Phase 2 Dosing Initiated in the Global Phase 1b/2 ACeD-it Clinical Trial of KAN-101 for the Treatment of Celiac Disease; Data Expected in 2024

On-track to Initiate Global Phase 2a SynCeD Histological Study of KAN-101 by Year-end

Enrollment Completed Early in MoveS-it Phase 1 SAD/MAD Clinical Trial of ANK-700 in Multiple Sclerosis; Preliminary Data Support ANK-700 Safety, Impact on Antigen-specific Immune Tolerance and Bystander Suppression to Related Myelin Antigens

Anokion SA, a clinical-stage biotechnology company focused on treating autoimmune disease by restoring normal immune tolerance, today reported progress for its clinical-stage programs, KAN-101 and ANK-700. The company’s lead product candidate, KAN-101, is being evaluated for the treatment of celiac disease, and its second candidate, ANK-700, is being evaluated for the treatment of multiple sclerosis (MS).

“2023 has been a year of significant progress for Anokion, marked by the execution of our two clinical-stage programs, KAN-101 and ANK-700, and clinical data that validate our approach to re-educating critical immune pathways in the body using durable, disease-modifying medicines,” said Deborah Geraghty, Ph.D., chief executive officer. “Based on the strength of the Phase 1 clinical data with KAN-101, the first agent to modulate gluten induced IL-2, an established biomarker associated with symptomatic responses to gluten exposure in celiac disease, we are excited to begin the first of two global Phase 2 trials after establishing additional safety at higher doses in Phase 1b earlier this year. We anticipate this trial, with the second Phase 2a histology study, will further establish clinical proof-of-concept of KAN-101 as a treatment for celiac disease, an indication with no approved therapeutic options today.”

Dr. Geraghty continued, “In parallel, we’ve completed enrollment in our MoveS-it trial assessing ANK-700 for MS, which not only further confirms the safety of the Anokion platform, but demonstrates antigen-specific trends in tolerance and bystander suppression, a highly sought after mechanism for treating complex autoimmune diseases like MS. I am incredibly proud of the accomplishments of this team and look forward to advancing both KAN-101 and ANK-700 as potential first-in-class treatments.”

KAN-101 Phase 2 Dosing Initiated

Anokion has initiated patient dosing in the global Phase 2 portion of the ACeD-it (Assessment of KAN-101 in Celiac Disease and Immune Tolerance) clinical trial in patients with celiac disease. The ACeD-it study consists of two parts: Phase 1b is an open-label, multiple ascending dose study design to assess the safety, and tolerability of KAN-101 in celiac patients at dose levels of KAN-101 higher than those studied in the Phase 1 clinical trial; Phase 2 is a double-blind, placebo-controlled study designed to evaluate the effect of KAN-101 on the gluten induced IL-2 biomarker and celiac symptoms. 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.

The primary endpoint of the ACeD-it Phase 2 is to assess the impact on gluten induced IL-2 biomarker responses. Key secondary endpoints include assessing the incidence of adverse events and pharmacokinetic parameters in patients treated with KAN-101. In addition, an assessment of celiac symptomatic improvements following gluten challenge will be performed. The ACeD-it study will be run at sites in the US, Australia and New Zealand. Anokion anticipates reporting topline data in 2024.

ANK-700 Phase 1 Trial Completes Enrollment

Anokion has completed patient enrollment early in the second and final MAD cohort of its MoveS-it (Multiple Sclerosis Study of ANK-700 to Assess Safety and Immune Tolerance) clinical trial to evaluate ANK-700 for the treatment of patients with multiple sclerosis. MoveS-it is a randomized, double-blind, placebo-controlled Phase 1 study evaluating ANK-700 for the treatment of patients with relapsing remitting multiple sclerosis (RRMS). MS is a demyelinating disease of the CNS, in which the immune system attacks the myelin sheath in the brain and spinal cord. RRMS is the most common type of MS, characterized by recurring episodes of new or worsening symptoms. Anokion has designed ANK-700 to re-educate the immune system by inducing antigen-specific tolerance to myelin-based autoantigens to reduce neuroinflammation in the brain and spinal cord.

Safety data from both the SAD and MAD cohorts supports that ANK-700 is safe and well-tolerated at all dose levels tested through the dose escalation period. Further, preliminary biomarker data from the MAD cohorts displays trends in antigen-specific immune tolerance and evidence of bystander suppression to related myelin antigens, which is critical to treating complex autoimmune diseases like MS.

The study will continue with a 12-month safety follow-up expected to complete in the first half of 2024. Anokion anticipates reporting full results from its MoveS-it clinical trial in the second half of 2024.

About Anokion

Anokion SA is a clinical-stage Swiss biotechnology company that aims to make a meaningful difference in the lives of patients suffering from autoimmune diseases by restoring normal immune tolerance. The company is focused on both prevalent and rare autoimmune diseases, including celiac disease, multiple sclerosis, and type 1 diabetes. Anokion’s distinct approach leverages the company’s immune-based platform, which targets natural pathways in the liver to restore immune tolerance and address the underlying cause of autoimmune disease. For more information, please visit anokion.com.

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