significant differences in patient symptoms between the ALV003 and placebo groups, indicating that while the treatment may protect the intestine, it does not necessarily alleviate symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glutenase ALV003 attenuates gluten-induced mucosal injury in patients with celiac disease. Lähdeaho, ML., Kaukinen, K., Laurila, K., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9707643/

Latiglutenase Protects the Mucosa and Attenuates ... Latiglutenase is given orally, protects the small intestine and reduces symptoms induced by gluten challenge without significant side effects in patients with ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1687197925000632

Efficacy of latiglutenase in treating celiac disease Some studies showed that, in patients with CeD, Latiglutenase reduced intestinal damage and improved symptom scores [11,12]. Conversely, other studies found no ...

3. gastrojournal.org gastrojournal.org/article/S0016-5085(22)00901-5/fulltext

Latiglutenase Protects the Mucosa and Attenuates ... Latiglutenase protects the mucosa and attenuates symptom severity in patients with celiac disease exposed to a gluten challenge.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35931103/

Latiglutenase Protects the Mucosa and Attenuates Symptom ... Latiglutenase Protects the Mucosa and Attenuates Symptom Severity in Patients With Celiac Disease Exposed to a Gluten Challenge.

5. celiac.org celiac.org/2021/05/06/significant-clinical-progress-for-latiglutenase/

Significant Clinical Progress for Latiglutenase Latiglutenase is a dual enzyme investigational product designed to break down gluten in the stomach. When taken with meals it offers celiac disease (CeD) ...