Anokion Announces Publication in The Lancet Gastroenterology & Hepatology Highlighting Safety and Preliminary Effects of KAN-101 in Celiac Disease in its ACeD Phase 1 Clinical Trial

KAN-101 represents the first agent to modulate the IL-2 biomarker associated with symptomatic responses to gluten exposure in celiac patients

KAN-101 advancing in a Phase 1b/2 clinical trial in celiac disease and immune tolerance

Excerpt from the Press Release:

CAMBRIDGE, Mass. & LAUSANNE, Switzerland–(BUSINESS WIRE)–Anokion SA, a clinical-stage biotechnology company focused on treating autoimmune disease by restoring normal immune tolerance, today announced that The Lancet Gastroenterology & Hepatology has published clinical data on KAN-101 from the Phase 1 ACeD (Assessment of KAN-101 in Celiac Disease) Trial, which support the favorable safety of KAN-101 and signals of dose-dependent reactivity to gluten and induction of immune tolerance in patients with celiac disease. KAN-101 is a novel immune tolerance therapy, which encompasses an established gluten antigen delivered to the liver and immune system using the company’s proprietary liver-targeting technology.

As highlighted in the publication, in a completed randomized, double-blind, placebo-controlled Phase 1 study in 41 patients with confirmed celiac disease, KAN-101 was safe and well-tolerated in patients treated. No adverse events above a grade 2, no serious adverse events, no dose-limiting toxicities, and no maximum tolerated dose were observed. In addition, treatment with KAN-101 followed by a three-day oral gluten challenge resulted in a reduction in immune reactivity to gluten. KAN-101 administration at three dose levels (0.15, 0.3, and 0.6 mg/kg) led to a dose-dependent modulation of gluten induced IL-2, a reduction in gliadin-specific T cells, and a favorable impact on gut homing CD8+ T cells. Consistent with its liver-targeting mechanism, KAN-101 showed rapid systemic clearance in pharmacokinetic analyses of approximately six hours, with no accumulation upon repeat dosing.

“Celiac disease is a serious autoimmune disease triggered by ingestion of gluten for which there are no approved therapeutic treatments available. The preliminary reduction in immune gluten sensitivity generated by KAN-101 has the potential to significantly decrease the daily dietary burden of this disease, while the favorable safety profile will help ensure that KAN-101 can make the greatest impact for this population,” said Deborah Geraghty, Ph.D., chief executive officer of Anokion.

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