CAMBRIDGE, Mass., March 8, 2024 /PRNewswire/ -- Regor Therapeutics Group ('Regor'), a clinical-stage global biopharmaceutical company powered by a cutting-edge drug discovery engine and differentiated clinical development pipeline, today announced that its Phase 2 trial of the highly selective oral GLP-1 agonist RGT-075 is initiated in adults with obesity or overweight with weight-related comorbidities and has First Patient First Visit (FPFV) on Mar 08, 2024.

马萨诸塞州剑桥市，2024年3月8日/PRNewswire/--Regor Therapeutics Group（“Regor”），一家临床阶段的全球生物制药公司，由尖端的药物发现引擎和差异化的临床开发管道提供动力，今天宣布，其高选择性口服GLP-1激动剂RGT-075的2期临床试验开始于肥胖或超重伴体重相关合并症的成年人，并于2024年3月8日首次患者首次就诊（FPFV）。

The topline results for this Phase 2 trial are expected to be announced in the second half of 2024. 'The initiation of the Phase 2 trial marks an important milestone in the development of RGT-075 as we believe it could represent a convenient and potentially meaningful alternative to the currently available weight loss treatments,' said Michael Grimm, M.D., Ph.D., Head of Metabolic Diseases at Regor.

第二阶段试验的最终结果预计将于2024年下半年公布。”Regor代谢疾病负责人迈克尔·格里姆（MichaelGrimm）医学博士说，第二阶段试验的启动标志着RGT-075开发过程中的一个重要里程碑，因为我们认为它可能是目前可用的减肥疗法的一个方便且潜在有意义的替代品。

'RGT-075 is designed to be administered orally once daily as a monotherapy or as part of a potential oral combination treatment for obesity. Phase 1 clinical data showed promising exploratory body weight trends despite short treatment duration,' added Dr. Grimm..

“RGT-075被设计为每天口服一次，作为单一疗法或作为肥胖潜在口服联合治疗的一部分。格里姆博士补充说，第一阶段的临床数据显示，尽管治疗时间短，但仍有希望探索体重趋势。。

About the RGT-075 development program

关于RGT-075开发计划

The Phase 2 multicenter, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of once-daily oral RGT-075 compared with placebo in adult patients with obesity or overweight with weight-related comorbidities.

第二阶段多中心，随机，双盲，安慰剂对照研究旨在评估每日一次口服RGT-075与安慰剂相比在肥胖或超重伴体重相关合并症的成年患者中的安全性，耐受性，药代动力学（PK）和药效学（PD）。

Approximately 60 adult participants with a BMI ≥ 27 kg/m2 and ≤ 45 kg/m2 will be enrolled and randomized to RGT-075 or placebo. The treatment will last 12 weeks; all participants on RGT001-075 will be given RGT-075 once daily (QD) titrated up over 6 weeks, then being maintained with the target dose for 6 weeks.

大约60名BMI≥27 kg/m2且≤45 kg/m2的成年参与者将被招募并随机分配到RGT-075或安慰剂组。治疗将持续12周；RGT001-075上的所有参与者将每天一次（QD）给予RGT-075滴定超过6周，然后维持目标剂量6周。

Topline data from the Phase 2 study are expected to be announced in the second half of 2024..

第二阶段研究的主要数据预计将于2024年下半年公布。。

About RGT-075

关于RGT-075

RGT-075 is an oral-available, once-daily, small molecule GLP-1R full agonist discovered and developed by Regor for the treatment of metabolic diseases, such as type-2 diabetes mellitus and overweight/obesity. Regor completed its Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) studies.

RGT-075是Regor发现和开发的一种口服小分子GLP-1R全激动剂，每日一次，用于治疗代谢性疾病，如2型糖尿病和超重/肥胖。Regor完成了其第一阶段单次递增剂量（SAD）和多次递增剂量（MAD）研究。

RGT-075 was safe and clinically well-tolerated in clinical trials completed to date..

RGT-075在迄今为止完成的临床试验中安全且临床耐受性良好。。

About Regor Therapeutics Group

关于Regor Therapeutics Group

Regor Therapeutics Group ('Regor') is founded in 2018 by a team of scientists with a proven track record in drug discovery and executive leadership covering full cycle of drug discovery and development. By leveraging its industry-leading core strength in rCARD™ (Computer Accelerated Rational Discovery), Regor has completed 8 PCCs inhouse, with 5 INDs filed, validating Regor's highly efficient ecosystem for accelerated discovery of innovative therapeutic agents..

Regor Therapeutics Group（“Regor”）成立于2018年，由一群在药物发现和执行领导方面拥有良好记录的科学家组成，涵盖了药物发现和开发的整个周期。通过利用其在rCARD™（Computer Accelerated Rational Discovery）方面业界领先的核心优势，Regor在内部完成了8个PCC，并提交了5个IND，验证了Regor高效的生态系统，以加速创新治疗剂的发现。。

Regor's in-house pipeline encompasses leading assets in metabolism, oncology and auto-immunity, with two leading assets: 1) RGT-075, an orally bioavailable small molecule GLP1R full agonist with best-in-class potential for obesity & beyond; and 2) RGT-419B, a unique CDK4+ inhibitor showing outstanding single agent responses in refractory ER+/HER2- breast cancer patients..

Regor的内部管道包括代谢，肿瘤学和自身免疫方面的领先资产，有两项领先资产：1）RGT-075，一种口服生物可利用的小分子GLP1R全激动剂，具有最佳的肥胖潜力；2）RGT-419B，一种独特的CDK4+抑制剂，在难治性ER+/HER2乳腺癌患者中显示出出色的单药反应。。

With a strong focus on excellence in pharmaceutical research and global competitiveness, Regor aspires to build a world-class innovation engine that promotes a winning culture of scientific excellence, strong teamwork driven by results and delivery with shared accountability and successes.

Regor专注于卓越的药物研究和全球竞争力，致力于建立世界一流的创新引擎，促进卓越科学文化的形成，以成果和交付为驱动的强大团队合作，共同承担责任和取得成功。

IR Contact:Investor Relations and Communicationsir@regor.com

IR联系人：投资者关系和Communicationsir@regor.com

SOURCE Regor Therapeutics Group

SOURCE Regor Therapeutics集团