Eli Lilly To Launch Head-to-head Study Comparing Once-monthly Injectable Emgality With Nurtec ODT

礼来将开展头对头研究,比较每月注射一次的Emgality与Nurtec ODT

2021-06-15 20:00:26 RTTNews


Eli Lilly and Co. (LLY) announced Tuesday that it will conduct a head-to-head study comparing once-monthly injectable Emgality (galcanezumab-gnlm) with Nurtec ODT (rimegepant), an orally disintegrating tablet patients take every other day. This study will help to advance the science of migraine treatment and aid the understanding of calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) compared to oral CGRP receptor antagonists in the prevention of migraine. CGRP is a protein in the brain thought to play a key role in migraine. Emgality binds to this protein, preventing it from attaching to the CGRP receptors, whereas Nurtec ODT blocks the receptor for this protein. This study aims to answer important questions that will help clinicians and patients make more informed treatment decisions on the path to more migraine-free days. The study, which is the first head-to-head clinical trial comparing two medications targeting CGRP, is a multi-site, randomized, double-blind, double-dummy, parallel-group Phase 4 study in patients who meet the International Classification of Headache Disorders (ICHD) criteria for a diagnosis of episodic migraine with or without aura. There will be two treatment arms: Emgality 120 mg once-monthly injection, with an initial 240 mg loading dose, and Nurtec ODT 75 mg, taken every other day. The study's primary endpoint is 50% reduction in monthly migraine headache days. Enrollment is expected to begin later this year. Emgality is a monoclonal antibody that selectively binds to CGRP and was approved by the FDA in September 2018 for the preventive treatment of migraine in adults. In June 2019, Emgality was approved by the FDA for the treatment of episodic cluster headache in adults. For comments and feedback contact: editorial@rttnews.com
礼来公司(LLY)周二宣布,将进行一项头对头的研究,比较每月一次的可注射Emgality(galcanezumab-gnlm)和Nurtec ODT(rimegepant)(患者每隔一天服用一次的口腔崩解片)。 本研究将有助于提高偏头痛治疗的科学性,并有助于了解降钙素基因相关肽(CGRP)单克隆抗体(mAb)与口服CGRP受体拮抗剂在偏头痛预防中的作用。 CGRP是大脑中一种被认为在偏头痛中起关键作用的蛋白质。Emgality与该蛋白结合,阻止其与CGRP受体结合,而Nurtec ODT则阻断该蛋白的受体。这项研究旨在回答一些重要的问题,这些问题将帮助临床医生和患者在通往更多无偏头痛日的道路上做出更明智的治疗决定。 该研究是首次比较两种以CGRP为靶点的药物的头对头临床试验,是一项多部位、随机、双盲、双假人、平行组的第4期研究,研究对象为符合国际头痛疾病分类(ICHD)诊断有或无先兆的发作性偏头痛标准的患者。 将有两个治疗臂:Emgality 120毫克,每月一次,初始负荷剂量240毫克,和Nurtec ODT 75毫克,每隔一天服用。该研究的主要终点是每月偏头痛天数减少50%。预计今年晚些时候开始招生。 Emgality是一种选择性结合CGRP的单克隆抗体,于2018年9月被美国FDA批准用于成人偏头痛的预防性治疗。2019年6月,Emgality被美国FDA批准用于治疗成人发作性丛集性头痛。 如需评论和反馈,请联系:editorial@rttnews.com