Promising Celiac Disease Drug KAN-101 Proves Safe and Tolerable in Phase 1 Testing

Celiac.com 08/17/2023 - KAN-101, the most recent drug designed to induce immune tolerance to wheat gluten, has proven safe and tolerable in the Phase 1 stage of testing. Now the hard work starts.

The drug has shown promise for treating celiac disease, an autoimmune condition where the body reacts negatively to gluten in the small intestines. The drug, developed by Anokion, targets the liver to promote immune tolerance to gluten in people with celiac disease.

KAN-101 Demonstrated Safety and Pharmacokinetic Potential

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In the first-in-human phase 1 ACeD trial, KAN-101 demonstrated safety and pharmacokinetic potential. The trial involved 41 adult patients with biopsy-confirmed celiac disease, all with the HLA-DQ2.5 genotype, which is associated with celiac disease. The patients received different doses of KAN-101 through intravenous administration.

No Serious Adverse Events or Dose-limiting Toxicities

Results showed that the drug had acceptable safety, with no serious adverse events or dose-limiting toxicities. Common mild to moderate side effects included nausea, diarrhea, abdominal pain, and vomiting, which were consistent with celiac disease symptoms. KAN-101 rapidly cleared from the patients' systems within approximately 6 hours, and there was no accumulation on repeated dosing.

Deborah Geraghty, CEO of Anokion, expressed excitement about the drug's potential to induce immune tolerance to gluten, providing a durable treatment effect for celiac disease patients. With celiac disease currently lacking an FDA-approved treatment option, KAN-101 could be a game-changer.

The research team plans to further analyze KAN-101's efficacy and safety in human patients, particularly with biomarker responses from a gluten challenge, at doses of 0.6 mg/kg or higher in those with celiac disease. 

If successful, KAN-101 could significantly impact the lives of those with celiac disease by providing a viable and effective treatment option.

While the early testing is encouraging, it's a long haul from Phase 1 to full approval, and so far, no drug designed to treat celiac disease has made the journey. The failures are legion. So, celiac sufferers should take this news with a grain of salt. 

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