On January 6, 2022, Anokion SA, a clinical-stage biotechnology company, announced successful completion of its Phase 1 clinical trial evaluating KAN-101 for the treatment of celiac disease, with promising results.

KAN-101 is an investigational drug that aims to re-educate the immune cells that drive celiac disease, so they do not respond to gluten antigens, while leaving the healthy components of the immune system intact.

Anokion reports that the primary goals of this study were achieved. KAN-101 was shown to be safe and well-tolerated in single and multiple doses in celiac disease patients.

Results further demonstrated “immunological human proof-of-concept” for reducing the body’s immune response to gluten in patients with celiac disease.

Anokion expects to present its detailed findings later this year and launch enrollment for a Phase 2 clinical trial in the second half of 2022.

This tremendous news is encouraging for the celiac disease community because it means KAN-101 has succeeded in getting one step closer to reaching the market, where an estimated 90% of all other proposed treatments in Phase 1 have failed.

If KAN-101 successfully completes its upcoming Phase 2 trial, it will be 3x more likely to reach the market.

The last hurdle KAN-101 would have to clear to gain FDA approval is the successful completion of a larger Phase 3 clinical trial to confirm its safety, dosage, and efficacy in celiac disease patients. There are currently six celiac disease drugs in Phase 2 trials and only one in Phase 3.

Utilizing its iQualifyCeliac platform—which targets patient candidates to speed enrollment and improve clinical trial retention—the Celiac Disease Foundation was a major recruiter for Anokion’s KAN-101 Phase 1 clinical trial, the ACeD Study.

The Foundation’s goal is to accelerate research for better treatments and, eventually, a cure for celiac disease. The staggering expense of bringing a new drug to market discourages drug development for conditions like celiac disease. Our patient recruitment services, including iQualifyCeliac, lower the costs of drug development by partnering with our celiac disease community to ensure the success of clinical trial patient outreach and enrollment.

Together with our patient community, we are proud to have contributed to the success of the Phase 1 clinical trial for KAN-101 and look forward to sharing results from the planned Phase 2 trial.