索马鲁肽治疗NASH获突破性疗法认定 肥胖症疗法降(2)

在1期临床试验中，最高剂量的AM833与索马鲁肽联用，在治疗开始后20周就能够将患者的体重降低17.1%，而索马鲁肽单药疗法这时只能将患者体重降低9.5%。同时，这一组合疗法表现出与索马鲁肽单药疗法相似的安全性和耐受性。

▲最高剂量AM833作为单药（左图）或与索马鲁肽联用（右图），分别降低患者体重10.8%和17.1%（图片来源：诺和诺德官网）

诺和诺德计划在明年启动3期临床试验，检验这一组合疗法在治疗肥胖症患者时的疗效。该公司指出，目前在治疗肥胖症方面，减肥手术（bariatric surgery）虽然效果最好，但是通常只对调节饮食或锻炼不起作用，或因为肥胖导致严重健康问题的患者使用。目前市场上的减肥药物的疗效，与减肥手术相比仍然有很大的差距。而诺和诺德肥胖症研发管线的药物，有望进一步提高减肥药物降低体重的效果，填补目前减肥药与减肥手术之间的空缺。

▲诺和诺德肥胖症研发管线有望填补减肥药与减肥手术之间的空缺（图片来源：诺和诺德官网）

IL-6抗体2b期临床试验结果积极

今年6月，诺和诺德斥资21亿美元收购了Corvidia Therapeutics公司及其主打候选药物ziltivekimab。Ziltivekimab是一款全人源化白细胞介素-6（IL-6）单克隆抗体。用于在慢性肾病（CVD）患者中降低主要心血管不良事件（MACE）风险，这些患者同时患有动脉粥样硬化性心血管疾病（ASCVD）和炎症。

在已经完成的2b期临床试验中，ziltivekimab作为单药疗法，在所有剂量都显著降低患者的炎症生物标志物超敏C反应蛋白（hsCRP）水平，同时表现出良好的安全性和耐受性。基于2b期临床试验的积极结果，诺和诺德将在2021年下半年启动3期临床试验，检验ziltivekimab降低患者心血管事件风险的效果。

参考资料：

[1] Financial report for the period 1 January 2020 to 30 September 2020. Retrieved October 30, 2020, from https://www.novonordisk.com/content/dam/nncorp/global/en/investors/irmaterial/quarterly_financial_reports/2020/20201030_Q3-CA.pdf

[2] Investor presentation First nine months of 2020. Retrieved October 30, 2020, from https://www.novonordisk.com/content/dam/nncorp/global/en/investors/irmaterial/investor_presentations/2020/20201030_Q3%202020-conference-call-presentation.pdf

[3] Semaglutide 2.4 mg shows superior weight loss versus placebo in the phase 3 trials STEP 2 and STEP 3, thereby successfully completing the programme. Retrieved October 30, 2020, from https://www.globenewswire.com/news-release/2020/06/12/2047467/0/en/Semaglutide-2-4-mg-shows-superior-weight-loss-versus-placebo-in-the-phase-3-trials-STEP-2-and-STEP-3-thereby-successfully-completing-the-programme.html

[4] Novo Nordisk reports weight loss of 14.9% (16.9% if taken as intended) in STEP 1 trial. Retrieved October 30, 2020, from https://www.globenewswire.com/news-release/2020/06/04/2043954/0/en/Novo-Nordisk-reports-weight-loss-of-14-9-16-9-if-taken-as-intended-in-STEP-1-trial.html

[5] Semaglutide 2.4 mg demonstrates superior and sustained weight loss versus placebo and in addition a 17.4% weight loss after 68 weeks in STEP 4 trial. Retrieved October 30, 2020, from https://www.globenewswire.com/news-release/2020/05/13/2032852/0/en/Semaglutide-2-4-mg-demonstrates-superior-and-sustained-weight-loss-versus-placebo-and-in-addition-a-17-4-weight-loss-after-68-weeks-in-STEP-4-trial.html

[6] Novo Nordisk successfully completes AM833 phase 2 trial and phase 1 combination trial with AM833 and semaglutide in obesity. Retrieved October 30, 2020, from https://www.globenewswire.com/news-release/2020/06/18/2050266/0/en/Novo-Nordisk-successfully-completes-AM833-phase-2-trial-and-phase-1-combination-trial-with-AM833-and-semaglutide-in-obesity.html

[7] R&D investor presentation. June 19, 2020 https://www.novonordisk.com/content/dam/Denmark/HQ/investors/irmaterial/investor_presentations/2020/RD_event_presentation_Final.pdf