Anokion has announced positive data from a completed Phase I trial investigating KAN-101 for coeliac disease treatment.

The trial (NCT04248855), termed ACeD, was a randomised, double-blind, placebo-controlled study that investigated 41 individuals with coeliac disease on a gluten-free diet across two cohorts of single-ascending dose and multi-ascending dose.

Early findings from the study demonstrated safety and tolerance of KAN-101, along with inducing functional tolerance of gliadin-specific T cells following gluten challenge. KAN-101 can specifically target parts of the immune system responsible for gluten immune reaction as opposed to conventional broad-sweeping immunosuppressants.

In the multi-ascending dose segment, patients were administered with KAN-101 on days 1,4, and 7 at dose levels of 0.15, 0.3, and 0.6 mg/kg or placebo. A three-day gluten challenge then followed on day 15.

The recent findings announced by the Swiss company demonstrated that KAN-101 was cleared from systemic circulation within approximately six hours in the multi-ascending cohort, and effects lasted up to three weeks after treatment. KAN-101 also increased gliadin-specific, tetramer+ T cells and, after the gluten challenge, led to a dose-dependent modulation of interleukin-2. 

The company plans to continue with Phase II initiation in 2023, with initial data expected in early 2024.

Coeliac disease is an autoimmune condition that affects around 2 million people in the US, according to the National Institutes of Health. Whilst there is no cure, current treatments explore suppressing immune reactions, managing symptoms, and alleviating long-term health effects. “As a highly burdensome condition with no disease-modifying therapies available today, KAN-101 could be a game changer for patients, with durable treatment effects observed following administration,” said Deborah Geraghty, Ph.D., chief executive officer of Anokion.