An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Rencofilstat in Healthy Male Subjects

This is a single-center, single-period, single-dose, open-label, non-randomized study to assess the mass balance recovery, metabolite profile and metabolite identification of 14C- labelled rencofilstat ([14C] CRV431). It is planned to enroll 6 healthy male subjects in a single group. Each subject will receive a single 225 mg oral dose of [14C] CRV431 self-micro emulsifying drug delivery system (SMEDDS) oral emulsion.

开始日期2023-03-01

申办/合作机构

Hepion Pharmaceuticals, Inc.

NCT05402371

/ Active, not recruiting临床2期

A Phase 2B, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rencofilstat in Adult Subjects With Nonalcoholic Steatohepatitis and Advanced Liver Fibrosis

This is a randomized, double-blind, placebo-controlled, parallel-dosing, multi-center study to evaluate the efficacy and safety of Rencofilstat as evidenced by histopathological improvements in fibrosis in adult NASH subjects with F2 or F3 fibrosis (NASH CRN system). Antifibrotic biomarker activity will be evaluated on an exploratory basis.

开始日期2022-10-15

申办/合作机构

Hepion Pharmaceuticals, Inc.

NCT05461105

/ Completed临床2期

ALTITUDE NASH: A Phase 2, Randomized, Multi-Center, Open-Label Study to Evaluate the Safety and Efficacy of Rencofilstat in Adult Subjects With Nonalcoholic Steatohepatitis Stage 3 Fibrosis

This is a randomized, open-label, parallel-dosing, multi-center study to evaluate the safety and efficacy of rencofilstat as evidenced by assessing changes in the HepQuant Shunt Disease Severity Index Score (DSI), safety labs, and clinical events in adult NASH subjects with compensated Fibrosis stage F 2/3. Antifibrotic biomarker activity will be evaluated on an exploratory basis.

开始日期2022-03-15

申办/合作机构

Hepion Pharmaceuticals, Inc.

100 项与 Rencofilstat 相关的临床结果

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100 项与 Rencofilstat 相关的转化医学

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100 项与 Rencofilstat 相关的专利（医药）

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项与 Rencofilstat 相关的文献（医药）

2025-11-01·British Journal of Pharmacology

Comprehensive analysis of extracellular matrix remodelling via cyclophilin inhibition in human models of alcohol‐related liver fibrosis

Article

作者: Kenny, Fiona N. ; Harris, Nicola ; Kerins, Caoimhe ; Adofina, Lissette ; Menon, Krishna ; Palma, Elena ; Amiri, Ramin ; Koay, Tsin Shue ; Ajayi, Omolola ; Chokshi, Shilpa ; Heaton, Nigel ; Srinivasan, Parthi ; Urbani, Luca ; Zen, Yoh ; Bozzano, Sergio Francesco ; Zamalloa, Ane ; Rastovic, Una ; Wei, Lai ; Luni, Camilla ; Campinoti, Sara ; Almeida, Bruna ; Ure, Daren ; Shaw, Tanya ; Miquel, Rosa ; Gentleman, Eileen

Background and Purpose:

Chronic liver disease and hepatic fibrosis constitute a threat to global health. Clinical translation of preclinical research has been limited, highlighting an urgent need for novel treatments. Cyclophilin inhibitors have shown beneficial effects in liver disease; however, the underlying mechanism of action and the effect across different aetiologies remain elusive. Here, we investigate the impact of a pan‐cyclophilin inhibitor (rencofilstat, RCF) in human models of fibrosis and alcohol‐related liver disease.

Experimental Approach:

RCF was tested in human precision‐cut liver slices (PCLS) and primary human hepatic stellate cells (HSCs). Fibrosis and cell activation were assessed using transcriptomic and protein analysis. A comprehensive characterisation of changes in extracellular matrix (ECM) biochemical and structural composition was performed in PCLS and HSC‐derived matrix using proteomics, imaging and bioinformatic tools to study ECM alignment. PCLS stiffness upon treatment was assessed by atomic force microscopy.

Key Results:

Transcriptomic and proteomic analyses of PCLS revealed a dramatic impact of RCF on ECM organisation and remodelling. Biochemical composition and fibre alignment analysis of the ECM obtained from HSCs showed a reduction in the amount of ECM core proteins and associated enzymes by RCF, reshaping the architecture of matrix fibres without affecting the HSC activation. The disordered matrix detected in RCF‐treated HSC cultures reflected a less‐stiff ECM, which was confirmed in the PCLS.

Conclusions and Implications:

This work provides evidence for a novel mechanism linking cyclophilins and ECM remodelling in advanced 3D models of liver disease, with potential applications in therapeutic development.

2025-03-01·Liver International

Rencofilstat Treatment Improves Liver Function in MASH With Advanced Fibrosis as Quantified by HepQuant DuO

Article

作者: Foster, Robert ; Zhao, Caroline ; Mayo, Patrick ; McRae, Michael P. ; Canizares, Carlos ; Harrison, Stephen A. ; Everson, Gregory T. ; Hobbs, Todd ; Helmke, Steve M.

ABSTRACT:

Background and Aims:

Rencofilstat inhibits cyclophilin to reduce hepatic inflammation and fibrosis, which, in turn, could improve liver function and reduce portal‐systemic shunting. Since HepQuant quantifies liver function and portal‐systemic shunting, it was used to measure the hepatic effects of rencofilstat treatment of MASH with advanced fibrosis.

Methods:

Seventy subjects with suspected ≥ F3 MASH, defined from liver biopsy or AGILE 3+ ≥ 0.53, were randomised to rencofilstat 75 mg/d (n = 24), 150 mg/d (n = 23) or 225 mg/d (n = 23), and tested by HepQuant at baseline, 60 and 120 days. The DuO version included oral dosing of d4‐cholate and two blood samples (20 and 60 min). DuO's disease severity index (DSI) and portal‐systemic shunting fraction (SHUNT%) were evaluated for changes from baseline at 60 and 120 days of rencofilstat treatment.

Results:

Across all subjects, there was a significant decrease in SHUNT% both at Day 60 (−1.67%, p = 0.0156) and Day 120 (−1.55%, p = 0.0441). In the 225 mg rencofilstat arm, 56% of subjects (10/18) were responders by Day 120 (p = 0.0549), and their DSIs improved with a mean change of −1.61 (p = 0.0190). Across all treatment arms, subjects with DSI > 18.3 at baseline had the greatest improvement with treatment (ΔDSI = −2.59, p = 0.0053).

Conclusion:

Although further studies are warranted, the decreases in DSI and SHUNT% suggest that rencofilstat 225 mg/d improves hepatic function and portal‐systemic shunting. HepQuant DuO is simple to administer, well‐tolerated and a useful tool for detecting the hepatic effects of treatment.

Trial Registration:

The study was registered at ClinicalTrials.gov, NCT05461105

2023-03-01·Clinical pharmacology in drug development

Effect of a High‐Fat Meal on Single‐Dose Rencofilstat (CRV431) Oral Bioavailability in Healthy Human Subjects

Article

作者: Mayo, Patrick R. ; Ure, Daren ; Hobbs, Todd M. ; Zhao, Caroline ; Remenchik, Ellen ; Foster, Erin P. ; Foster, Robert T. ; Greytok, Jill A. ; Trepanier, Daniel J.

Abstract:

Rencofilstat (RCF) is a novel cyclophilin inhibitor under development for the treatment of nonalcoholic steatohepatitis and hepatocellular carcinoma. This phase 1, randomized, open‐label study in healthy participants assessed the relative bioavailability of a single dose of RCF 225‐mg soft gelatin capsules in both fasted and high‐fat conditions. Forty‐four participants were enrolled to either the fasted (n = 24) or the high‐fat fed (n = 20) arm. Noncompartmental pharmacokinetics were evaluated following a single 225‐mg oral dose. Administration of RCF with a high‐fat meal led to increases in maximum concentration, area under the concentration–time curve (AUC) from time 0 to 24 hours, and AUC from time 0 to infinity fed‐to‐fasted geometric mean ratios of 102.2%, 114.5%, and 132.9%, respectively. All AUC geometric mean ratios were outside of the 80% to 125% range, suggesting that a high‐fat meal can increase the extent of RCF exposure. Time to maximum concentration increased from 1.5 to 1.8 hours in the fasted and high‐fat groups, respectively, suggesting slightly delayed absorption. High fat intake may delay gastric emptying while increasing the absorption and bioavailability of RCF. No treatment‐emergent adverse events were observed in the fasted group, and 1 treatment‐emergent adverse event occurred in the high‐fat meal group. The differences in observed whole‐blood concentrations are unlikely to have clinically relevant effects given the wide therapeutic index of RCF demonstrated in previous phase 1 studies.

112

项与 Rencofilstat 相关的新闻（医药）

2025-11-05

·凯美科

心血管与代谢疾病领域天然产物衍生药物的临床研发进展

前文内容，请点击以下链接：天然产物衍生药物的临床开发与审批现状综述(2014-2025) 感染性疾病领域天然产物衍生药物的临床研发进展神经系统疾病领域天然产物衍生药物的临床研发进展 5. 心血管与代谢疾病领域天然产物衍生药物临床评估进展天然产物（NPs）在心血管与代谢疾病治疗的发展中发挥了关键作用。例如：降胆固醇的他汀类药物源于真菌代谢物美伐他汀的启发377,378 首个GLP-1受体激动剂艾塞那肽-4，源自希拉毒蜥（Heloderma suspectum）唾液中的39个氨基酸多肽357,379 钠-葡萄糖协同转运蛋白（SGLT）抑制剂则从植物来源的糖基化查尔酮先导化合物根皮苷（5.03，第2节及本节）发展而来380,381 此外，植物来源的多酚、黄酮类化合物和ω-3脂肪酸具有抗炎、抗氧化和降脂作用，对动脉粥样硬化、高血压和糖尿病的防治具有贡献。表8汇总了正在开发用于心血管与代谢疾病的NP-D类化合物，下文将详细说明。表8 截至2024年12月31日心血管和代谢临床试验中的NP和NP-D化合物（按年份排序）阿帕贝塔隆（Apabetalone, 5.01，RVX-208，RVX000222）表观遗传调节剂 II/III期临床试验作用机制：溴结构域和超末端结构域（BET）蛋白拮抗剂382,383，通过表观遗传调控影响炎症、脂质代谢和血管疾病相关基因表达384。研发单位：Resverlogix Corp。靶点特性：特异性靶向BRD2、BRD3和BRD4蛋白，这些蛋白识别组蛋白上的乙酰化赖氨酸，调控炎症和动脉粥样硬化相关基因转录383。临床进展：计划开展II/III期试验（NCT06590324），针对服用达格列净且患有长新冠的2型糖尿病患者计划开展II期试验（NCT04915300），用于肺动脉高压此前III期试验（NCT02586155）未显示高危2型糖尿病患者主要不良心血管事件显著减少384,385 发现历程：通过旨在提升ApoA-I mRNA表达的表型筛选发现382，其结构设计基于植物多酚类化合物，但先导化合物结构未公开386。根皮苷（Phlorizin, 5.03）与格列净类药物（"gliflozins"）来源与特性：植物来源的二氢查尔酮糖苷，为非选择性SGLT抑制剂387–389。 SGLT亚型功能： SGLT1主要在小肠表达，抑制后可减少葡萄糖吸收、改善餐后血糖波动 SGLT2负责肾小球滤过葡萄糖的重吸收药物开发：自2012年以来，已有13种根皮苷启发的SGLT2选择性降糖药和1种SGLT1/SGLT2双效抑制剂（索格列净2.36，第2.1.3节）获批，统称为"格列净"类药物。荣格列净（Rongliflozin, 5.02，DJT1116PG） SGLT2抑制剂上市申请阶段研发单位：宜昌东阳光长江药业（HEC控股子公司）。剂型：L-焦谷氨酸盐390。最新进展：2024年1月11日向中国NMPA提交上市申请（CXHS2400002、CXHS2400003）。 SGLT抑制剂类药物 LH-1801（5.04） SGLT2抑制剂 III期临床试验药物类别：选择性SGLT2抑制剂（格列净类）391,392。研发单位：江苏联环药业。临床进展：正在开展两项III期试验：单药治疗（CTR20240399）及联合二甲双胍治疗（CTR20240385）。米扎格列净（Mizagliflozin, 5.05，KWA-0711） SGLT1抑制剂 II期临床试验药物类别：选择性SGLT1抑制剂393,394。研发背景：最初评估用于慢性便秘治疗395。Vogenx公司于2022年从Kissei制药获得日本、韩国、台湾以外地区开发权396。临床进展：近期公布II期试验（NCT05541939）阳性结果，针对减重术后低血糖患者的餐后血糖及胰岛素水平397,398 另有一项II期试验（NCT05721729）评估其对餐后血糖波动的影响 SY-009（5.06） SGLT1抑制剂 II期临床试验完成药物类别：SGLT1抑制剂399。研发单位：苏州亚宝药物研发有限公司。临床进展：2023年9月完成针对2型糖尿病的II期试验（NCT05426018）。 YG1699（结构未公开） SGLT1/SGLT2双效抑制剂 II期临床试验药物类别：SGLT1/SGLT2双效抑制剂400,401。研发单位：Youngene Therapeutics。临床进展：IIa期试验（NCT04956263）显示，在接受胰岛素泵治疗的1型糖尿病患者中，口服YG1699较达格列净更能降低餐后血糖402。 THDBH101（结构未公开） SGLT1/SGLT2双效抑制剂 I期临床试验完成研发单位：东宝滋兴（杭州）生物医药。临床进展：2023年完成I期试验（CTR20220031）。天然产物衍生代谢疾病治疗药物小檗碱熊去氧胆酸盐（Berberine ursodeoxycholate, 5.07，HTD-1801）天然产物复方 III期临床试验药物组成：小檗碱的熊去氧胆酸（ursodeoxycholic acid）盐403–405。研发单位：HighTide Biopharma。成分特性：小檗碱：植物来源季铵异喹啉生物碱，具抗炎、抗菌、降胆固醇及抗肿瘤活性406,407 熊去氧胆酸：用于治疗原发性胆汁性胆管炎等慢性胆汁淤积性肝病408 临床进展：正在开展三项针对2型糖尿病的III期试验（NCT06350890、NCT06353347、NCT06415773）。伏蒂光甘草定（Vutiglabridin, 5.08，HSG4112）异黄酮衍生物 II期临床试验完成药物类别：光甘草定（glabridin, 5.09）的外消旋类似物，生物利用度提升409。母体化合物：光甘草定为甘草根中异黄酮类化合物，具抗氧化、抗炎及抗动脉粥样硬化活性410。研发单位：Glaceum。临床进展： 2023年完成针对肥胖症的II期试验（NCT05197556）411 已注册帕金森病II期试验（NCT06329141），尚未启动作用机制：最新研究显示其为对氧磷酶2（PON2）激动剂，具有抗氧化应激保护作用412。光甘草定（Glabridin, 5.09）衍生物 HGR4113（5.10）：药物类别：光甘草定类似物413 研发单位：Glaceum 临床进展：近期启动I期试验（NCT05642377），评估其治疗2型糖尿病潜力作用特性：与伏蒂光甘草定（5.08）类似，具有抗炎活性414 前体药物与合成衍生物 TF0023（5.11，阿司匹林曲拉明）水杨酸前药 II期临床试验暂停药物类别：水杨酸（5.12）前体药物415。研发单位：Techfields Pharma。临床进展：曾开展针对缺血性卒中的II期试验（NCT02785120），因入组困难及公司运营问题暂停评估用于缓解COVID-19所致ARDS和肺炎症状的II期试验（NCT05212818），因缺乏参与者近期中止伯西波洛辛（Bersiporocin, 5.13，DWN-12088）常山碱类似物 II期临床试验药物类别：常山碱（febrifugine, 5.14）类似物。研发单位：大熊制药（Daewoong Pharmaceutical）。临床进展：正在开展II期试验（NCT05389215），用于治疗特发性肺纤维化。作用机制：为脯氨酰-tRNA合成酶1（PARS1）抑制剂，以不对称模式与PARS1二聚体各原聚体的催化位点结合，亲和力不同416,417。设计来源：基于常山碱卤化衍生物卤夫酮（halofuginone, 5.20）设计；常山碱为从中药常山（Dichroa febrifuga）中分离的抗疟喹唑啉酮生物碱418。异肌胺（Isomyosamine, 5.15，MYMD-1）生物碱类似物 II期临床试验完成药物类别：肌胺（myosmine, 5.16）和尼古丁（nicotine, 5.21）的类似物419,420。研发单位：TNF Pharmaceuticals（原MyMD Pharmaceuticals）。临床进展：2023年完成II期临床试验（NCT05283486），评估其治疗与肌肉减少症和衰弱相关的慢性炎症。作用机制：可抑制肿瘤坏死因子-α（TNF-α）的产生；TNF-α是一种免疫细胞信号蛋白和炎性细胞因子，在启动和维持炎症反应中起关键作用421。未来研究方向：TNF Pharmaceuticals计划评估5.15用于治疗桥本甲状腺炎和类风湿关节炎422。伦考司他（Rencofilstat, 5.17，CRV431）环孢菌素衍生物 II期临床试验药物类别：半合成环孢菌素（cyclosporin, 4.32，第4节）衍生物423。研发单位：Hepion Pharmaceuticals。临床进展：正在开展两项II期临床试验（NCT04480710424、NCT05402371），评估其治疗非酒精性脂肪性肝炎（NASH，现更名为代谢功能障碍相关脂肪性肝炎MASH）的疗效425–427。作用机制：与环孢素A（4.32）类似，为亲环蛋白（cyclophilin）抑制剂。 QG3030（5.18）二萜生物碱衍生物 I期临床试验药物类别：拉帕乌头碱（lappaconitine, 5.19）的半合成衍生物428,429。研发单位：Qgenetics。临床进展：近期启动I期临床试验，评估其治疗骨质疏松症及骨折的潜力430。母体化合物特性：拉帕乌头碱（5.19）为从北乌头（Aconitum sinomontanum）中分离的二萜生物碱，具有抗心律失常、抗炎及缓解慢性疼痛超敏作用429,431。待续广州凯美科信息技术有限公司是一家以化学信息学软件为核心业务的企业。公司成立于2019年10月，竭诚为国内医药、化工、食品等领域用户提供高质量的化学信息学软件解决方案和技术服务。作为加拿大ACD/Labs公司在国内的合作伙伴，我们在化合物结构鉴定、化学信息管理、色谱方法开发、化合物成药性评价、药物分子设计、分子模拟等方面累积了丰富的服务经验，并且得到广泛好评。产品包括(点击查看详情)： ✅ 化合物波谱解析系列 ✅ 化合物成药性预测 ✅ 化合物性质预测系列 ✅ 色谱方法开发系列 ✅ 实验室化学信息管理 —————————————————— ✅ 智能解析｜👉 [申请核磁/质谱解析软件演示]✅ 疑难攻坚｜📩 [提交疑难数据，获取专家支援]✅ 购买升级｜💼 [单位采购/版本更新/技术培训] 📢 联系我们：▔▔▔▔▔▔▔▔▔▔▔🧑 产品经理｜胡炽文📲 电话/微信｜18680221948📮 服务邮箱｜hcw@chemico.com.cn🌍 官网直达｜www.chemico.com.cn 扫码咨询

临床2期信使RNA临床1期核酸药物

2025-05-21

·求实药社

市值蒸发99.98%，现价仅剩0.04美元！这家Biotech转型去做诊断？

市值已蒸发99.98%，现价仅剩0.04美元Hepion成立于2013年，2014年在纳斯达克上市，是一家临床阶段的生物制药公司。公司专注于通过人工智能辅助的药物开发，主要聚焦非酒精性脂肪性肝炎（NASH/MASH）、纤维化疾病、肝细胞癌（HCC）及其他慢性疾病的治疗。其核心候选药物Rencofilstat是一款靶向亲环蛋白B的口服小分子抑制剂，曾获得FDA授予的MASH快速通道资格和HCC孤儿药资格，一度被视为具“广谱抗纤维化潜力”的明星管线。如今，这家公司即将退出舞台。目前Hepion已收到纳斯达克退市通知，因长期未达最低股价要求且被视为注册空壳，其股票将于2025年5月13日正式摘牌。自股价高点以来，公司市值已蒸发99.98%，现价仅剩0.04美元。不同于多数因毒性或无效而被放弃的项目，Rencofilstat并非“失败”。但在疗效标准频繁变动、GLP-1崛起、融资环境急剧恶化的三重冲击下，即便“达成多个关键终点”的产品，也可能无路可走。Hepion的选择，折射出当下Biotech所面临的集体焦虑。MASH项目终止，但并非“失败”Rencofilstat是一种亲环蛋白B抑制剂，该靶点是参与胶原蛋白折叠、合成与纤维化基质形成的重要酶，因而在多种肝纤维化疾病中具有治疗潜力。早期研究中，Rencofilstat在ALT、肝脂肪含量等指标上表现出一定改善趋势，随后公司启动了IIb期“ASCEND-MASH”试验，计划入组336人，但2023年4月即暂停招募，实际仅入组151例患者。到2024年4月终止时，约80人已完成一年访视。虽然尚未公布详细数据，公司表示结果达成多个关键终点，也未观察到安全性问题，但受限于资金，公司宣布中止开发。换句话说，Rencofilstat不是无效，而是“生不逢时”。早有征兆：CEO离职与战略重组事实上，Hepion的“转身”早有预兆。2023年12月，公司CEO Robert Foster博士因个人原因辞职，由首席财务官John Cavan担任临时CEO。Foster是Hepion早期发展的关键人物，其离任被认为标志着公司战略的深度调整。就在同一天，董事会通过了战略重组计划：削减约60%的运营成本，并启动包括并购、反向合并、许可协议或资产出售在内的多项“战略替代路径”。公司表示，截至Q3账上仅剩1928.4万美元现金，营运资金1490万美元，仅足以维持运营至2025年第二季度。GLP-1冲击下，MASH的“独立价值逻辑”动摇更为根本的冲击来自GLP-1的迅猛崛起。2024年，《新英格兰医学杂志》发布的III期ESSENCE试验显示，司美格鲁肽在MASH治疗中取得显著成效：62.9%的患者脂肪性肝炎缓解且无纤维化进展，对照组仅为34.3%；36.8%患者纤维化改善且炎症未恶化。该适应症sNDA已获FDA优先审评。虽然GLP-1尚未正式获批MASH适应症，但其通过减重、改善胰岛素抵抗和肝脂积聚，已实质性参与了MASH病程干预。更重要的是，其“代谢领域通用平台”逻辑极大增强了药物的多适应症价值，吸引了资本和监管的双重青睐。Evaluate Pharma预计，2024年GLP-1全球销售额已突破500亿美元，2030年将超1300亿美金。这意味着专为MASH开发的药物正在失去市场独立性、估值支撑和投资吸引力。从做药转向诊断，Hepion能走通吗？在多重压力下，Hepion最终决定彻底转型：从治疗药物研发转向体外诊断（IVD）测试。公司宣布与 New Day Diagnostics 签订许可协议，开发四项检测产品，覆盖呼吸道病原体（新冠/流感/RSV）、乳糜泻、幽门螺杆菌和肝细胞癌早筛。前三者已获得CE标志，可在欧洲销售；肝癌早筛则可能承接公司在肝脏疾病领域的经验。但从药物开发转向诊断，不仅代表战略重构，也面临重重挑战。这些检测方向虽具需求，但市场竞争激烈、差异化门槛高。Hepion尚未披露具体产品路径、临床验证计划或商业策略，成功与否仍未可知。结束语Hepion的转型，看似突兀，实则是Biotech在“融资退潮 + 临床不确定性 + GLP-1挤压”三重夹击下的典型应对。相比继续孤注一掷，主动止损、重构方向未尝不是一种更务实的选择。当GLP-1重塑代谢类药物格局，监管趋严、资本趋冷，MASH和其他热门靶点也难以幸免。Hepion的“转身”，或许并不光彩，但它足够真实——在当下的Biotech语境中，终局未必是“成药或失败”，更可能是“转身或沉没”。免责声明：文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部。联系我们国内唯一！多肽、代谢与减肥药领域顶尖盛会！PMO 2025展位火热预定中！扫码立即咨询电话：13816031174（同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多精彩！

高管变更孤儿药并购

2025-05-12

·hepionpharma.com

Hepion Pharmaceuticals Announces Receipt of Delisting Notification from Nasdaq

MORRISTOWN, N.J., May 12, 2025 (GLOBE NEWSWIRE) — Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company that had been developing a treatment for non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma (“HCC”), and other chronic liver diseases which has transitioned to a developer and distributor of diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), H. pylori and HCC, today announced that on May 9, 2025, the Company received written notice (the “Notice”) from the Office of General Counsel of The Nasdaq Stock Market (“Nasdaq”) indicating that the Nasdaq Hearings Panel has determined to delist the Company’s shares from Nasdaq due to the Company’s failure to meet Nasdaq’s continued listing standards. As previously disclosed, the Company has not been compliant with the requirements under Nasdaq Listing Rule 5550(a)(2) to maintain a minimum bid price of $1.00 per share and Nasdaq Listing Rule 5101 indicating that Nasdaq believes the Company is a public shell. The Notice indicated that trading in the Company’s shares of common stock (the “Common Stock”) on Nasdaq will be suspended effective at the open of trading on Tuesday, May 13, 2025. Upon suspension of the trading of its Common Stock on Nasdaq, the Company expects that its Common Stock will be quoted under its existing symbol “HEPA” on the OTC Markets Group. About Hepion Pharmaceuticals Hepion’s primary asset, Rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental disease models. In April 2024, Hepion announced that it was winding down its ASCEND-NASH clinical trial. This trial was designed as a Phase 2b, randomized, multi-center, double-blinded study with first patient screened in August 2022, to evaluate the safety and efficacy of Rencofilstat dosed for 12 months, with a target enrollment of 336 subjects. Enrollment was paused in April 2023, with 151 subjects randomized. To date, approximately 80 subjects have completed their Day 365 visits and are evaluable for both safety and efficacy. On May 9, 2025, Hepion entered into a license agreement with New Day Diagnostics LLC to in-license diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori (H. pylori) and hepatocellular carcinoma (HCC). The celiac, respiratory multiplex and H. pylori tests have CE marks and are eligible to be sold in Europe at the present time. Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. For further information, please contact: Hepion Pharmaceuticals info@hepionpharma.com

临床2期引进/卖出

100 项与 Rencofilstat 相关的药物交易

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研发状态

10 条进展最快的记录,

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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	Hepion Pharmaceuticals, Inc.	2020-06-23
肝纤维化	临床2期	波多黎各	Hepion Pharmaceuticals, Inc.	2020-06-23
代谢功能障碍相关脂肪性肝炎	临床2期	美国	Hepion Pharmaceuticals, Inc.	2020-06-23
代谢功能障碍相关脂肪性肝炎	临床2期	波多黎各	Hepion Pharmaceuticals, Inc.	2020-06-23
细菌感染	临床1期	美国	Hepion Pharmaceuticals, Inc.	2019-07-09
乙型肝炎	临床1期	美国	Hepion Pharmaceuticals, Inc.	2019-07-09
多发性骨髓瘤	临床前	美国	Hepion Pharmaceuticals, Inc.	2023-01-18

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临床结果

适应症

分期

评价

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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


NCT05737433 (CTgov)	早期临床1期	代谢功能障碍相关脂肪性肝炎	6	[14C]-rencofilstat 225mg	願選網範鏇艱積壓鏇夢 = 鑰積獵觸淵獵衊獵築糧製觸艱夢衊憲夢醖觸糧 (選築簾積齋鬱構遞繭襯, 顧構憲夢壓築憲壓憲願 ~ 窪選淵糧廠壓獵積鬱積) 更多	-	2024-10-03
ALTITUDE-NASH (GlobeNewswire) 人工标引	临床2期	代谢功能障碍相关的脂肪肝病	-	rencofilstat 225 mg	糧齋壓製簾獵觸鑰製襯(夢獵鑰糧選選築艱襯憲) = 憲醖艱鏇壓網顧簾糧構艱鬱蓋憲餘構餘積觸糧 (醖糧淵積構觸廠醖構鏇, -44.3 ~ -13.4)	积极	2023-11-13
NCT04480710 (AMBITION, NASH_TAG2022)	临床2期	代谢功能障碍相关脂肪性肝炎 transaminases \| ELF-score \| Pro-C3 ... 更多	43	CRV431 75 mg	鬱鏇醖築鹹齋夢鬱艱網(淵顧製願壓餘鏇糧衊窪) = 範製範鬱襯獵顧餘製憲淵壓廠製襯繭襯淵襯鹽 (膚齋鹽艱構鹹糧艱窪顧 ) 更多	积极	2022-01-06
				CRV431 225 mg	鬱鏇醖築鹹齋夢鬱艱網(淵顧製願壓餘鏇糧衊窪) = 窪網獵鬱齋糧繭遞醖選淵壓廠製襯繭襯淵襯鹽 (膚齋鹽艱構鹹糧艱窪顧 )
EASL2019	临床1期	HBV DNA \| HBsAg \| HBeAg ... 更多	32	CRV431 75 mg	鬱網艱艱範膚壓鑰蓋窪(壓築衊築築遞淵願鏇築) = Safety results demonstrated that CRV431 was well tolerated with no serious adverse events (SAE), no dose-limiting toxicities or dose-dependent adverse events. Overall, the incidence of adverse events and laboratory abnormalities was low and similar among cohorts. All AEs were mild and not drug related. 製鹽廠製顧夢構壓願廠 (構醖遞顧餘鹹選鬱積淵 ) 更多	积极	2019-04-12
				CRV431 225 mg
NCT00553735 (CTgov)	临床4期	干眼综合征 \| 移植物抗宿主病	8	Cyclosporine A (Cyclosporine A 0.05%)	醖窪醖壓鏇夢夢糧蓋夢 = 繭繭憲簾鹽鑰夢遞選製觸壓簾顧憲壓窪壓壓範 (壓艱鹹簾衊壓構製繭齋, 膚醖壓憲鬱製鬱網願繭 ~ 選憲糧艱範淵壓製壓選)	-	2017-03-28
				Arificial Tear (Artificial Tear)	醖窪醖壓鏇夢夢糧蓋夢 = 顧糧壓壓艱夢艱鹹醖積觸壓簾顧憲壓窪壓壓範 (壓艱鹹簾衊壓構製繭齋, 網獵鹽繭鏇鹹鑰製餘齋 ~ 膚憲鬱鹹簾糧顧壓網繭)