KAN-101 for Celiac Disease

Recruiting at 35 trial locations

Overseen By Kanyos Bio, Inc. (a wholly owned subsidiary of Anokion S.A.)

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

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

Disqualifiers: Refractory celiac, Type-1 diabetes, others

Compensation: Varies

Number of Visits: 6

126 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests KAN-101, a new drug for adults with Celiac Disease on a gluten-free diet. Researchers are studying its safety, tolerance, and effects on the body and blood markers after gluten exposure.

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.

How is the drug KAN-101 different from other treatments for celiac disease?

KAN-101 is unique because it is designed to target the liver and induce immune tolerance to gliadin, a component of gluten, which is different from the standard gluten-free diet that only avoids gluten without modifying the immune response. ^{1 2 3 4 5}

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 a specific genetic marker (HLA-DQ2.5), are on a gluten-free diet for at least one year, and have certain levels of celiac disease antibodies. It's not open to those with other active gut diseases, skin conditions related to celiac disease, Type-1 diabetes, or those who've had a gluten challenge recently.

Inclusion Criteria

You have been eating a diet that doesn't contain gluten for at least 12 months.

Your blood test shows negative or slightly positive results for certain antibodies related to gluten sensitivity.

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

Exclusion Criteria

I have been diagnosed with Type-1 diabetes.

I have an active stomach or intestine disease.

I have the HLA-DQ8 genotype.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment Part A

Open-label, multiple ascending dose study to assess safety, tolerability, and PK of KAN-101

7 days

3 visits (in-person)

Follow-up Part A

Participants are monitored for safety and effectiveness after treatment in Part A

21 days

Treatment Part B and C

Double-blind, placebo-controlled study to assess biomarker response, safety, tolerability, and PK of KAN-101

28 days

3 visits (in-person)

Follow-up Part B and C

Participants are monitored for safety and effectiveness after treatment in Part B and C

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KAN-101
• Placebo

Trial Overview The study tests KAN-101's effects in Celiac Disease patients. Participants will receive different doses of KAN-101 or placebo to assess the drug’s safety, how it affects the body (pharmacodynamics), how the body processes it (pharmacokinetics), and its impact on blood markers.

How Is the Trial Designed?

Group I: Group 4 in Part B and Part C Experimental Treatment 1 Intervention

All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 5

Group II: Group 3 in Part B and Part C Experimental Treatment 1 Intervention

All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 4

Group III: Group 2 in Part B and Part C Experimental Treatment 1 Intervention

All eligible Part B and Part C participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 3

Group IV: Cohort 2 in Part A Experimental Treatment 1 Intervention

All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 2

Group V: Cohort 1 in Part A Experimental Treatment 1 Intervention

All eligible Part A participants will receive 3 intravenous (IV) infusions of KAN-101 Dose 1

Group VI: Group 1 in Part B and Part C Placebo Group 1 Intervention

All eligible Part B and Part C 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

Published Research Related to This Trial

KAN-101, a new treatment for coeliac disease, demonstrated an acceptable safety profile in a phase 1 study with 41 participants, showing no serious adverse events or dose-limiting toxicities.

The drug was rapidly cleared from the body, with a half-life of about 3.72 to 31.72 minutes, indicating it does not accumulate with repeated dosing, which is important for its potential use in managing coeliac disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of KAN-101, a liver-targeted immune tolerance therapy, in patients with coeliac disease (ACeD): a phase 1 trial. Murray, JA., Wassaf, D., Dunn, K., et al.[2023]

In a study of 20 celiac disease patients, the use of Native-complex Fucus jelly over 2 months significantly improved stool consistency and frequency, with 70% of patients achieving daily bowel movements by the end of the study.

The functional food also positively impacted gut microbiota, correcting dysbiosis and enhancing intestinal health, which is often compromised in patients following a long-term gluten-free diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FUNCTIONAL FOODS ARE CRITICAL COMPONENTS OF TREATMENT OF METABOLIC DISORDERS IN CELIAC DISEASE. Tkachenko, EI., Oreshko, LS., Sitkin, SI., et al.[2018]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and tolerability of KAN-101, a liver-targeted immune tolerance therapy, in patients with coeliac disease (ACeD): a phase 1 trial. [2023]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

FUNCTIONAL FOODS ARE CRITICAL COMPONENTS OF TREATMENT OF METABOLIC DISORDERS IN CELIAC DISEASE. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The role of animal models in unravelling therapeutic targets in coeliac disease. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

A 10-residue peptide from durum wheat promotes a shift from a Th1-type response toward a Th2-type response in celiac disease. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Oral Consumption of Bread from an RNAi Wheat Line with Strongly Silenced Gliadins Elicits No Immunogenic Response in a Pilot Study with Celiac Disease Patients. [2022]