ImmuneSensor Therapeutics, a clinical-stage biotherapeutics company focused on the development of first- and best-in-class inhibitors and agonists targeting the cGAS-STING pathway to address diverse peripheral and CNS indications in inflammation, autoimmunity and oncology, announced that it has received Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) clearance by the Australian Therapeutic Goods Administration (TGA) to initiate a Phase 1 randomized placebo-controlled, double-blinded clinical trial of its lead anti-inflammatory and autoimmunity drug candidate, IMSB301, in healthy volunteers.

Immunsensor Therapeutics是一家临床阶段生物治疗公司，专注于开发针对cGAS-STING途径的一流和一流的抑制剂和激动剂，以解决炎症，自身免疫和肿瘤学中的各种外周和中枢神经系统适应症，宣布已获得澳大利亚治疗用品管理局（TGA）的人类研究伦理委员会（HREC）批准和临床试验通知（CTN）批准，以在健康志愿者中启动其主要抗炎和自身免疫候选药物IMSB301的1期随机安慰剂对照双盲临床试验。

IMSB301 is a novel, orally available small molecule cGAS inhibitor that is being developed for the treatment of inflammatory and autoimmune diseases. “Receiving HREC approval and CTN clearance for the first clinical trial of our novel cGAS inhibitor is a significant milestone for ImmuneSensor as we pursue our goal to bring innovative therapeutic interventions to those battling autoimmune and other inflammatory diseases,” said Tom Dubensky, Ph.D., ImmuneSensor’s president and chief executive officer.

IMSB301是一种新型的口服小分子cGAS抑制剂，正在开发用于治疗炎症和自身免疫性疾病。Immunsensor总裁兼首席执行官汤姆·杜本斯基（TomDubensky）博士说：“我们的新型cGAS抑制剂的首次临床试验获得了HREC的批准和CTN的批准，这对于Immunsensor来说是一个重要的里程碑，因为我们追求的目标是为那些与自身免疫和其他炎症性疾病作斗争的人带来创新的治疗干预措施。”。

“The initial dose finding portion of our Phase 1 trial of IMSB301 in healthy volunteers will provide important early safety and target engagement data that will inform rapid advancement to Phase 1b/2 clinical studies in patients with severe inflammatory diseases, including Aicardi Goutières syndrome (AGS), a rare inflammatory disease that is specifically driven by chronic activation of the cGAS pathway in these patients, and in defined patient populations with systemic lupus erythematosus (SLE).”About the IMSB301 Phase 1 Clinical ProgramThe Phase 1 randomized, placebo-controlled, double-blind clinical trial is designed to evaluate the safety and toler.

“我们在健康志愿者中进行的IMSB301第一阶段试验的初始剂量发现部分将提供重要的早期安全性和目标参与数据，这些数据将为严重炎症性疾病患者（包括Aicardi-Goutières综合征（AGS））的1b/2期临床研究提供快速进展的信息。AGS是一种罕见的炎症性疾病，特别是由这些患者以及系统性红斑狼疮（SLE）患者的cGAS途径的慢性激活所驱动。”关于IMSB301第一阶段临床计划第一阶段随机，安慰剂对照，双盲临床试验旨在评估其安全性和耐受性。