CAMBRIDGE, Mass. & LAUSANNE, Switzerland--(BUSINESS WIRE)--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)..

剑桥，马萨诸塞州。＆LAUSANNE，瑞士-（商业线）-Anokion SA，一家临床阶段生物技术公司，专注于通过恢复正常的免疫耐受来治疗自身免疫性疾病，今天报告其临床阶段计划KAN-101和ANK-700。该公司的主要候选产品KAN-101正在评估治疗乳糜泻，其第二名候选人ANK-700正在评估治疗多发性硬化症（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.

“2023年是失巢凋亡取得重大进展的一年，其特点是我们执行了两项临床阶段计划KAN-101和ANK-700，以及临床数据验证了我们使用持久性重新教育体内关键免疫途径的方法，疾病改善药物，“首席执行官Deborah Geraghty博士说。

“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.

“基于KAN-101第一阶段临床数据的强度，KAN-101是第一个调节麸质诱导的IL-2的药物，这是一种与乳糜泻面筋暴露症状反应相关的既定生物标志物，我们很高兴开始第一个在今年早些时候在第1b阶段以较高剂量建立额外安全性之后，进行了两项全球2期临床试验。

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.”.

我们预计这项试验将通过第二阶段2a组织学研究，进一步建立KAN-101作为乳糜泻治疗概念的临床证据，这是目前尚未批准治疗方案的指征。

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.

Geraghty博士继续说：“与此同时，我们已经完成了评估ANK-700 MS的MoveS it试验，这不仅进一步证实了Anokion平台的安全性，而且还展示了耐受性和旁观者抑制的抗原特异性趋势，一种治疗MS等复杂自身免疫性疾病的备受追捧的机制。

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.”.

我为这个团队的成就感到难以置信的骄傲，并期待将KAN-101和ANK-700作为潜在的一流治疗方法。

KAN-101 Phase 2 Dosing Initiated

KAN-101第二阶段剂量开始

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.

Anokion已经在乳糜泻患者的ACeD it（KAN-101在乳糜泻和免疫耐受中的评估）临床试验的全球2期部分开始患者给药。ACeD it研究由两部分组成：第1b阶段是一项开放标签，多次递增剂量研究设计，用于评估KAN-101在腹腔患者中的安全性和耐受性，其剂量水平高于阶段研究的KAN-101。1项临床试验；第2阶段是一项双盲，安慰剂对照研究，旨在评估KAN-101对面筋诱导的IL-2生物标志物和腹腔症状的影响。

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..

KAN-101是一种新型免疫耐受疗法，包括使用公司专有的肝脏靶向技术将已建立的谷蛋白抗原递送至肝脏和免疫系统。。

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.

ACeD it阶段2的主要终点是评估对谷蛋白诱导的IL-2生物标志物应答的影响。关键的次要终点包括评估用KAN-101治疗的患者的不良事件发生率和药代动力学参数。此外，还将进行面筋挑战后腹腔症状改善的评估。

The ACeD-it study will be run at sites in the US, Australia and New Zealand. Anokion anticipates reporting topline data in 2024..

ACeD it研究将在美国，澳大利亚和新西兰的网站上进行。Anokion预计在2024年报告顶级数据。。

ANK-700 Phase 1 Trial Completes Enrollment

ANK-700第一阶段试验完成注册

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).

Anokion在其第二次也是最后一次MAD队列中早期完成了患者登记。it（ANK-700多发性硬化症研究评估安全性和免疫耐受性）临床试验评估ANK-700治疗多发性硬化症患者。MoveS是一项随机，双盲，安慰剂对照的1期研究，评估ANK-700治疗复发缓解型多发性硬化症（RRMS）患者。

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..

MS是CNS的脱髓鞘疾病，其中免疫系统攻击脑和脊髓中的髓鞘。RRMS是最常见的MS类型，其特征在于新症状或恶化症状的反复发作。Anokion设计了ANK-700，通过诱导对基于髓鞘的自身抗原的抗原特异性耐受来减少脑和脊髓中的神经炎症，从而重新教育免疫系统。。

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..

来自SAD和MAD队列的安全性数据支持ANK-700在剂量递增期间测试的所有剂量水平下都是安全且耐受性良好的。此外，来自MAD队列的初步生物标志物数据显示抗原特异性免疫耐受的趋势和旁观者抑制相关髓鞘抗原的证据，这对于治疗复杂的自身免疫疾病如MS是至关重要的。。

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.

该研究将继续进行为期12个月的安全随访，预计将于2024年上半年完成。Anokion预计将在2024年下半年报告其MoveS it临床试验的全部结果。

About Anokion

关于失巢凋亡

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 SA是一家临床阶段的瑞士生物技术公司，旨在通过恢复正常的免疫耐受，在患有自身免疫性疾病的患者的生活中产生有意义的改变。该公司专注于流行和罕见的自身免疫性疾病，包括乳糜泻，多发性硬化症和1型糖尿病。

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..

Anokion的独特方法利用该公司基于免疫的平台，该平台针对肝脏中的自然途径，以恢复免疫耐受并解决自身免疫性疾病的根本原因。欲了解更多信息，请访问anokion.com。。