BOSTON, Sept. 18, 2023 (GLOBE NEWSWIRE) -- LAPIX Therapeutics, Inc. (“LAPIX”), a biopharmaceutical company focused on developing novel, orally bioavailable immune system restoration therapies for autoimmune diseases, today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S.

2023年9月18日，波士顿（GLOBE NEWSWIRE）-生物制药公司LAPIX Therapeutics，Inc.（“LAPIX”）专注于开发用于自身免疫性疾病的新型口服生物可利用免疫系统恢复疗法，今天宣布已获得批准其研究性新药（IND）申请来自美国。

Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for its first-in-class, immune tolerance restoration small molecule, LPX-TI641, for the treatment of multiple sclerosis (MS). The clinical trial is expected to begin dosing in 4Q 2023. “We believe in empowering and restoring the immune system to fight disease and the FDA clearance of our IND application for LPX-TI641 represents momentum in our technology and scientific approach,” said Anas M.

美国食品和药物管理局（FDA）为其一流的免疫耐受恢复小分子LPX-TI641启动1期临床试验，用于治疗多发性硬化症（MS）。该临床试验预计将于2023年4月开始给药。“我们相信授权和恢复免疫系统以对抗疾病，FDA批准我们的LPX-TI641 IND申请代表了我们技术和科学方法的势头，”Anas M.说。

Fathallah, Ph.D., Chief Executive Officer and co-founder of LAPIX. “We are excited to begin our first-in-human clinical study evaluating LPX-TI641 and its potential to be a first of its kind non-immune suppressive therapeutic option for autoimmune diseases.” The Phase 1 trial is designed to evaluate the safety, tolerability, and pharmacokinetics of LPX-TI641 in healthy subjects after a single ascending dose.

Fathallah博士，LAPIX的首席执行官和联合创始人。“我们很高兴开始我们的首次人体临床研究，评估LPX-TI641及其作为自身免疫性疾病的首例非免疫抑制治疗选择的潜力。”第一阶段试验旨在评估LPX-TI641在单次递增剂量后在健康受试者中的安全性，耐受性和药代动力学。

Data from the Phase 1 study along with LPX-TI641’s antigen-agnostic versatility could allow for the rapid pivot to other autoimmune indications such as rheumatoid arthritis. “We aspire to transform how the medical field treats patients diagnosed with serious and complex immune diseases and we are deeply committed to helping as many people as possible,” added Dr.

来自1期研究的数据以及LPX-TI641的抗原不可知的多功能性可以允许快速枢轴到其他自身免疫适应症，例如类风湿性关节炎。博士补充说：“我们渴望改变医疗领域如何治疗被诊断患有严重和复杂免疫疾病的患者，并深深致力于帮助尽可能多的人。”。

Fathallah. “Our antigen-agnostic immune tolerance restoration approach centered on developing Tim (T-cell immunoglobulin and mucin domain) agonists, along with our in-depth knowledge of immunology and immune tolerance are the.

法塔拉。“我们以开发Tim（T细胞免疫球蛋白和粘蛋白结构域）激动剂为中心的抗原不可知的免疫耐受恢复方法，以及我们对免疫学和免疫耐受的深入了解是。