更新于：2024-07-08
Licogliflozin
更新于：2024-07-08
概要
基本信息
在研机构- |
最高研发阶段终止临床2期 |
首次获批日期- |
最高研发阶段(中国)终止 |
特殊审评- |
关联
13
项与 Licogliflozin 相关的临床试验一项评估口服tropifexor（LJN452）和licogliflozin（LIK066）联合治疗和单药治疗对比安慰剂在伴肝纤维化的非酒精性脂肪性肝炎（NASH）成年受试者中的疗效、安全性和耐受性的随机、双盲、平行组、多中心研究（ELIVATE）
本研究的目的为根据NASH临床研究网络（CRN）组织学评分，在伴肝纤维化（2期或3期）的NASH受试者中比较tropifexor和licogliflozin联合治疗、各单药治疗与安慰剂组治疗的疗效、安全性和耐受性。
开始日期2021-07-21 |
申办/合作机构 Aptuit (Verona) Srl [+3] |
A Randomized, Double-blind, Parallel-group, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Oral Tropifexor (LJN452) & Licogliflozin (LIK066) Combination Therapy and Each Monotherapy, Compared With Placebo for Treatment of Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis.(ELIVATE)
Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor & licogliflozin combination therapy and each monotherapy, compared with placebo for treatment of adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.
开始日期2019-12-30 |
A Randomized, Double-blind, Dose-finding Study to Evaluate the Change in Weight After 12 Weeks Treatment With 4 Doses of LIK066 Compared to Placebo in Japanese Patients With Obesity Disease
The purpose of the study is to evaluate the efficacy, tolerability and safety of LIK066 to support dose selection for Phase 3 development in Japanese adults with obesity disease.
开始日期2017-12-07 |
100 项与 Licogliflozin 相关的临床结果
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100 项与 Licogliflozin 相关的转化医学
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100 项与 Licogliflozin 相关的专利（医药）
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14
项与 Licogliflozin 相关的文献（医药）2022-12-12·Angewandte Chemie (International ed. in English)
Cu Single Atom Nanozyme Based High‐Efficiency Mild Photothermal Therapy through Cellular Metabolic Regulation
Article
作者: Wen, Ding ; Wang, Man ; Chang, Mengyu ; Zhao, Yanli ; Liu, Yuhui ; Hou, Zhiyao ; Li, Chunxia ; Lin, Jun
Abstract:
Upregulation of heat shock proteins (HSPs) drastically compromises the treatment effect of mild photothermal therapy (PTT). Herein, we designed a polyporous Cu single atom nanozyme (Cu SAzyme) loaded with licogliflozin (LIK066) for HSP‐silencing induced mild PTT. On one hand, LIK066 inhibits glucose uptake by shutting sodium‐dependent glucose transporter (SGLT) “valve”, effectively blocking the energy source for adenosine triphosphate (ATP) generation. Without sufficient energy, cancer cells cannot synthesize HSPs. On the other hand, Cu SAzyme presents extraordinary multienzyme activities to induce reactive oxygen species (ROS) storm formation, which can damage the existing HSPs in cancer cells. Through a two‐pronged strategy of SGLT inhibitor and ROS storm, LIK066‐loaded Cu SAzyme shows high efficiency for comprehensive removal of HSPs to realize mild PTT.
2022-11-01·Diabetes & metabolic syndrome
Dose-dependent efficacy and safety of licogliflozin on obese adults: A systematic review and meta-analysis of randomized controlled trials
Review
作者: Abo-Elnour, Dina Essam ; Salama, Moaz Khaled ; Abdalla, Yomna Emad ; Abdelhaleem, Ibrahim Abdelmonaem ; Elboraay, Toka ; Hassan, Rehab Yosri ; Zaki, Alaa Mohamed
BACKGROUND AND AIM:
Licogliflozin is a dual SGLT1/2 inhibitor acting on the intestine and kidney by reducing glycemic and calorie content. We aimed to determine the efficacy and safety of licogliflozin on Anthropometric measurements and cardiometabolic parameters in obese participants.
METHODS:
We systematically searched the PubMed, Cochrane Library, Scopus, and Web of Science databases for randomized controlled trials (RCTs) relevant to our eligibility criteria. We performed a subgroup analysis based on licogliflozin doses and the diabetic state of participants. This meta-analysis was registered on PROSPERO (CRD42021286936).
RESULTS:
We identified five RCTs with a total of 905 obese and overweight participants. All participants had a weight reduction of 2.43 kg (95% CI: -3.17 to -1.69, p < 0.00001) compared with placebo. The mean difference in HbA1c of obese diabetic patients was (MD: -0.30%; 95% CI: -0.45, -0.16); I2 = 46% in favor of licogliflozin. The incidence of serious adverse events, all-cause mortality, headache, nausea, and vomiting were similar between licogliflozin and placebo (p = 0.72, 0.97, 0.09, 0.53, and 0.89, respectively). However, there was a higher incidence of diarrhea in the licogliflozin group.
CONCLUSION:
We found that licogliflozin was safe and tolerable. It reduces body weight significantly. Moreover, it improves glycemic control and other cardiometabolic parameters.
2022-07-01·Nature medicine1区 · 医学
Licogliflozin for nonalcoholic steatohepatitis: a randomized, double-blind, placebo-controlled, phase 2a study
1区 · 医学
Article
作者: Mendonza, Anisha E ; Klein, Samuel ; Harrison, Stephen A ; Sicard, Eric ; Smith, William B ; Klarenbeek, Naomi ; Badman, Michael K ; Alpenidze, Diana ; Ukomadu, Chinweike ; He, YanLing ; Ben-Ari, Ziv ; Manghi, Federico Perez ; Martic, Miljen ; Katchman, Helena ; Tanner, Sandra ; Chen, Chi-Yi ; Zuckerman, Eli ; Pachori, Alok ; Ravussin, Eric ; Zhang, Yiming ; Kao, Sheena ; Aizenberg, Diego ; Cheng, Pin-Nan ; Ma, Shenglin ; Charatcharoenwitthaya, Phunchai
Nonalcoholic steatohepatitis (NASH) is a common chronic liver disease that may advance to fibrosis and lead to mortality; however, no pharmacotherapy is currently available. We tested the hypothesis that inhibition of both the sodium-glucose cotransporters 1 and 2 with licogliflozin would lead to improvement in NASH. A total of 107 patients with phenotypic or histologic NASH were randomized (1:2:2) to receive oral administration of either placebo (n = 21), licogliflozin 30 mg (n = 43) or 150 mg (n = 43) once daily for 12 weeks. Licogliflozin 150 mg showed a significant 32% (80% confidence interval (CI): 21-43%; P = 0.002) placebo-adjusted reduction in serum alanine aminotransferase after 12 weeks of treatment, the primary endpoint of the study. However, the 30 mg dose of licogliflozin did not meet the primary endpoint (placebo-adjusted reduction 21% (80% CI: 7-32%; P = 0.061)). Diarrhea occurred in 77% (33 of 43), 49% (21 of 43) and 43% (9 of 21) of patients treated with licogliflozin 150 mg, 30 mg and placebo, respectively, which was mostly mild in severity. No other major safety concerns were identified. Treatment with 150 mg licogliflozin led to reductions in serum alanine aminotransferase in patients with NASH. Studies of longer duration and in combination with drugs that have different mechanisms of action are needed to validate these findings and to define a role of licogliflozin as a therapeutic option for NASH. ClinicalTrials.gov identifier: NCT03205150.
5
项与 Licogliflozin 相关的新闻（医药）2023-05-30
·研发客
// 被赛诺菲放弃的索格列净，成为FDA批准的首款SGLT1/2双靶点抑制剂，在心衰方面的疗效全面超越SGLT2单靶点抑制剂。一向对慢性病用药临床研究数据要求苛刻的FDA，最近却对一款新药格外开恩。上周五Lexicon Pharmaceuticals宣布，其产品索格列净（sotagliflozin）获FDA上市批准，用于降低成人患者因风险因素导致发生心血管事件死亡、心力衰竭而住院或接受急救的风险。索格列净递交的两项研究SOLOIST和SCORED，试验对象都仅限于2型糖尿病患者。出人意料的是，FDA最终却未限定使用者是否患糖尿病，也未限定左心室射血分数（LVEF）。指标全面超越单靶点同类产品此次FDA将索格列净适应症范围扩大至研究以外人群，猜测一方面是基于同类产品的研究经验，更重要的应该还在于其展示出SGLT1/2双重抑制剂对比于SGLT2单靶点抑制剂的疗效优势。近年，SGLT2抑制剂作为降糖药开发的同时，意外被发现对心力衰竭有预防和治疗作用，成为新药研发领域的一项重要突破。自2020年以来，已有多款SGLT2抑制剂心衰适应症获FDA批准，如恩格列净、达格列净等，适应症覆盖也逐渐从射血分数降低扩大到射血分数保留的心衰。FDA对心衰药物的要求是“三好学生”，获批产品必须在三个主要指标上体现出治疗获益，包括总MACEs事件风险率、总心血管死亡事件风险率、总心衰住院风险率。而在上述三项指标上，索格列净的表现均对比安慰剂组有显著差异，同时数据较已上市的“列净”类产品，也有较大改善（见下表）。来源|上海研健整理除此以外，索格列净最明显的进步之处，体现在降低中风和心梗事件发生风险上。从数据看，目前已上市的SGLT2抑制剂并不能在该指标上让患者获益，而索格列净降低两项事件的发生率均超过30%。赛诺菲没有坚持到最后SGLT1/2双靶点抑制剂的设计理念，是利用双通道同时减少消化道对葡萄糖的吸收，以及肾小管对葡萄糖的重吸收。以此进一步减少糖尿病患者的葡萄糖吸收量，并为伴有肾损伤的人群提供更优治疗选择。赛诺菲曾对上述产品在糖尿病领域的开发寄予厚望。2015年11月，Lexicon和赛诺菲签订合作开发协议，获得索格列净全球开发和商业化权利。该合作首付款3亿美元，此外还有14亿美元的里程碑付款及一定比例的销售分成。赛诺菲当时做出这样的决定，并不能说是赌徒心态，毕竟SGLT2单靶点抑制剂已诞生多款重磅炸弹。谁料后来SGLT1/2双靶点抑制剂在糖尿病适应症上的开发会如此坎坷。索格列净的首个适应症上市申请就遭FDA当头一棒。在与赛诺菲达成合作后，索格列净完成了数项与1型糖尿病治疗有关的研究，并于2019年4月获欧盟批准，用于接受最佳胰岛素疗法但血糖控制仍不达标的1型糖尿病成人患者。然而，FDA却因担心可能导致糖尿病酮症酸中毒（DKA）风险而拒绝了索格列净的上市申请。事实上，SGLT2单靶点抑制剂未获批1型糖尿病适应症，也主要因为这一原因，索格列净未能将其克服。而索格列净在2型糖尿病上开展的几项临床研究，结果也是喜忧参半。在最能说明SGLT1/2双靶点抑制剂优势的肾损伤患者研究中，索格列净相比于选择性SGLT2抑制剂，在伴有轻、中度肾损伤的糖尿病患者（损伤程度小于DKD3a）中显示出不错的降糖效果，但未能给伴有更严重肾损伤（DKD3b及以上）的2型糖尿病患者带来额外的临床收益。这成为压垮赛诺菲信心的最后一根稻草。2019年赛诺菲宣布与Lexicon终止索格列净项目合作，为此还向Lexicon支付了2.6亿美元的分手费。而Lexicon也因缺少支持，无法继续推进已经启动的多项3期临床研究，其中包括SOLOIST和SCORED两项大型临床研究，只得在2021年使用中期分析结果向FDA递交心衰适应症上市申请。面对索格列净时隔4年获批心衰适应症的消息，不知赛诺菲此时会作何感想？根据GlobalData的预测，到2028年仅全球8个主要市场（美国、法国、德国、意大利、西班牙、英国、日本和中国），心衰药物市场年复合增长率达19.5%，预计2028年市场规模将达221亿美元。国内有同类产品在研除了已获批上市的索格列净，全球还有两款SGLT1/2双靶点抑制剂进入临床研究阶段，分别是诺华的LIK066以及上海研健的YG1699。其中上海研健的YG1699是国内唯一进入临床研究的SGLT1/2双靶点抑制剂。该公司提到，2022年YG1699已获FDA首肯，可直接在美国启动心衰适应症的2期临床研究。研健公司研发负责人李成海说：“YG1699与索格列净（同期所获得的数据）相比具有多重优势，它在安全窗、人体PK暴露量及生物活性等方面都远好于索格列净。对于业内普遍关注的索格列净酮症酸中毒（DKA）问题，YG1699在已经完成的T1DM治疗2期临床研究中，在人为增加DKA风险因素的条件下，未观察到有受试者出现该不良反应。并且该研究结果同时显示，YG1699的疗效显著好于头对头比较的达格列净。”（具体数据见下图）图中：纵坐标是餐后血糖，横坐标是时间。深灰色线是对照组，绿线是达格列净10mg，橘色和红色分别是YG1699的10mg和25mg。图中显示：未用药和使用达格列净的两组，在90分钟内血糖是上升的。90分钟开始，达格列净起效开始降糖。而YG1699的10mg和25mg均在吃药后立刻起效，并保持血糖平稳。试验证明：YG1699在降糖和控制餐后血糖平稳方面优于达格列净。根据研健提供的资料，YG1699具有更高的人体PK暴露量（见下表），在25mg用药剂量时，血药浓度即可达到索格列净400mg剂量时的4倍。 来源|上海研健整理还值得一提的是，研健现任首席医学官（CMO）Pablo Lapuerta，之前就曾在Lexicon公司任全球执行副总裁兼CMO，主导了索格列净产品的多项临床开发。索格列净在心衰领域的获批，增加了国内SGLT1/2双靶点抑制剂研发者的信心。但接下来公司着手启动全球大规模3期临床研发，还需要投入大量的资金和人力支持。未来SGLT1/2双靶点抑制剂还能在哪些适应症上崭露头角，包括YG1699未来的临床研究进展，这些都值得期待。编辑 | 姚嘉yao.jia@PharmaDJ.com总第1892期访问研发客网站可浏览更多文章www.PharmaDJ.com
引进/卖出医药出海
2022-12-12
The prevalence of nonalcoholic steatohepatitis has been rising since the past few years, which prompts the growing demand for treatment options. The increasing prevalence of Nonalcoholic Steatohepatitis and the growing research and development activities drive the market. The Companies developing the potential therapies in the last stage of development include Madrigal Pharmaceuticals, Inventiva, Boehringer Ingelheim, and several others.
LAS VEGAS, Dec. 12, 2022 /PRNewswire/ -- DelveInsight's
'
Nonalcoholic Steatohepatitis Pipeline Insight – 2022
' report provides comprehensive global coverage of available, marketed, and pipeline nonalcoholic steatohepatitis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the nonalcoholic steatohepatitis pipeline domain.
Key Takeaways from the Nonalcoholic Steatohepatitis Pipeline Report
DelveInsight's nonalcoholic steatohepatitis pipeline report depicts a robust space with
130+ active players working to develop
150+ pipeline therapies for nonalcoholic steatohepatitis treatment.
Key nonalcoholic steatohepatitis companies such as
Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Mitsubishi Tanabe Pharma, Chemomab Therapeutics, NuSirt Biopharma, HK inno. N, Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Merck Sharp & Dohme LLC, Cascade Pharmaceuticals, Hepion Pharmaceuticals, Chipscreen Biosciences, Boston Pharmaceuticals, Bristol-Myers Squibb, Sunshine Lake Pharma, GSK plc., Future Medicine, Gilead Sciences, ENYO Pharma, Histogen, and others are evaluating nonalcoholic steatohepatitis drugs to improve the treatment landscape.
Promising nonalcoholic steatohepatitis pipeline therapies in various stages of development include
TERN-101, SNP-610, LJN452 (tropifexor + licogliflozin), PXL065, ALS-L1023, PF-06865571 + PF-05221304, PF-06835919, PF-06865571, ORMD-0801, Norucholic acid, NNC0194-0499, MN-001, MK-3655, MET642, MET409, LPCN 1144, LIK066, Leronlimab, ALN-HSD, MT-3995, CM101, Leu-Mit-Sil (NS-0200), IN-A010, Efruxifermin (EFX), Efinopegdutide, EDP-305, JKB-122, CS0159 (Linafexor), CRV431, Chiglitazar sodium, BOS-580, BMS-986263, HEC96719, GSK4532990, FM101, Firsocostat, EPY001a, Emricasan, BMS-986036, BIO89-100, BI 456906, BFKB8488A, AXA1125, ASC 41, GS-9674 (Cilofexor), ZSP1601, and others.
In
November 2022,
Sagimet Biosciences announced positive interim data from its
Phase IIb clinical trial (FASCINATE-2) with
denifanstat, a fatty acid synthase (FASN) inhibitor, in non-alcoholic steatohepatitis patients. Data showed statistically significant improvements across key markers of NASH, reinforcing results observed in earlier studies, including statistically significant reductions in markers of liver fat, inflammation, and fibrosis. There were no treatment-related serious adverse events, with the majority of adverse events mild to moderate in nature (Grade 1 and 2). Additional interim data are expected in early 2023.
In
November 2022,
Inventiva announced that the
United States Patent and Trademark Office granted a patent (U.S. Patent No. 11,504,380) that protects the use of
lanifibranor for the treatment of cirrhotic patients at risk of progressing from compensated stage to decompensated stage. This patent will expire on November 8, 2039. This patent further expands the intellectual property protection of lanifibranor in the United States for use in patients with cirrhotic NASH.
In
October 2022,
Galectin Therapeutics, Inc. reported the positive outcome of its second data and safety monitoring board (DSMB) meeting for
NAVIGATE, its seamless, adaptive,
phase IIb/III study of
belapectin in patients with liver cirrhosis caused by non-alcoholic steatohepatitis (NASH). The objective of this second independent DSMB was further to review the emerging tolerance and safety profiles of belapectin. Based on its deliberation, the DSMB concluded that NAVIGATE could continue as designed, without modifications.
In
September 2022,
Inventiva and
Chia Tai-Tianqing Pharmaceutical Group entered into a licensing and collaboration agreement to develop and commercialize
lanifibranor, if approved, for the treatment of nonalcoholic steatohepatitis and potentially other metabolic diseases in mainland China, Hong Kong, Macau, and Taiwan.
In
June 2022,
Poxel SA announced that the
U.S. Patent and Trademark Office (PTO) has issued to Poxel US Patent No. 11319313, which represents a new patent for
PXL065, a novel, proprietary deuterium-stabilized R-stereoisomer of pioglitazone which is being investigated in Phase II stage of clinical trial evaluation for the treatment of Nonalcoholic steatohepatitis (NASH).
In
May 2022,
Pfizer Inc. announced the
U.S. Food and Drug Administration (FDA) had granted
Fast Track designation to Pfizer's investigational combination therapy for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis: ervogastat (PF-06865571, a diacylglycerol O-acyltransferase 2 inhibitor, or DGAT2i) and clesacostat (PF-05221304, an acetyl-CoA carboxylase inhibitor, or ACCi).
In
May 2022,
Hepion Pharmaceuticals, Inc. announced that it has entered into a clinical
collaboration with
HepQuant, a Denver-based, privately held company with novel, proprietary investigational technology for evaluating liver function and health in patients with chronic liver diseases. Hepion will incorporate the HepQuant 'SHUNT' test into a dedicated Phase IIb clinical trial in presumed NASH F3 subjects.
In
February 2022, the US
Food and Drug Administration (FDA) granted a
Fast-Track Designation to
Axcella Therapeutics' AXA1125 to treat non-alcoholic steatohepatitis (NASH) with liver fibrosis.
In
January 2022,
LISCure Biosciences announced that it had executed a research collaboration agreement with
Mayo Clinic for new drug development for rare liver diseases. LISCure Biosciences Inc. has executed a research collaboration agreement with US based-Mayo Clinic for new drug development for rare liver diseases.
Request a sample and discover the nash drugs in development 2022 @
Nonalcoholic Steatohepatitis Pipeline 2022 Report
The nonalcoholic steatohepatitis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage nonalcoholic steatohepatitis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the nonalcoholic steatohepatitis clinical trial landscape.
Nonalcoholic Steatohepatitis Overview
Nonalcoholic steatohepatitis (NASH) is a type of liver inflammation and damage caused by fat buildup. It is one of several conditions known as nonalcoholic fatty liver disease. Nonalcoholic fatty liver disease is classified into two types: isolated fatty liver, in which only fat accumulates, and nonalcoholic steatohepatitis, in which fat, inflammation, and liver cell damage occur.
NASH does not usually cause symptoms. Most people with NASH feel fine and are unaware that they have it. As NASH progresses and liver damage worsens, a patient may experience fatigue, weight loss, general weakness, and acne in the upper right part of the belly. Screening for nonalcoholic fatty liver disease in the general population is not advised. It is usually considered after discovering unexplained liver enzyme levels, or imaging reveals hepatic steatosis. A patient's medical history, a physical exam, and tests for nonalcoholic steatohepatitis are used by doctors.
Want to discover how the Nash treatment pipeline will look like? Request for sample @
NASH Drug Pipeline 2022
A snapshot of the Nonalcoholic Steatohepatitis Pipeline Drugs mentioned in the report:
Want to know how nash dash the pipeline race is for new agents? Download the sample page @
NASH Clinical Trials
Nonalcoholic Steatohepatitis Therapeutics Assessment
The
nonalcoholic steatohepatitis pipeline report proffers an integral view of nonalcoholic steatohepatitis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration.
Scope of the Nonalcoholic Steatohepatitis Pipeline Report
Coverage: Global
Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Therapeutics Assessment By Route of Administration: Intravenous, Parenteral, Oral, Subcutaneous
Therapeutics Assessment By Molecule Type: Antibody, Biologic, Cell therapy, Peptide, Protein, Small molecule
Therapeutics Assessment By Mechanism of Action: Adiponutrin inhibitor, Diacylglycerol O acyltransferase inhibitor, Adiponutrin modulator, RNA interference, Glucagon like peptide 1 receptor agonist, Ornithine decarboxylase stimulant, Farnesoid X-activated receptor agonist, Thyroid hormone receptor beta agonist, Mitochondrial membrane transport protein modulator, Thyroid hormone receptor beta agonists, Peroxisome proliferator-activated receptor alpha agonist
Key Nonalcoholic Steatohepatitis Companies:Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Mitsubishi Tanabe Pharma, Chemomab Therapeutics, NuSirt Biopharma, HK inno. N, Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Merck Sharp & Dohme LLC, Cascade Pharmaceuticals, Hepion Pharmaceuticals, Chipscreen Biosciences, Boston Pharmaceuticals, Bristol-Myers Squibb, Sunshine Lake Pharma, GSK plc., Future Medicine, Gilead Sciences, ENYO Pharma, Histogen, and others.
Key Nonalcoholic Steatohepatitis Pipeline Therapies: TERN-101, SNP-610, LJN452(tropifexor + licogliflozin), PXL065, ALS-L1023, PF-06865571 + PF-05221304, PF-06835919, PF-06865571, ORMD-0801, Norucholic acid, NNC0194-0499, MN-001, MK-3655, MET642, MET409, LPCN 1144, LIK066, Leronlimab, ALN-HSD, MT-3995, CM101, Leu-Mit-Sil (NS-0200), IN-A010, Efruxifermin (EFX), Efinopegdutide, EDP-305, JKB-122, CS0159 (Linafexor), CRV431, Chiglitazar sodium, BOS-580, BMS-986263, HEC96719, GSK4532990, FM101, Firsocostat, EPY001a, Emricasan, BMS-986036, BIO89-100, BI 456906, BFKB8488A, AXA1125, ASC 41, GS-9674 (Cilofexor), ZSP1601, and others.
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NASH Treatment Pipeline
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临床2期引进/卖出快速通道
2022-12-02
·药智网
我国脂肪肝患者约1.5亿，且在不断增加，NASH（非酒精性脂肪性肝炎）是脂肪肝中比较严重的类型。据悉，有1.1亿轻度脂肪肝患者，可以通过饮食及锻炼好转，但是上千万中度重度NASH患者不能通过该方法恢复。且NASH需要终生用药，市场规模大。预测在2030年内，NASH将超过乙肝，成为威胁人类健康的又一杀手。预计国际NASH的市场规模，在2025年能达到350-400亿美元。不过，好消息是Madrigal公司最近披露，旨在治疗NASH的新药Resmetirom首个全球III期临床研究积极的试验数据，给NASH患者带来新希望的同时，也预示着NASH领域的新药开发即将迎来新一轮“黄金期”。6家药企布局一览雅创医药：FXR激动剂HPG-1860雅创医药的HPG-1860，国内研发进度最快的FXR激动剂之一。具有高度选择性的非胆汁酸结构的FXR激动剂。FXR通过调控胆汁酸合成相关的基因表达，成为胆汁酸稳态的关键控制器。研究表明NASH疾病进展中FXR的表达下调，且FXR在炎症调节中的作用已被广泛关注并研究。HPG1860在临床前研究和早期临床试验中表现出卓越的FXR靶向激活特性和良好的安全性。不过，由于FXR激活剂主要改变脂肪代谢途径，有增加血脂的副作用，因此心血管疾病患者不宜使用，即使能成功上市后市场受限。歌礼制药：FXR激动剂ASC40歌礼制药发布公告称，其研发的FXR激动剂ASC42用于治疗原发性胆汁性胆管炎(PBC)的一项药物－药物相互作用(DDI)研究临床试验申请，已获得FDA批准，该研究将为后续在中国、美国和欧盟开展ASC42 III期临床试验提供更多支持。不过，FXR激动剂在不同临床试验中，均出现剂量依赖的皮肤瘙痒和血脂异常，这些是FXR激活后的靶效应。目前，面临的主要挑战是优化FXR激动剂的结构并确定最佳剂量，在减轻不良反应的同时，保持确定性的肝组织学改善和临床疗效，这是一个有待解决的两难选择。广东众生药业：ZSP1601该企业在NASH领域布局了6个产品，分别是ZSP1601、ZSP0678、ZSYM008及RCYM001、RAY001以RAY002布局了覆盖肝脂肪，炎症，纤维化等不同作用靶点，并且有联合用药潜力的产品管线。其中，ZSP1601已完成Ib/IIa期临床试验，试验获得了积极结果，达到了主要终点，支持ZSP1601片继续开展IIb期临床试验，在国内研发进展位于第一梯队。深圳君圣泰：HTD1801其研发的新药全球同步开发，且已有2个品种进入到临床II期，并获得美国FDA的快速审评通道资格认定2项和孤儿药认定1项。拓臻生物：FXR激动剂TERN101主要针对NASH、肝纤维化、肝细胞癌等慢性肝脏疾病的全新疗法，去年成功登陆纳斯达克。TERN-101正是来自于礼来的授权许可。与其他FXR激动剂相比，TERN-101具有更好的组织特异性，在肝脏分布高，最大限度减少肠道通路的激活，从而减少瘙痒和不良脂质变化等副作用，提高了药物的耐受性。另外，还有SSAO抑制剂TERN-201、THR-β激动剂TERN-501、以及一款GLP-1R激动剂。韩国LG-Chem VAP-1抑制剂LR20056LG化学从国内药捷安康获得授权的LR20056，是一种新型、强效、选择性和不可逆的半衰期敏感胺氧化酶（SSAO，又称血管粘附蛋白-1（VAP-1））抑制剂，拟作为非酒精性脂肪性肝炎（NASH）的口服治疗药物，正在美国进行临床I期实验。图1 NASH研发十大药企布局图片来源：pharmacodia global数据库NASH药物研发策略目前，NASH靶向药物治疗策略主要可以分为四大类：第一类，靶向改善胰岛素敏感性的代谢靶点，抑制参与新脂肪生成的不同酶，或改善线粒体对脂肪酸的利用；第二类，靶向炎症或细胞损伤靶点，抑制炎症细胞的招募或阻断炎症信号传导，减少氧化和/或内质网压力，或抑制肝细胞凋亡；第三类，调节胆汁酸肠道肝脏循环和信号，或改变肠道微生物群的肝肠轴靶标；最后一类，直接针对肝星状细胞的抗纤维化目标，减少肝脏中胶原蛋白的沉积，减少肝纤维化。表1总结了具有代表性的五款药物。图2 NASH及纤维化通过临床II期以上的药物图片来源：《自然》综述doi.org/10.1038/s41574-021-00507-z图3临床实验中的NASH代表药物及靶点一览图片来源：Nature Reviews Gastroenterology&Hepatology,18(6),373-392.靶向胆汁酸受体研究发现，胆汁酸作为信号分子与受体结合，在ＮＡＦＬＤ／ＮＡＳＨ发生、进展和消退中起关键作用。２０１５年ＦＬＩＮＴ试验中期结果“奥贝胆酸（ＯＣＡ）通过激活法尼醇Ｘ受体（ＦＸＲ）可以降低ＮＡＳＨ患者的ＮＡＦＬＤ活动性评分（ＮＡＳ）及纤维化“程度”引起业界关注。FXR激动剂奥贝胆酸，虽然已在临床III期研究中达到FDA设定的临床终点。但其是否能够被批准上市，尚有很大的不确定性。更重要的问题是：是否值得继续开发更好的FXR小分子激动剂？答案似乎是肯定的，但摆脱骚痒这样的副作用，也可能只是研究者的一厢情愿。加上其它可能的肝毒性，这就限制药物能使用的剂量，其总体疗效就很有限。最近发布了两个FXR激动剂，EDP-305和MET409的临床II期数据，但瘙痒仍然是很大的问题。2019年9月25日，Enanta Pharmaceuticals发布了另一个FXR激动剂，EDP-305的临床2a研究（ARGON-1）数据。该研究测试了两个剂量（1mg和2.5mg）的EDP-305，高剂量组的肝酶水平下降了28单位/升，而安慰剂组下降了15单位/升。结果刚刚超过有统计学意义的阈值，与OCA临床测试中减少28单位/升的指标一致。接受高剂量EDP-305的患者肝脂肪（MRI-PDFF）在统计学上显著减少。45%受试者是MRI-PDF应答者，即取得≥30%的脂肪减少。EDP-305也表现出强大的靶标参与度，如C4的减少以及FGF-19和ALP的增加；也观察到了GGT的强力降低。总体而言，EDP-305总体上是安全的，大多数与治疗相关的不良事件（TEAEs）是轻度至中度。最常见的（≥5%）包括瘙痒（pruritus），胃肠道（GI）相关症状（恶心，呕吐，腹泻），头痛和头晕。迄今为止，在所有研究中，在400多个接受EDP-305的受试者中，都观察到了一致的安全性特征。至于EDP-305在这个为期12周的临床2a研究中的耐受性，则不令人乐观：在2.5mg剂量组中，大约51%的受试者存在瘙痒，而在1mg手臂中，低于10%的受试者出现瘙痒；大多数瘙痒是轻度或中度。因瘙痒导致的停药率分别为1.8%（1 mg剂量组）和20.8%（2.5 mg剂量组）。在2.5mg剂量组中，所有停药都是由于中度瘙痒。2020年8月27日，位于美国加州圣地亚哥的Metacrine，Inc.，发布了为期12周的随机，安慰剂控制的MET409临床1b研究最终的积极结果，MET409是该公司的非胆汁酸FXR激动剂，用于治疗NASH。靶向PPARs过氧化物酶体增殖物激活受体(PPAR)，是核激素受体超家族的配体依赖性转录因子，包括PPARα、PPARγ和PPARβ/δ三种亚型。其中，PPAR-α的激活可降低甘油三酯水平并参与能量稳态的调节，而PPAR-β/δ的激活增强了脂肪酸代谢。PPARγ激动剂吡格列酮可在改善胰岛素抵抗基础上促进脂肪重新分布，减轻肝脂肪变性、炎症和肝纤维化。PPARα和PPARγ激动剂saroglitazar于2020年3月在印度获批上市，用于治疗非肝硬化NASH，是全球首个获批用于NASH治疗的药物，其既可减少肝内脂肪含量，降低肝酶水平，又可通过调节糖脂代谢降低心血管疾病危险因素，适用于合并他汀类药物不能控制的糖尿病和高脂血症的NASH患者。近期，印度研究报告，saroglitazar(4mg/d)治疗9个月可降低NAFLD患者的血清总胆固醇和肝酶水平，改善肝脏硬度。临床研究显示，PPARα和PPARδ双重激动剂elafibranor和泛PPAR激动剂lanifibranor等均可降低NAFLD患者的血脂水平和改善肝脏组织病理学。但这个靶点最近也是困难重重：苏州泽璟暂停“ZG0588非酒精性脂肪性肝炎适应症临床前研究、临床研究及药学研究”项目的原因中就强调：PPAR激动剂在治疗NASH的临床研究中疗效低于预期，如2020年5月，Genfit公司宣布其PPAR激动剂elafibranor治疗非酒精性脂肪肝（NASH）的III期临床研究未能达到预先设定的主要终点。靶向肝脏特异性甲状腺受体（THRs）甲状腺激素调节肝脏甘油三酯和胆固醇代谢的很多过程，甲状腺受体的两种亚型THRα和THRβ在大多数组织中都有表达，其中THRβ是在肝脏中表达的主要形式，选择性更高。Resmetirom是目前在NASH适应症上研发进展最快的THRβ激动剂，今年1月底，上文提到的Madrigal Pharmaceuticals宣布药物在III期研究中达到了主要终点和关键的次要终点，患者肝脏脂肪和致动脉粥样硬化的脂质实现了“显著的、临床相关的”减少，且安全性良好。图4 Resmetirom优化合成路径图片来源：J.Med.Chem.2014,57,3912-3923国内公司自主研发的产品中，进展最快的是拓臻生物的TERN-501。今年3月已经在美国启动了单药以及与FXR激动剂TERN-101联合用药的II期临床。靶向GLP-1受体胰高血糖素样肽-1（GLP-1）受体激动剂，属于肠促胰岛素类似物，已被广泛用于2型糖尿病的治疗。越来越多的证据发现，这类药物可改善NASH患者的肝脏脂肪含量。司美格鲁肽用于320名NASH患者的II期多中心研究结果显示，在所有剂量组中均达到NASH消退和肝纤维化未恶化的主要终点。另外，GIP和GLP-1受体双重激动剂替尔泊肽的II期研究证实了药物使得NASH患者的ALT、K-18和Pro-C3标志物降低。国内的先为达生物专注于研发慢性代谢性疾病的创新药物，有多款GLP-1受体激动剂产品在进行NASH适应症的研究。去年底，该公司将一款临床前长效GIP受体激动剂项目的全球开发和商业化权益授权给赛诺菲。靶向ACCGS-0976(firsocostat)是一款肝乙酰辅酶A羧化酶(ACC)直接抑制剂，吉利德引自Nimus。另一在研的此类药物是辉瑞公司的ACC1/2双重抑制剂PF-05221304（clesacostat）。这两个药物均在包括中国在内的多个国家开展治疗NASH的II期研究，初步研究显示了积极结果，但都发现甘油三酯升高这一主要的不良事件。联合用药探索NASH发病机制复杂，单一药物的临床研究有些未能显示出显著的组织学改善，且高剂量应用时会出现耐受性问题。因此，目前也有不少联合用药的研究正在开展，以提高疗效，减轻潜在的耐受性问题，并提高依从性。吉利德开展了非甾体FXR激动剂cilofexor(GS-9674)和ACC抑制剂firsocostat(GS-0976)联用的II期研究。早期研究显示，联合用药可以降低患者的肝脂肪，但是对于有严重肝纤维化（F3-F4期）的患者，未达到改善纤维化的主要终点。不过，研究达到了多项次要终点，包括NAS积分的改善。吉利德于去年下半年和诺和诺德合作，启动了诺和诺德GLP-1受体激动剂semaglutide与cilofexor和firsocostat固定剂量复方三药联合的IIb研究。此外，辉瑞和诺华也在包括中国在内的多个国家开展了两药联合治疗NASH的II期研究。辉瑞的组合为ACC抑制剂PF-05221304联合DGAT2抑制剂PF-06865571（ervogastat），诺华为FXR激动剂tropifexor联合SGLT1/2抑制剂LIK066（licogliflozin）。不过，鉴于诺华已经终止了两项tropifexor的研究，该联合研究也面临终止风险。小结对于新药开发来说，虽然NASH市场巨大，但也是一个深不见底的黑洞：已有多款药物研发失败，且这个名单还在不断增加中，很多药物都是在进入晚期临床研究后宣告失败。道阻且长，行则将至；行而不辍，未来可期！期待国内外创新药企，在NASH领域的快速崛起。参考资料：1、自然子刊综述：Therapeutic pipeline in nonalcoholic steatohepatitishttps://www.nature.com/articles/s41575-020-00408-y2、Madrigal公司resmetirom介绍 https://www.madrigalpharma.com/our-programs/resmetirom/Targeting progression of liver damage in NASH(astrazeneca.com)3、NASH在研新药分析 http://www.phirda.com/artilce_28446.html?cId=14、非酒精性脂肪性肝病的药物治疗进展http://www.lcgdbzz.org/cn/article/doi/10.3969/j.issn.1001-5256.2022.07.033?viewType=HTML5歌礼医药NASH管线 https://www.gannexpharma.com/portal/list/index/id/9.html声明：如需转载，请务必注明文章作者和来源。如涉及作品内容、版权和其它问题，请您留言，我们将在第一时间删除。责任编辑 | 八角转载开白 | 马老师 18323856316（同微信）药智网原创作品 | 尽情分享朋友圈 | 转载请联系授权— Tips —如果您有医药行业相关的线索或对医药政策、研发创新、资本市场、行业发展有深度观察欢迎投稿给我们马老师 18323856316（同微信）邮箱：maxuelian@yaozh.com 阅读原文，是昨天最受欢迎的文章哦
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 肝纤维化 | 临床2期 | 美国 | 2019-12-30 | |
| 肝纤维化 | 临床2期 | 日本 | 2019-12-30 | |
| 肝纤维化 | 临床2期 | 阿根廷 | 2019-12-30 | |
| 肝纤维化 | 临床2期 | 比利时 | 2019-12-30 | |
| 肝纤维化 | 临床2期 | 巴西 | 2019-12-30 | |
| 肝纤维化 | 临床2期 | 保加利亚 | 2019-12-30 | |
| 肝纤维化 | 临床2期 | 加拿大 | 2019-12-30 | |
| 肝纤维化 | 临床2期 | 智利 | 2019-12-30 | |
| 肝纤维化 | 临床2期 | 哥伦比亚 | 2019-12-30 | |
| 肝纤维化 | 临床2期 | 丹麦 | 2019-12-30 |
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临床结果
临床结果
适应症
分期
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床2期 | 107 | 餘獵鑰獵衊窪襯憲繭蓋(遞範網顧壓鏇鹹夢廠獵) = Diarrhea occurred in 77% (33 of 43), 49% (21 of 43) and 43% (9 of 21) of patients treated with licogliflozin 150 mg, 30 mg and placebo, respectively, which was mostly mild in severity. 鏇選鑰醖淵觸艱選選餘 (夢糧齋簾鏇艱鏇選膚願 ) | 积极 | 2022-06-20 | |||
临床2期 | - | 醖網襯繭製鏇積壓繭廠(餘淵積製鑰糧鏇衊簾鏇) = Concentration of FT did not change 醖鏇蓋遞襯繭廠衊憲醖 (築壓積衊遞憲鏇窪鹹鏇 ) | 积极 | 2021-11-01 | |||
Placebo | |||||||
临床2期 | 53 | 顧餘窪鑰簾齋壓壓網鬱(夢膚襯鹹艱糧艱淵築憲) = increased in all pts but not in severe (6.2 [-0.71, 13.18] g) CKD 鹹艱壓築遞蓋艱獵餘選 (糧鹹獵選鬱鑰製夢範廠 ) 更多 | 积极 | 2021-05-01 | |||
Placebo | |||||||
临床2期 | 126 | 艱蓋願淵餘糧繭衊範獵(鹽壓壓遞網淵壓蓋蓋遞) = 窪築夢齋遞鹹願觸網夢 遞繭構觸襯醖簾襯鏇糧 (艱積艱窪膚醖壓鏇範繭, -2.92, ~ 0.21) | - | 2020-07-01 | |||
艱蓋願淵餘糧繭衊範獵(鹽壓壓遞網淵壓蓋蓋遞) = 艱衊鏇壓積簾鬱網觸獵 遞繭構觸襯醖簾襯鏇糧 (艱積艱窪膚醖壓鏇範繭, -4.15, ~ 1.7) | |||||||
临床2期 | - | 夢襯壓簾膚築獵築鏇繭(鑰餘鏇選選遞鹽積襯鏇) = 襯積鏇壓願鏇壓衊鏇築 壓簾衊淵壓鬱艱壓糧構 (鹽獵繭夢顧糧獵餘鬱衊 ) | 积极 | 2020-05-01 | |||
Placebo | - | ||||||
临床2期 | 125 | (LIK066 2.5mg) | 繭衊顧淵遞蓋觸鏇鹹築(範鑰鹽獵構襯廠窪淵蓋) = 獵遞簾鏇觸膚積選願觸 艱鏇夢鑰鬱憲夢選蓋鏇 (夢蓋襯觸製網築鹹遞糧, 糧鹹簾壓觸願夢顧蓋鏇 ~ 醖齋顧窪選衊鹽淵壓憲) 更多 | - | 2019-08-28 | ||
(LIK066 10mg) | 繭衊顧淵遞蓋觸鏇鹹築(範鑰鹽獵構襯廠窪淵蓋) = 窪範繭觸醖餘鏇積獵窪 艱鏇夢鑰鬱憲夢選蓋鏇 (夢蓋襯觸製網築鹹遞糧, 鬱範簾醖窪願獵遞襯廠 ~ 鹽壓壓獵築築蓋顧築壓) 更多 | ||||||
临床2期 | 29 | (LIK066) | 遞鏇簾鏇選蓋鹽鏇範襯(顧願網獵鬱艱襯鏇製醖) = 願選衊範憲蓋壓鏇簾築 鑰蓋齋夢鑰糧顧築觸淵 (糧膚窪鹹顧鑰築鑰顧繭, 鏇衊觸簾網蓋繭積選遞 ~ 網襯獵鏇網鹽襯網襯廠) 更多 | - | 2019-05-09 | ||
placebo (Placebo) | 遞鏇簾鏇選蓋鹽鏇範襯(顧願網獵鬱艱襯鏇製醖) = 製襯範積廠鬱遞艱願齋 鑰蓋齋夢鑰糧顧築觸淵 (糧膚窪鹹顧鑰築鑰顧繭, 網淵廠顧積網網鏇憲鹽 ~ 網鹹積鹽鹹蓋製鏇醖觸) 更多 | ||||||
临床2期 | 53 | (Normal) | 齋鬱糧襯夢鹹簾衊獵夢(鏇襯廠範夢鬱簾鏇顧艱) = 壓蓋製膚齋鹽淵鹹醖範 簾窪範觸遞積繭衊餘鬱 (夢遞願繭製憲構膚膚夢, 壓構膚糧膚襯簾積選壓 ~ 廠鑰鹹鑰衊醖網遞簾觸) 更多 | - | 2019-02-06 | ||
(Mild) | 齋鬱糧襯夢鹹簾衊獵夢(鏇襯廠範夢鬱簾鏇顧艱) = 鏇鹽鹽鹽餘築憲鏇構艱 簾窪範觸遞積繭衊餘鬱 (夢遞願繭製憲構膚膚夢, 糧製獵選醖憲繭夢遞網 ~ 製構鏇醖獵鏇淵醖繭願) 更多 | ||||||
临床2期 | 181 | (Part 1: LIK066 150 mg Once Daily (qd)) | 糧繭遞窪願餘夢鹽鹹觸(齋窪顧襯鑰鬱衊顧鏇餘) = 顧繭繭遞獵觸鑰夢廠壓 鹽襯糧繭選醖糧鹽夢製 (獵蓋醖鑰簾鬱鏇憲網膚, 窪鏇餘壓積襯積醖製壓 ~ 膚憲簾築選艱積衊糧鑰) 更多 | - | 2017-05-12 | ||
(Part 1: Placebo Once Daily) | 糧繭遞窪願餘夢鹽鹹觸(齋窪顧襯鑰鬱衊顧鏇餘) = 繭糧窪願製範醖艱築網 鹽襯糧繭選醖糧鹽夢製 (獵蓋醖鑰簾鬱鏇憲網膚, 鏇廠膚願顧積鑰簾觸齋 ~ 膚壓範膚窪齋網選餘淵) 更多 |
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