<p><font size="3">（以下英文内容来自chiasma官网，中文内容来自谷歌翻译，略作修改）</font></p><p><font size="3">        Chiasma完成了奥曲肽胶囊的国际第三阶段试验（商品名暂命名为Mycapssa®），其结果已发表在“临床内分泌学和代谢杂志”（Journal of Clinical Endocrinology and Metabolism）上。</font></p><p><font size="3">        Chiasma正在根据与美国食品和药物管理局达成的特殊协议评估协议进行第三阶段临床试验，该协议是奥曲肽胶囊产品候选物，用于肢端肥大症成人患者的维持治疗。该试验被称为“CHIASMA OPTIMAL”（多国的奥曲肽胶囊与安慰剂的对比治疗），是一项全球性，随机，双盲，安慰剂对照，为期9个月的试验。预计将招收50名成人肢端肥大症患者。该试验旨在评估与安慰剂相比，维持奥曲肽胶囊生化反应的患者比例。该公司于2017年第三季度启动了CHIASMA OPTIMAL的项目，并预计到2019年底该三期临床试验将公布最终数据。</font></p><p><font size="3">        Chiasma还正在根据欧洲药品管理局（EMA）接受的协议进行国际第三阶段临床试验，该协议是该公司奥曲肽胶囊产品候选物，用于肢端肥大症成人患者的维持治疗。该试验被称为MPOWERED™（维持奥曲肽胶囊患者与注射相比 - 反应耐久性的评估），是一项全球性，随机化，开放标签和积极控制的15个月试验。预计最多可招募150名成人肢端肥大症患者，其中期望在接受奥曲肽胶囊或可注射生长抑素受体配体（奥曲肽或兰瑞肽）6个月后，至少80名奥曲肽胶囊应答患者随机分组， ，然后再追踪九个月。只有6个月末在研究中被认定为反应者（IGF-1 <1></p><p><span style="font-size: 16px;"></span><br></p><p><font size="2">Chiasma completed an international Phase 3 trial of octreotide capsules (conditionally trade named Mycapssa®), the results of which have been published in the Journal of Clinical Endocrinology and Metabolism. </font></p><p><font size="2">Chiasma is conducting a Phase 3 clinical trial under a Special Protocol Assessment agreement reached with the U.S. Food and Drug Administration for its octreotide capsules product candidate for the maintenance therapy of adult patients with acromegaly. The trial, referred to as “CHIASMA OPTIMAL” (Octreotide capsules vs. Placebo Treatment In MultinationAL centers), is a global, randomized, double-blind, placebo-controlled, nine-month trial. It is expected to enroll 50 adult acromegaly patients. The trial is designed to evaluate the proportion of patients who maintain their biochemical response to octreotide capsules compared to placebo. The company initiated enrollment in CHIASMA OPTIMAL in the third quarter of 2017 and anticipates the release of top-line data from this Phase 3 clinical trial by the end of 2019.</font></p><p><font size="2">Chiasma also is conducting an international Phase 3 clinical trial under a protocol accepted by the European Medicines Agency (EMA) for the company’s octreotide capsules product candidate for the maintenance therapy of adult patients with acromegaly. The trial, referred to as MPOWERED™ (Maintenance of Acromegaly Patients with Octreotide Capsules Compared with Injections – Evaluation of Response Durability), is a global, randomized, open-label and active-controlled, 15-month trial. It is expected to enroll up to 150 adult acromegaly patients, of which it expects to randomize at least 80 patients who are responders to octreotide capsules following a six-month run-in to either octreotide capsules or injectable somatostatin receptor ligands (octreotide or lanreotide), and then followed for an additional nine months. Patients are only randomized into the 9-month randomized controlled phase of MPOWERED </font></p><p><font size="2">if they are qualified as responders (IGF-1 <1></p><!--1--><p></p><!--1--><p></p>