KAN-101 for Celiac Disease

No longer recruiting at 37 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

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, an autoimmune condition where gluten consumption damages the small intestine. The trial aims to observe the body's response to different doses of KAN-101 and assess its safety and tolerability. Participants will be divided into groups, with some receiving varying doses of KAN-101 and others receiving a placebo (a substance with no active treatment). Suitable candidates for this trial have been diagnosed with celiac disease, follow a gluten-free diet, and possess specific genetic markers. As a Phase 1, Phase 2 trial, this research focuses on understanding how KAN-101 works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking treatment development.

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 KAN-101 is safe. In earlier studies, people with celiac disease tolerated KAN-101 well. No severe side effects halted the increase in dosage. Additionally, researchers did not identify a dose that was too high to tolerate, indicating that the treatment remains safe even at higher doses. Overall, these findings suggest that KAN-101 is safe for people with celiac disease. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

KAN-101 is unique because it offers a new approach to treating celiac disease, a condition traditionally managed with a strict gluten-free diet. Unlike most treatments that rely on dietary changes, KAN-101 is administered through intravenous infusions, which means it's delivered directly into the bloodstream. This treatment is exciting because it targets the immune system in a novel way, potentially reprogramming it to tolerate gluten without triggering harmful reactions. Researchers are hopeful this could provide relief and improve quality of life for those with celiac disease who struggle with dietary management.

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

Research has shown that KAN-101 could be a promising treatment for celiac disease. In this trial, participants will receive varying doses of KAN-101 or a placebo. Previous studies found that KAN-101 reduced several gluten-related symptoms common in celiac disease. The treatment also improved health measures specific to the condition, suggesting it might help manage it more effectively. Importantly, reports indicate that KAN-101 is safe, as it did not cause severe side effects in patients. Overall, these findings suggest that KAN-101 could ease living with celiac disease. ^{1 2 3 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 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. 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?term=kan-101&rank=2

A Study of Efficacy, Safety, and Tolerability of KAN-101 in ... Previous diagnosis of celiac disease based on histology and positive celiac serology; HLA-DQ2.5 genotype; Gluten-free diet for at least 12 months; Negative or ...

4. 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 and celiac-specific composite measures in a Phase 2 trial.

5. 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.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05574010

NCT05574010 | A Study of Safety, Tolerability, ... This study is to evaluate the Pharmacodynamic (PD), safety, tolerability, Pharmacokinetic (PK), and plasma biomarker response of KAN-101 in participants with ...