KAN-101 for Celiac Disease

(SynCeD Trial)

No longer recruiting at 34 trial locations

Overseen By Jeff Conlon

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA

Disqualifiers: Refractory celiac, HLA-DQ8, IgA deficiency, Type-I diabetes, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called KAN-101 for individuals with celiac disease. Researchers aim to determine if KAN-101 is safe and effective in managing this condition. Participants will receive either KAN-101 or a placebo (a substance with no active medicine) through three IV infusions. Ideal candidates for this trial have celiac disease, have followed a gluten-free diet for at least a year, and meet specific genetic and blood test criteria. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

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 KAN-101 is likely to be safe for humans?

Research shows that KAN-101 is generally safe for people with celiac disease. Studies have found that patients tolerate it well, meaning most can take it without problems. Importantly, no severe side effects prevented participants from taking a higher dose. Researchers did not find a dose too high to be safe, suggesting that even larger amounts could be acceptable. Overall, previous research found KAN-101 to be safe and well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Celiac Disease?

KAN-101 is unique because it offers a novel approach to treating celiac disease by potentially reprogramming the immune system to tolerate gluten. Unlike the standard of care, which mainly involves a strict gluten-free diet and doesn't address the underlying immune response, KAN-101 targets the immune cells that mistakenly attack gluten. Researchers are excited about this treatment because it could provide a more effective, long-term solution for celiac disease, improving the quality of life for those who struggle with dietary restrictions.

What evidence suggests that KAN-101 might be an effective treatment for Celiac Disease?

Research shows that KAN-101, which participants in this trial may receive, could be a promising treatment for celiac disease. In earlier studies, KAN-101 showed potential to change how the disease develops. It targets the immune system in the liver to help reduce the body's reaction to gluten. Importantly, early data suggests it is safe, with no serious side effects or dosage limits identified. This means it could help manage symptoms and possibly alter the course of the disease. ^{1 2 4 5 6}

Who Is on the Research Team?

Study Director

Principal Investigator

Anokion SA

Are You a Good Fit for This Trial?

This trial is for people with Celiac Disease who have been on a gluten-free diet for at least a year. They should have certain genetic markers (HLA-DQ2.5), a previous diagnosis confirmed by tests, and specific biopsy results showing intestinal damage.

Inclusion Criteria

I have been diagnosed with celiac disease confirmed by tests and biopsy.

You have been on a gluten-free diet for at least 12 months.

Intestinal biopsy screening reveals a Vh:Cd ratio of at least 2.3.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 intravenous (IV) infusions of KAN-101 or placebo

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KAN-101

Trial Overview The study is testing KAN-101 against a placebo to see if it's effective, safe, and tolerable for those with Celiac Disease. Participants will randomly receive either the actual drug or an inactive substance to compare outcomes.

How Is the Trial Designed?

Group I: Group 1 Experimental Treatment 1 Intervention

All eligible participants will receive 3 intravenous (IV) infusions of KAN-101

Group II: Group 2 Placebo Group 1 Intervention

All eligible participants will receive 3 intravenous (IV) infusions of placebo

Who Is Running the Clinical Trial?

Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA

Lead Sponsor

Trials

3

Recruited

220+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. celiac.org celiac.org/2024/05/22/anokion-announces-new-clinical-data-from-aced-it-trial-supporting-kan-101-as-a-potential-disease-modifying-treatment-for-celiac-disease/

Anokion Announces New Clinical Data from ACeD-it Trial ... Anokion announces new clinical data from the Phase 1b/2 ACeD-it trial supporting KAN-101 as a potential disease-modifying treatment for celiac disease.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37329900/

Safety and tolerability of KAN-101, a liver-targeted immune ... KAN-101 has an acceptable safety profile in patients with coeliac disease with no dose-limiting toxicities and no maximum tolerated dose was observed.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06001177

NCT06001177 | A Study of Efficacy, Safety, and Tolerability ... The study goal is to evaluate the efficacy, safety, and tolerability of KAN-101 in participants with Celiac Disease (CeD)

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468125323001073

Safety and tolerability of KAN-101, a liver-targeted immune ... KAN-101 has an acceptable safety profile in patients with coeliac disease with no dose-limiting toxicities and no maximum tolerated dose was observed.

5. anokion.com anokion.com/pipeline/assessment-of-kan-101-in-celiac-disease/

ACeD | Celiac Disease KAN-101 is an investigational treatment for Celiac Disease (CeD). It encompasses a well-described gluten antigen that is implicated in driving the onset of ...

6. anokion.com anokion.com/press_releases/anokion-announces-positive-symptom-data-from-its-phase-2-trial-evaluating-kan-101-for-the-treatment-of-celiac-disease/

Anokion Announces Positive Symptom Data from its Phase ... The data indicate KAN-101 reduces multiple gluten induced symptoms ... KAN-101 was safe and tolerated in individuals with celiac disease.