During the drug development process, multiple studies are performed to evaluate efficacy, safety, tolerability, pharmacokinetics, and other factors. One of these studies is called a multiple ascending dose study, during which patients receive multiple doses and the dose increases for each cohort. On March 16, 2021, Swiss biotechnology company Anokion SA (“Anokion”) shared that it had initiated its multiple ascending dose portion of the Phase 1 ACeD clinical trial. During the trial, researchers will evaluate KAN-101 for patients with celiac disease.
KAN-101
Developed by Anokion, KAN-101 is an investigational treatment designed to “re-educate” immune cells. In this case, celiac disease causes immune cells to attack gluten antigens. KAN-101 works to prevent this from occurring, allowing patients to eat gluten without the negative side effects. Currently, the drug is being evaluated in a Phase 1 ACeD clinical trial. During the multiple ascending dose portion, 40 patients will enroll. Patients must be on a gluten-free diet. In the first portion of the trial, four single-ascending dose cohorts will receive one KAN-101 administration. In the second part, patients in three multiple-ascending dose cohorts will receive either a placebo or 3 doses of KAN-101.
Throughout the trial, researchers hope to understand the safety, serum concentrations, pharmacokinetics, and tolerability of KAN-101.
Celiac Disease
According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Celiac disease is a chronic digestive and immune disorder that damages the small intestine. The disease is triggered by eating foods containing gluten [and] can cause long-lasting digestive problems and keep your body from getting all the nutrients it needs.
An estimated 1 in every 100 people worldwide have celiac disease, which may also be referred to as gluten intolerance. This condition occurs in people who are genetically predisposed. As the Celiac Disease Foundation explains:
When people with celiac disease eat gluten (a protein found in wheat, rye and barley), their body mounts an immune response that attacks the small intestine. These attacks lead to damage on the villi, small fingerlike projections that line the small intestine, that promote nutrient absorption.
Celiac disease may occur at any point in life after people start eating gluten. Symptoms vary for each person. However, some common symptoms include:
- Nausea and vomiting
- Diarrhea
- Unintended weight loss
- Abdominal pain and bloating
- Loose, greasy, or bad-smelling stool
- Tooth enamel damage
- Fatigue
- Joint or bone pain
Treatment for celiac disease requires patients to eat a gluten-free diet. Without this, complications may occur, including:
- Osteoporosis
- Coronary artery disease
- Infertility
- Migraines
- Epilepsy
