Enrollment Completed in ACeD Phase 1 Trial of KAN-101 for Celiac Disease; Statistical Evidence of Biological Activity Across Multiple Endpoints Demonstrated with No Safety Signals Observed
KAN-101 Clinical Data to be Presented at Medical Conference in First Half of 2022; Initiation of Phase 2 Trial Expected in Second Half of 2022
Multi-Ascending Dose Cohort Expansion Initiated in Phase 1 Trial of ANK-700 for Multiple Sclerosis
Cambridge, Mass. and Lausanne, Switzerland, January 6, 2022 – 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).
“Since our inception, Anokion has been focused on leveraging novel scientific insights in the biology of autoimmunity to create durable, disease-modifying medicines for individuals with autoimmune disorders that work by re-educating critical immune pathways in the body. Our commitment to that mission resulted in significant progress in 2021 across all aspects of our portfolio and business,” said Deborah Geraghty, Ph.D., chief executive officer. “Our achievements position us for an exciting 2022, with plans to advance KAN-101 into a Phase 2 clinical trial for celiac disease later this year based on compelling clinical data and initiating enrollment in the multiple ascending dose portion of our MoveS-it study assessing ANK-700 for multiple sclerosis. In parallel, we are advancing our research pipeline to bring forward multiple development candidates, including a novel program for Type I diabetes. I am incredibly proud of the accomplishments by our team, particularly as we navigated the ongoing impacts of the COVID-19 pandemic, and believe we have an opportunity to meaningfully change how autoimmune diseases are treated. We look forward to sharing more progress throughout 2022.”
KAN-101 Clinical Update
Anokion has completed patient enrollment in its ACeD clinical trial, a randomized, double-blind, placebo-controlled Phase 1 study evaluating KAN-101 for the treatment of individuals with celiac disease, an autoimmune disorder driven by inappropriate immune responses to gluten peptides that can result in severe, life-altering symptoms. KAN-101 aims to re-educate immune cells to not respond to gluten antigens. The study enrolled a total of 41 individuals on a gluten-free diet in both the single-ascending dose (SAD) and multi-ascending dose (MAD) cohorts. The primary endpoint of the ACeD trial is to assess the safety and tolerability of KAN-101, with secondary endpoints to assess KAN-101 serum concentrations and pharmacokinetics. In addition, exploratory endpoints include assessing cytokines critical to both innate and adaptive immunity, T cell responses, as well as other serum cytokines and celiac disease symptoms.
In the Phase 1 trial, statistical evidence of biological activity was observed across multiple clinical endpoints and disease biomarkers, with demonstration of immunological human proof-of-concept in patients with celiac disease. In addition, KAN-101 was well-tolerated with no safety signals observed. Anokion plans to present detailed Phase 1 results at a medical meeting in the first half of 2022, followed by initiation of a Phase 2 clinical trial in individuals with celiac disease in the second half of 2022.
ANK-700 Clinical Update
Anokion has initiated patient enrollment in the MAD portion of its MoveS-it clinical trial, 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 in order to reduce neuroinflammation in the brain and spinal cord. The company previously presented preclinical data in mouse models of MS that support the potential for ANK-700 to meaningfully slow disease progression in individuals with MS.
ANK-700 has been well-tolerated in the MoveS-it clinical trial with no safety signals observed to date. Initiation of the MAD cohort enrollment follows completion of the first two SAD cohorts in the trial, with the third SAD cohort actively enrolling patients. Anokion anticipates reporting initial results from its MoveS-it clinical trial in the second half of 2022.
In addition, Anokion announces that the company and Bristol Myers Squibb have mutually agreed to terminate the Option Support Agreement established in 2016 with Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb Company.
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.
THRUST Strategic Communications